Upstream Biotechnology Jobs in Usa

327 positions found

Biotechnology Laboratory Assistant
Salary not disclosed
Vacaville, CA 3 days ago

This is a six month assignment in Vacaville

This potsition is for local candidates as there is no travel and living expenses

This is a W2 Position.


Process Engineer I


Summary:

This position is located at Lonza’s production facility in Vacaville, California. The production facility makes pharmaceutical proteins from mammalian cells using large-scale production techniques. This temporary contract position provides hands-on technical support for Process Analytical Technology (PAT) systems deployed on the manufacturing floor at a large-scale biopharmaceutical facility. PAT systems play a critical role in monitoring mammalian cell culture processes by measuring key parameters such as cell density, viability, and metabolite concentrations. Maintaining these systems in a reliable, ready-to-use state is essential for ensuring consistent manufacturing performance.

In this role, you will support day-to-day operation, maintenance, and troubleshooting and repair of PAT instruments used in GMP manufacturing. You will work closely with the Frontline Upstream (FLUS) System Owner, Manufacturing, and Instrumentation staff to assess system issues, perform equipment health checks, execute planned improvements, and assist with investigations into unplanned events. This position supports the increased workload associated with the deployment of several new PAT systems in parallel with existing instruments. This position offers the opportunity to gain hands-on experience with advanced PAT used to support mammalian cell culture and purification operations. The FLUS and Instrumentation groups provide technical support for a wide range of analytical instruments used to monitor cell growth, metabolite profiles, and process performance throughout the manufacturing lifecycle.


Job Duties:

Responsibilities/activities may include, but not limited to:

• Performing routine maintenance, calibration checks, and system readiness activities for PAT instruments such as cell counters and metabolic analyzers (e.g., Cedex Bio, Cedex HiRes, Cedex Cobas).

• Supporting manufacturing operations by responding to system-related issues, troubleshooting instrument performance, and documenting observed problems.

• Assisting in the investigation of unplanned equipment events using structured problem-solving tools and contributing to root cause assessments.

• Conducting equipment health monitoring and contributing to reliability improvement activities to increase system uptime.

• Executing planned equipment changes, minor upgrades, and configuration updates under the direction of the PAT System Owner.

• Reviewing and interpreting instrument data to identify basic trends or abnormalities.

• Supporting adherence to data integrity principles and helping maintain data consistency within systems such as Smartline Data Cockpit.

• Collaborating with Manufacturing, FLUS, Automation, QA, and vendors to ensure systems are functioning as intended.

• Assisting with documentation updates, tracking of work activities, and preparing technical summaries as needed.

• Working independently to accomplish assigned tasks while keeping stakeholders informed of progress.


Education and Experience:

• B.S., M.S., or Ph.D in an engineering or analytical/scientific discipline.

• Prior hands-on experience with analytical systems is required.

• Experience using cell counters and metabolite analyzers (Cedex Bio, Cedex HiRes, Cedex Cobas) in GMP Manufacturing or QC Labs preferred.

Knowledge/Skills/Competencies:

• Working knowledge of current Good Manufacturing Practices (cGMPs) as applied to biopharmaceutical manufacturing or similar regulated industries.

• General understanding of biotech analytical methods and laboratory practices.

• Experience troubleshooting analytical instruments and interpreting equipment performance data.

• Flexibility in problem solving and work hours to meet business objectives.

• Familiarity with data management systems; experience with Smartline Data Cockpit is highly desirable.

• Strong interpersonal and communication skills; able to work effectively with operators, engineers, scientists, and external vendors.

• Ability to work independently and manage assigned tasks with limited supervision.

• Demonstrated ability to evaluate technical situations, propose solutions, and execute corrective actions.

• Strong verbal and written communication skills, including documentation, reporting, and stakeholder updates.

• Ability to build productive working relationships with end users and equipment vendors.

• Strategic thinking mindset with the ability to convert system needs into actionable activities.

• Builds productive relationships with partners; focuses on customer needs.

Not Specified
Instructor Pool - Clinical Research, Regulatory Affairs, and Biotechnology - UCBerkeley Extension
✦ New
Salary not disclosed
San Francisco, CA 1 day ago
Position overview

Position title:
Instructor (Non-Senate, Non-Tenure Track)

Salary range:
The compensation model varies depending upon the course delivery format. For a synchronous Live Online course, a reasonable estimate for this position is $1,500 - $4,500 total per course. For an asynchronous Fixed Date Online course, this position is paid $200 - $350 per enrolled student and a reasonable estimate ranges from $1,600 -$5,250 total per course. Instructor compensation is determined by course length, number of units, enrollment, budgetary considerations, and other factors.

Percent time:
Part-time by agreement on a course-by-course basis.

Anticipated start:
Some appointments may begin as early as the spring semester.

Review timeline:
Applicants are considered for positions as needs arise; the existence of this applicant pool does not guarantee that a position is available. The applicant pool will remain in place for 9-12 months; those interested in remaining in the applicant pool beyond the advertised final closing date must reapply.

Position duration:
Length of courses differs depending on the subject, level, format/schedule, and credits taught. For the fall, spring, and summer semesters, course length typically ranges from approximately 2 days to 8 weeks. Further course agreements may be assigned based upon program needs, meritorious performance, and funding availability.

Application Window


Open date: August 27, 2025




Next review date: Monday, Mar 23, 2026 at 11:59pm (Pacific Time)

Apply by this date to ensure full consideration by the committee.




Final date: Wednesday, Aug 26, 2026 at 11:59pm (Pacific Time)

Applications will continue to be accepted until this date, but those received after the review date will only be considered if the position has not yet been filled.



Position description

UC Berkeley Extension (UNEX), the continuing education branch of the University of California, Berkeley, has been building bridges between UC Berkeley and the public since 1891. UNEX serves the professional and continuing education goals of thousands of people each year and plays an essential part of the University mission to: extend the research and scholarship of UC Berkeley to a global community; increase access to higher education for non-traditional, online, and international students; and improve the workforce. UC Berkeley Extension is a part of the division under the leadership of the Dean of Extended Education that also includes Berkeley Summer Sessions, Berkeley Study Abroad, and Osher Lifelong Learning Institute.



UC Berkeley Extension invites applications for a pool of qualified, dynamic instructors with a commitment to undergraduate, professional, and continuing education in Clinical Research, Regulatory Affairs, and Biotechnology to teach one or more online courses each year for our Sciences, Mathematics, and Biotechnology department.



Courses are offered online:




  • Online instruction is delivered asynchronously through our learning management system (Canvas) or through synchronous live lectures (Zoom).
  • Most synchronous live online lecture courses are offered in the evening and on the weekend (U.S.A. Pacific Time).


Course Subjects

We are seeking qualified applicants who possess current subject matter expertise and/or teaching knowledge in (but not limited to) the following course subjects. For program and course descriptions, please refer to the departmental link below.



Clinical Research




  • Introduction to Clinical Research: Clinical Trial Phases and Design
  • Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities
  • Clinical Trial Implementation: Site Initiation, Subject Recruitment, Monitoring and Safety Reporting
  • Clinical Trial: Data Analysis, Regulatory Audits, Vendor Selection and Project Management


Regulatory Affairs




  • Principles of Regulatory Affairs: Pharmaceuticals and Medical Devices
  • Submissions and Commercialization
  • Preparation, Submission and Agency Interfacing
  • Harmonization Across Worldwide Applications
  • Post-Approval Activities
  • Principles of Supply Chain and Manufacturing
  • Principles of Product and Process Development
  • Principles of Quality and Compliance
  • Regulatory Compliance for Pharmaceutical Products


Other Biotechnology Courses




  • Drug Development Process
  • Other Biotechnology course topics (please specify in your cover letter)


Teaching Experience




  • Classroom Teaching Experience
  • Synchronous Online Teaching Experience (online lectures via Zoom)
  • Asynchronous Online Teaching Experience (via learning management system)


General Duties

The department seeks candidates who can support the success of all students through inclusive curriculum, classroom environment, and pedagogy. Specific duties and expectations will vary depending on the method of instruction including: Synchronous Live Online (Zoom) or Asynchronous Online (Fixed Date).




  • For synchronous instruction (live online courses), duties include but are not limited to: syllabus development; assignment development; lesson planning for class meetings; preparing and submitting required texts and course materials; reviewing and updating Canvas course site; and delivering lectures, presentations, and learning activities for all required hours of instruction.
  • For asynchronous instruction (fixed date online courses), duties include but are not limited to: reviewing the syllabus and pre-populated online course content; learning and utilizing Canvas classroom management tools; and requesting any training needs from the Program Director or Department Director.
  • For all instruction (regardless of course format) duties include but are not limited to: completing required trainings as mandated by the UC Presidential policies; responding to student questions and learning needs in a timely manner; grading student assignments and posting final student grades to the instructor portal in a timely manner; utilizing University-approved course support platforms including the Canvas Learning Management System, Zoom, Instructor Portal, Google Workspace, etc.; reviewing and following University and departmental policies, logistics, and other guidelines as published on the departmental Instructional Resource Site; and responding to other requests from the Program Director or Department Director in a timely manner.


Clinical Research Conduct and Management Program: public/category/ ?method=load&certificateId=17168&selectedProgramAreaId=15498&selectedProgramStreamId=15604

Regulatory Affairs Program: public/category/ ?method=load&certificateId=17180

Clinical Research, Regulatory Affairs, and Biotechnology Courses: academic-areas/sciences-and-biotechnology/?nav=5#!?tab=courses&programStream=Life%20Science%20Business%20and%20Biotechnology



Qualifications

Basic qualifications (required at time of application)

  • Advanced degree


Additional qualifications (required at time of start)


  • U.S.A. Residency and U.S.A. Work Authorization: All work must be performed in the United States, whether in person or online. For applicants who are not US citizens or permanent residents, a valid US work authorization is required for the duration of employment. Applicants should not expect the department to sponsor a work visa on their behalf.


Preferred qualifications

  • Doctorate degree or equivalent international degree in course subject.
  • 3 or more years of teaching, training, or coaching experience in the course subject at a U.S. college/university institution, or within a U.S. Clinical Research, Regulatory Affairs, or other Biotechnology corporate environment.
  • Knowledge of federal and California state laws and regulations as applicable to the course subject.
  • Professional license, certification, or credential within a Clinical Research, Regulatory Affairs, or other Biotechnology field.
  • Experience in creating syllabi, learning objectives, lectures/presentations, learning activities, assignments, assessments, exams, and quizzes.
  • Experience teaching and/or developing academic content for online courses.
  • Ability to convey conceptual and complex ideas and information.
  • Ability to support the success of all students through inclusive curriculum, classroom environment, and pedagogy.
  • Effective verbal/written communication and presentation skills (English).
  • Effective organizational skills with attention to detail.
  • Ability to collaborate with colleagues and work within a team environment.
  • Proficiency in (or willingness to learn) instructional and other technology, such as: Learning Management Systems (Canvas); lecture/presentation capture applications (Panopto); online video conferencing (Zoom); Microsoft Office (Word and PowerPoint); file sharing (Google drive or Dropbox); and Google Workspace tools (email, calendar, docs, sheets, slides, etc).


Application Requirements

Document requirements

  • Curriculum Vitae - Your most recently updated C.V.


  • Cover Letter - Please discuss prior teaching experience, teaching approach, and other/future teaching interests. This can include, for example, specific efforts, accomplishments, and future plans to support the success of all students through inclusive curriculum, classroom environment, and pedagogy.




Reference requirements

  • References are requested from candidates at the interviewing stage, and references are only contacted for finalists.


Apply link:
JPF04761

Help contact:



About UC Berkeley

UC Berkeley is committed to diversity, equity, inclusion, and belonging in our public mission of research, teaching, and service, consistent with UC Regents Policy 4400 and University of California Academic Personnel policy (APM 210 1-d). These values are embedded in our Principles of Community, which reflect our passion for critical inquiry, debate, discovery and innovation, and our deep commitment to contributing to a better world. Every member of the UC Berkeley community has a role in sustaining a safe, caring and humane environment in which these values can thrive.



The University of California, Berkeley is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or protected veteran status.



For more information, please refer to the University of California's Affirmative Action and Nondiscrimination in Employment Policy and the University of California's Anti-Discrimination Policy.



In searches when letters of reference are required all letters will be treated as confidential per University of California policy and California state law. Please refer potential referees, including when letters are provided via a third party (i.e., dossier service or career center), to the UC Berkeley statement of confidentiality prior to submitting their letter.



As a University employee, you will be required to comply with all applicable University policies and/or collective bargaining agreements, as may be amended from time to time. Federal, state, or local government directives may impose additional requirements.


Unless stated otherwise, unambiguously, in the position description, this position does not include sponsorship of a new consular H-1B visa petition that would require payment of the $100,000 supplemental fee.



As a condition of employment, the finalist will be required to disclose if they are subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct.




  • "Misconduct" means any violation of the policies or laws governing conduct at the applicant's previous place of employment, including, but not limited to, violations of policies or laws prohibiting sexual harassment, sexual assault, or other forms of harassment or discrimination, as defined by the employer.
  • UC Sexual Violence and Sexual Harassment Policy
  • UC Anti-Discrimination Policy
  • APM - 035: Affirmative Action and Nondiscrimination in Employment


Job location
San Francisco Bay Area, California, U.S.A.
Not Specified
Biotechnology Laboratory Associate
✦ New
Salary not disclosed
Vacaville, CA 1 day ago

Title: Manufacturing Associate – Biotech/Biotechnology Laboratory Associate

Location: Vacaville, CA – 95688

Duration: End of the year - 12/31/2026

Rate details:

Day shift (Shift 1): $25.00/hr

Night shift (Shift 3): $27.50/hr

Description:


Shifts and Hours schedule:

Day Shift: 6am - 7pm

Night Shift: 6pm - 7am

- These roles follow a 3-4-3 shift pattern

Role Purpose:

The Manufacturing Associate is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.

40% Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate

20% Attain qualification for all assigned tasks and maintain individual training plan

10% Perform basic laboratory tasks, such as monitor pH, conductivity, test product samples, etc.

10% Perform material movements, transfer raw materials, chemicals into, out of, across the production areas.

10% Maintain facility and equipment through routine cleaning and sanitization, support 6S programs

10% Administrative tasks – attending shift exchange, meetings, sending/receiving emails, participating in projects, perform other duties as assigned.

High School Diploma or Equivalent minimum; AS/BS preferred

Preferred area of study: Science related discipline

0-3 years’ experience; some prior experience in a manufacturing setting preferred.

Proven logic and decision making abilities, critical thinking skills

Not Specified
Corporate Counsel/Sr. Corporate Counsel
✦ New
Salary not disclosed
Waltham, MA 1 day ago

Position Summary:

We are seeking a highly motivated attorney to join our legal team as Corporate Counsel/Sr. Corporate Counsel. This role will support the company’s public company reporting obligations, corporate governance processes, compliance initiatives, and contracting activities across the organization. Title and level will be determined based on experience and scope of responsibility.


This position is well-suited for a life sciences attorney who thrives in a fast-paced, clinical-stage biotech environment and enjoys partnering with cross-functional teams to provide practical legal guidance. The role requires strong attention to detail, sound judgment, and the ability to manage a broad range of legal matters in a growing organization.


The successful candidate will work closely with the General Counsel and senior leadership, partnering with teams across Finance, Investor Relations, Clinical Development, Regulatory, Technical Operations, and HR, and coordinating with external counsel as needed.


Key Responsibilities:


Securities & Corporate Governance

  • Assist in the preparation and review of SEC filings, including Forms 10-K, 10-Q, 8-K, proxy statements, and Section 16 filings.
  • Partner with Finance and Investor Relations to support the company’s disclosure processes, planning and drafting, including for earnings releases, investor presentations, and proxy materials.
  • Monitor and advise on securities law compliance, including Nasdaq listing standards, Sarbanes-Oxley requirements, and insider trading policies.
  • Provide legal support for capital markets transactions, including equity offerings and financings common in clinical-stage biotech companies.
  • Support Board of Directors and committee governance activities, including preparation of board materials and maintenance of governance documentation.
  • Provide legal guidance on corporate governance and regulatory requirements affecting the organization.
  • Partner with HR and leadership on matters including equity plans and corporate policies.


Healthcare, Data Privacy, and Corporate Compliance

  • Serve as a trusted advisor to senior leadership and cross-functional teams on business and compliance strategies, establishing the Compliance function as an approachable, knowledgeable, practical, and solutions-oriented business partner.
  • Assist with the development and maintenance of policies and procedures to support the company’s corporate governance initiatives, healthcare compliance programs, and privacy framework, including the company’s code of business conduct and ethics.
  • Serve as the go-to internal lead for guidance concerning compliance-related regulations, including data protection, information security, GDPR, and HIPAA, and monitor changes in healthcare compliance and data protection requirements to operationalize “fit for purpose” program updates.
  • Coordinate and support the company’s privacy program activities, including Data Protection Impact Assessments (DPIAs), Records of Processing Activities (RoPAs), data mapping, maintenance of related documentation, and facilitation of data subject requests.
  • Lead risk assessments to identify and prioritize compliance-related risks.
  • Develop and deliver risk-based compliance training and guidance materials for employees across the company.
  • Partner with the company’s Information Technology team to mitigate information security-related risks, including risks related to AI adoption, privacy matters, and cybersecurity incidents.


Contracting Matters

  • Draft, review, and negotiate a wide range of life sciences agreements, including:
  • Clinical trial agreements
  • CRO and vendor agreements
  • Manufacturing and supply agreements
  • Licensing and collaboration agreements
  • Research and development agreements
  • Technology and services agreements
  • Serve as a legal partner to cross-functional teams including Clinical Development, Regulatory, Technical Operations, R&D, and G&A functions.
  • Support negotiation of complex and high-impact agreements, liaise with our clinical research organizations (CROs) to manage all aspects of contracting processes for large scale clinical trials, and escalate strategic matters as appropriate.
  • Contribute to the development of contract templates, playbooks, and contracting best practices to improve efficiency and consistency.


Cross-Functional Legal Support

  • Partner with the General Counsel and legal team on a variety of matters affecting the organization.
  • Provide legal support on issues arising throughout the drug development lifecycle, including regulatory, operational, and compliance considerations.
  • Coordinate with external counsel and internal stakeholders to support key legal initiatives and transactions.
  • Contribute to a collaborative, business-oriented legal function that supports the company’s mission and growth.


Qualifications:

  • J.D. from an accredited law school and admission to practice in at least one U.S. jurisdiction.
  • 6+ years of legal experience, including corporate securities, compliance, and/or commercial contracting experience at a top law firm and/or public life sciences company.
  • Strong knowledge of SEC regulations, Sarbanes-Oxley, public company disclosure requirements, and stock exchange listing standards.
  • Experience drafting and negotiating complex life sciences or other agreements, particularly those supporting clinical development and technical operations.
  • Understanding of drug development lifecycle and regulatory environment impacting biotechnology companies.
  • Excellent analytical, communication, and stakeholder management skills.
  • Ability to manage multiple priorities, make decisions with incomplete information, and operate effectively in a fast-paced, collaborative environment.


Preferred Experience:

  • Experience supporting a clinical-stage biotechnology or pharmaceutical company.
  • Familiarity with clinical development operations, CRO agreements, manufacturing agreements, and licensing transactions.
  • Experience supporting public company reporting and governance processes.
  • Experience working in a lean legal team environment with exposure to a broad range of legal matters.
  • Demonstrated project management skills, including successful execution of complex projects with multiple stakeholders and utilization of soft skills to maximize team collaboration and effectiveness.


About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at .


Compensation

Target Salary Range: $234,000 -$286,000

*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the company’s cash bonus and equity incentive programs. Additional benefits include health care, vision, dental, retirement, PTO, etc.

Not Specified
Associate Director, Quality Control
🏢 Upstream Bio
Salary not disclosed
Waltham, MA 2 days ago

Position Summary:

The Associate Director, Quality Control will be responsible for providing strategic, scientific, and operational leadership for the development, qualification, validation, and lifecycle management of analytical methods supporting Upstream Bio’s lead program verekitug. This role will manage and execute GMP quality control (QC) activities directly related to batch release for clinical trial material supply. The leader in this role must assure that quality controls for investigational new drugs (investigational medicinal products) meet all quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations. The Associate Director will report to Senior Director of Analytical and serve as a key partner to Quality, CMC, Regulatory, and cross-functional teams. This individual will provide technical guidance and business acumen to ensure execution of analytical activities for late-stage programs through BLA/MAA submission, approval, and commercial launch.


Key Responsibilities:

  • Author, review and approve analytical method procedures/SOPs
  • Author, review and approve analytical method transfer/qualification/validation protocols and reports
  • Manage external CDMOs and CROs to execute Development and GMP release and stability testing of Drug Substance and Drug Product in a compliant-manner
  • Establish and manage reference standard and critical reagent programs
  • Participate in the laboratory quality system activities such as internal audits, writing standard operating procedures, and documentation review.
  • Perform data verification and audits in order to ensure accuracy of data and analytical processes.
  • Ensure compliance with company policies and SOPs as well as global health authority guidelines.
  • Create, analyze, verify, and approve QC data such as method validation, release and stability, results, reports, and Certificates of Analysis (COAs).
  • Generate, review, and revise specifications, SOPs, and other QC laboratory and testing documentation.
  • Lead Out-of-Specification (OOS), Out-of-Trend (OOT), and Deviation investigations related to the QC laboratory and ensure effective corrective and preventive actions (CAPAs) are implemented.


Qualifications:

  • Experience in stability study performance/evaluation and/or knowledge/familiarity with USP/compendial testing is helpful.
  • Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential.
  • Proficiency with Microsoft software (Word / EXCEL / PowerPoint), Stability software and statistical analysis/trending to support shelf life and labeling is expected.

Knowledge and skills (general and technical) preferred:

  • Broad background, strong comprehension, and demonstrated skills in analytical methods development/validation/transfer/similar, reference standards characterization/structural elucidation, and unknown identification.

Education level and/or relevant experience required:

  • Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of demonstrated success in leading cross-functional teams and managing projects along with 7+ years relevant analytical experience in a cGMP-compliant pharmaceutical laboratory environment. Any ASQ or other certifications is a plus.


About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at .


Compensation

Target Salary Range: $176,400 - $215,600

*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

Not Specified
Process Engineer
Salary not disclosed
Albany County, NY 2 days ago

Location: On-site in Upstate NY (Relocation from Canada welcome!)


Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.


ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.


ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.


This is an outstanding opportunity to join our growing team!


Full-Time | Onsite

About the Role:

We are seeking a detail-oriented and technically proficient Process Engineer who will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.


Responsibilities

  • Work with Upstream equipment
  • Fermentation
  • Process optimization
  • Process scale-up or scale-down studies
  • Commissioning and Qualification
  • Protocol generation and execution
  • Data analysis
  • Report writing
  • Author SOPs
  • Great communication skills (presenting, and writing)
  • Protein expression/purification
  • GxP (GDP, GLP, or GMP a major asset)


Minimum Requirements

  • Bachelor’s or master’s degree in Biochemistry, Biology, Mechanical Engineering, Chemical Engineering, Biochemical Engineering, or related discipline.
  • Required: 3+ years of experience in the biotech-pharmaceutical academic or industrial environment.
  • Bioprocess experience preferred
  • Fill finish experience preferred
  • Basic knowledge of upstream/downstream drug substance manufacturing.
  • Basic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations. Familiarity with ICH guidelines and EMA regulations is a plus.
  • Basic technical writing with proficiency in Excel, PowerPoint, Visio, Word, Sharepoint, etc. in addition to experience working within shared work environments.
  • Demonstrated experience with manufacturing processes and equipment such as CIP systems, bioreactors, filtration skids, chromatography and lyophilization equipment.
  • Basic knowledge of the Commissioning and Qualification.
  • Travel within USA as needed for the projects.


Perks & Benefits:

  • Competitive salary
  • Full health, dental, vision, and retirement benefits
  • Tuition reimbursement, PTO, and more
Not Specified
Senior Product Manager
✦ New
Salary not disclosed
Ann Arbor, MI 1 day ago

PRODUCT MANAGER

Ann Arbor, MI


Are You Ready to Help Shape the Voice and Vision of Zomedica?

At Zomedica, marketing is more than campaigns — it’s about strategy and product leadership. We’re looking for a product manager with a creative mindset to own the product roadmap and long-term vision, help drive adoption, and increase product demand for our growing portfolio of animal health solutions.


In this role, you’ll focus on upstream product management to shape how products are positioned, launched, and supported in the market. If you thrive at the intersection of creativity and business strategy, this is your opportunity to make a lasting mark.


What’s in It for You?

  • Product Leadership – Play a hands-on role in product launches, market positioning, and lifecycle management.
  • Career-Defining Growth – Expand your expertise in both marketing and product management within a fast-growing, innovative company.
  • Cross-Functional Impact – Collaborate with sales, R&D, and leadership to align go-to-market strategies and drive adoption.


Are You Ready?

We believe in bold ideas, fresh perspectives, and building products that make a real difference in animal health. If you’re ready to combine your marketing expertise with product leadership and play a critical role in shaping Zomedica’s future, we’d love to hear from you.


In this role, you will contribute to the long-term vision, strategy, and roadmap for assigned product portfolios, working closely with the sales organization to increase product demand and drive sales. This role is responsible for upstream product management to drive product positioning and provide sales process support.


Responsibilities will include:

  1. Develop and execute go-to market strategies and tactical plans for assigned product portfolios.
  2. Define the product roadmap, including creating and maintaining marketing materials and developing communication strategies.
  3. Serve as the product lead in new product development and product support teams.
  4. Recommend scope of present and future product lines.
  5. Gain competitive intelligence to understand the market and customer needs to grow the business.
  6. Provide competitive market and product information and voice-of-customer inputs to product development and marketing teams.
  7. Recommend product pricing by utilizing market research, production and sales costs, and anticipating volume.
  8. Collaborate with the sales team to drive sales through regular customer visits, both virtually and on-site, and in the field making sales calls with account managers.
  9. Translate market trends into a compelling product direction and vision.
  10. Translate product features into tangible benefits that meet customer needs.
  11. Serve as customer and user champion to ensure that product interface, features, and experience reflect voice-of-customer input, market needs, and corporate delivery objectives.


Job requirements and skills:

  • Bachelor’s Degree in a related discipline; education or background in Engineering, Biotechnology, or other scientific / technical field preferred.
  • 7+ years of related experience in product management / animal health / medical device marketing, with experience in capital marketing, and demonstrated success in launching new products.
  • Excellent written and verbal communication skills, with strong influencing skills to gain commitment and support for decisions.
  • Proven ability to work effectively cross-functionally and with all levels with an organization.
  • Must be organized, with proven ability to manage multiple priorities and meet deadlines.
  • Solid analytical and critical thinking skills; attention to detail balanced with the ability to see the big picture.
  • Experience with digital marketing platforms and CRM tools a plus.
  • Ability to travel up to ~25%.





Zomedica offers excellent compensation and incentives, a competitive benefits package with medical insurance, employer-paid dental / vision / disability / life insurance, a 401k plan with a Company match, generous PTO and paid holidays, a collaborative work environment, and great growth potential. As part of the Zomedica team, you will have the unique opportunity to share in the Company's success. Join our growing team of talent dedicated to advancing care for the pets we love! Zomedica is an equal opportunity employer.

Not Specified
Life Sciences Patent Prosecution Associate Attorney (3+ Years) – New York, New York- 410750
✦ New
Salary not disclosed
New York, NY 1 day ago

Job ID: 410750


Practice area:- IP - Patent - Biochemistry,IP - Patent - Bioengineering,IP - Patent - Biotechnology,IP - Patent - Cellular Technology,IP - Patent - Genetics,IP - Patent - Medicine,IP - Patent - Molecular Biology


Life Sciences Patent Prosecution Associate Attorney (3+ Years) – Biotechnology & Molecular Biology | New York, New York


Keywords:- Patent Associate Attorney, Biotechnology Patent Attorney, Life Sciences Patent Attorney, Patent Prosecution Attorney, Patent Attorney New York, New York legal jobs, Attorney jobs NYC, USPTO registered patent attorney, Law firm patent associate, Partner-track position, lawyer,Biotech patent,pharma patent,life sciences IP,medical device patent,patent prosecution - biotech,USPTO - biology,patent agent - life sciences


A leading intellectual property practice is seeking a Life Sciences Patent Associate Attorney (3+ years experience) to join its growing patent prosecution team in New York, New York. Work with innovative biotechnology and life sciences companies on complex patent portfolio strategy and prosecution.


This law firm was founded over 40 years ago to provide legal services for technology, clean tech sectors, and life sciences companies that are making world-changing innovations. They specialize in offering fast service to keep up with the rapid changes in the technology industry. Their areas of practice include intellectual property, litigation, corporate, and electronic information management. This firm has offices in California, Washington, New York, and Shanghai.


________________________________________


A prominent intellectual property law practice is seeking a Life Sciences Patent Associate Attorney to join its expanding patent prosecution group in New York, New York. This role focuses on biotechnology and life sciences innovations, supporting cutting-edge companies developing breakthroughs in molecular biology, genetics, cellular technologies, and biotechnology.



Attorneys pursuing New York legal jobs in intellectual property will gain the opportunity to work with emerging technology and life sciences companies while managing sophisticated patent portfolios. The Patent Attorney will assist clients in protecting their intellectual property through strategic patent drafting, prosecution, and counseling.


This partner-track position provides exposure to high-growth industries including biotechnology, medtech, and AI-enabled medical innovations. The role offers hands-on involvement with patent strategy, portfolio development, and intellectual property due diligence in corporate transactions.


This opportunity is actively interviewing candidates seeking advanced New York legal jobs within biotechnology patent law and intellectual property strategy.

________________________________________


Key Responsibilities


• Manage client relationships and oversee life sciences patent portfolios.

• Draft and prosecute patent applications involving biotechnology, molecular biology, genetics, and cellular technologies.

• Conduct prior art searches and patentability analyses.

• Perform freedom-to-operate analyses for emerging technologies.

• Draft responses to USPTO office actions and manage prosecution strategies.

• Provide intellectual property counseling to biotechnology and life sciences clients.

• Conduct IP due diligence for corporate transactions, financings, and strategic investments.

• Support patent litigation teams with technical analysis when needed.

• Participate in post-grant proceedings before the United States Patent and Trademark Office.

• Mentor junior patent agents and attorneys within the practice.

________________________________________


Qualifications


• 3+ years of experience as a Patent Associate Attorney within a law firm intellectual property practice.

• Ph.D. or M.S. in a life sciences discipline, such as Molecular Biology, Genetics, Biochemistry, Immunology, Bioengineering, or related field.

• USPTO registration required as a patent practitioner.

• Experience drafting and prosecuting life sciences patent applications.

• Strong scientific understanding of biotechnology and related research fields.

• Ability to collaborate with scientists, inventors, and business teams.

• Excellent legal writing and technical communication skills.

________________________________________


Education


• Juris Doctor (JD) degree required.

• Ph.D. or M.S. in Cellular & Molecular Biology, Genetics, Biochemistry, Bioengineering, or related field.

________________________________________


Certifications


• Registered with the United States Patent and Trademark Office (USPTO).

________________________________________


Skills


• Strong analytical and research capabilities.

• Advanced patent drafting and prosecution skills.

• Excellent written and verbal communication abilities.

• Strong client management and relationship-building skills.

• Leadership ability to mentor junior patent professionals.

________________________________________


Culture & Firm Appeal


This opportunity is with a well-established intellectual property law firm that focuses on supporting innovative companies across technology, clean technology, and life sciences industries. The firm works with organizations developing transformative technologies and provides legal strategies that help protect and commercialize cutting-edge scientific advancements.

Attorneys benefit from a collaborative and fast-paced environment where legal professionals work closely with inventors, scientists, and technology leaders. The firm emphasizes responsive service, deep technical expertise, and strong client relationships.

Professionals exploring New York legal jobs in intellectual property law will appreciate the firm’s strong reputation within the innovation ecosystem and its commitment to supporting groundbreaking technology companies.

________________________________________


Why This Role Is Unique


• Opportunity to work with biotechnology and life sciences innovators developing breakthrough technologies.

• Exposure to cutting-edge fields including genetics, molecular biology, medtech, and biotechnology.

• Direct involvement in patent portfolio strategy and IP due diligence for corporate transactions.

• Collaborative environment with scientists, inventors, and technology entrepreneurs.

• Clear partner-track position offering long-term career growth.

• Ideal opportunity for attorneys pursuing advanced New York legal jobs in biotechnology patent law.

This position rarely opens at this level and offers the chance to build a specialized practice at the intersection of law, science, and innovation.

________________________________________


Benefits


• Healthcare and Life Insurance.

• Health Savings Accounts and Flexible Spending Accounts.

• Wellbeing programs.

________________________________________


Call to Action


Apply now for a confidential discussion with a BCG Attorney Search recruiter.

Explore this elite-level opportunity today.

Submit your resume to learn more about this prestigious role.

________________________________________


BCG Attorney Search is the industry leader for placing candidates in permanent positions in law firms. Since 2000, our recruiters have placed several thousand attorneys and enjoyed extraordinarily high success rates with our candidates. As a BCG Attorney Search candidate, you have access to more opportunities than any legal placement firm in the United States. We are able to offer the most in-depth insight in the legal recruiting market thanks to our dedicated team of over 150 employees who mercilessly research, study and analyze the legal market. The depth and breadth of our research empowers us to place attorneys at rates that are unparalleled at any placement firm in the United States. Many of our recruiters make 30 to 40 placements per year, while recruiters at competitor firms are likely to make four or five. Unlike other placement firms that can only tell you about openings at major AmLaw firms, we place candidates of all backgrounds in firms of all sizes. While other legal recruiters only represent a narrow band of candidates from top law firms and top law schools, our research, firm contacts, and market insight allow us to place hundreds of candidates each year who do not fit this mold. It is rare that we do not get candidates we represent interviews and offers. No one in the world is better at legal recruiting and placement than BCG Attorney Search.


BCG Attorney Search will confidentially review your application and will not forward your materials to the firm without first discussing the opportunity with you.

Not Specified
Director Process Development and Manufacturing, CMC
Salary not disclosed
Durham, NC 2 days ago

Job Title: Director Process Development and Manufacturing, CMC

Department: CMC

Reports to: Chief Technical Officer


About the Company:  

Opus Genetics is committed to building an innovative, efficient and sustainable science based and commercial ophthalmic biopharmaceutical company leading the development of transformative gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies to treat patients with other retinal and refractive disorders.


Job Summary: 

The Director of Process Development and Manufacturing will be the technical lead for development and manufacturing of assigned assets within the Opus gene therapy programs focusing on technical transfer and process development and execution supporting product development and manufacturing to achieve company goals and strategies. This includes working collaboratively with external partners (i.e. CDMOs, contract labs, suppliers) to develop technical studies, analyze complex data, make data driven decisions, and author, review, and approve technical and regulatory documents. The ideal candidate will have a deep technical understanding of AAV gene therapy upstream and downstream development and process optimization.  This role will directly interact with the CDMO/contract partners and be responsible for building and maintaining excellent working relationships. Knowledge of manufacturing platforms, consistent with AAV technology, at scales ranging from process development through GMP and PPQ activities. The candidate will be hands-on and expected to provide content to all these areas. 

Duties/Responsibilities: 

·      Work with Opus CDMO/contract manufacturing and laboratory partners to develop a phase appropriate robust manufacturing program to support the process development and engineering of pre commercial and commercial cGMP material to support pre-clinical studies, clinical trials, and commercial supply. 

·      Support, author, and review/approve manufacturing plans and documentation including technical transfer, batch records and documentation, product specifications, stability programs, bridging and comparability studies, and other reports utilizing phase appropriate QbD best practices.

·      Support, author, and review/approve manufacturing documentation including testing records, certificates of testing/analysis, campaign summary reports, investigations, etc. 

·      Support, author, and review/approve regulatory documentation including pINDs, INDs, agency responses, CMC meeting requests and briefing packages, and BLAs.   

·      Ensure proper reference standard material is in place, tested, and released for each product. Lead technology transfer between sites. 

·      Ensure regulatory requirements are in place to support manufacturing campaigns with respect to Master Cell Banks, Plasmids, Drug Substances, Drug Products, and Diluents, to prevent developmental delays and or interruptions to clinical programs or regulatory filings.

·      Perform the role of person in plant as needed at the Opus CDMO/contract manufacturing partner’s sites. Act as the CMC expert during audits and interactions with regulatory agencies. 

·      Manage work to project plans for multiple gene therapy programs in the preclinical, pre-IND, IND/clinical, and commercial stages. 

·      Identify and lead the resolution of operational and functional level challenges, work with program and/or function managers to escalate issues to senior management.

·       Hands on resolution to issues/content generation. Design effective and high-quality presentations and progress reports, as requested.

  

Supervisory Responsibilities: 

·      None 

 

Education and Experience: 

·      Master’s degree (minimum) from an accredited institution in a science or health-related field with minimum of 7-10 years of experience in the pharmaceutical or biotechnology industry. Ophthalmology experience is preferred.

·      Additionally, a minimum of 5 years of direct manufacturing experience for biopharmaceuticals. Preference will be given for direct AAV gene therapy experience. Previous CDMO/contract lab experience also preferred.

·      Experience designing and executing technical transfer and scale up campaigns and associated documentation.

·      Experience in writing and reviewing regulatory submissions including pINDs, INDs, Meeting Requests/Briefing Packages, Annual Report/DSUR’s, and BLAs. 

·      Experience with FDA and/or other regulatory agency requirements and interactions.

·      Strong skill set in interacting with multidisciplinary teams for preclinical and clinical development. Clear understanding of the drug development process with experience in multiple phases.

·      Experience with Orphan/Rare Disease programs, and/or Fast Track/Breakthrough Therapy is a plus.

·      Demonstrated leadership skills and ability to influence across all levels of a cross-functional team without direct managerial authority. Experience in risk assessment, negotiation, and problem solving/mitigation.

·      Outstanding interpersonal skills, ability to communicate effectively in both oral and written form, with effective time management skills needed to manage multiple ongoing projects simultaneously.

·      Demonstrated advanced computer software proficiency (Word, Excel, Smartsheet’s, PowerPoint, etc.).  

Physical Requirements:  

·      Ability to travel 20% of time

·      Ability to work in laboratory settings/situations

·      Prolonged periods sitting at a desk and working on a computer. 

·      Must be able to lift up to 15 pounds at times. 

 

 

Location:

This position is currently based in the Durham North Carolina area; Hybrid/ remote options considered.

 

 Salary Range:


$190,000-210,000



The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. 

 

Opus Genetics is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. 

 

Not Specified
MES (PAS-X) Lead Engineer
✦ New
Salary not disclosed
Wilson, NC 1 day ago

MES (PAS-X) Lead Engineer (Biotech/Pharmaceutical)

Location – Wilson, NC


Aztec Technologies is an engineering and consulting firm providing expertise in the

pharmaceutical and biotechnology industries. Aztec Technologies and Aztec Process Automation

are part of Trinity Consultants Company.


Trinity Consultants, Inc., a leading international EHS, life sciences and environment consulting

services with 1500+ engineers worldwide.


Aztec Technologies provides solutions for Manufacturing Applications:

• Process and Facility Automation

• Project Management

• MES

• Data Analytics


With offices across 3 continents, consulting firm with over 20 years of experience within the

biopharmaceutical and pharmaceuticals industries.


The successful candidate will work with a group of engineers involved in the design, automation,

commissioning and start-up of various processes, systems, and facilities. A combination of

strong technical aptitude, automation engineering skills and technical writing are the desired skill

set. This is an outstanding opportunity to join our growing team and to work in the Life Sciences

space that will enhance professional opportunities!


Candidates need to be local or willing to relocate to the areas of operation where we have open

opportunities for immediate hire in the Wilson, NC area:


Key Responsibilities:

  • Own MES configuration management for PAS-X, including:
  • Manufacturing Batch Records (MBRs)
  • Material management
  • Equipment and timer management
  • Label management
  • Lead MES design, configuration, testing, and troubleshooting
  • Act as technical interface between MES, DCS (DeltaV), ERP, LIMS, and other shop-floor systems
  • Support MBR migration from a legacy site
  • Ensure alignment with site and global MES standards
  • Support risk assessments and GMP compliance activities
  • Provide hands-on troubleshooting and technical support during execution
  • Develop and maintain MES technical documentation
  • Collaborate closely with IT, Manufacturing, Quality, and Engineering teams


Required Qualifications

  • 8+ years experience in pharmaceutical or biopharmaceutical manufacturing environments
  • Strong hands-on experience with MES platforms, preferably Werum PAS-X
  • Proven experience with MBR design and execution
  • Solid understanding of GMP manufacturing processes
  • Experience integrating MES with DCS (DeltaV) and enterprise systems
  • Strong analytical, troubleshooting, and problem-solving skills
  • Bachelor’s degree in Engineering, IT, Science, or related discipline


Preferred / Nice-to-Have Skills

  • Programming experience: .NET, SQL / PL-SQL, Java
  • Experience with OPC servers/clients
  • Knowledge of 21 CFR Part 11 and EU GMP Annex 11
  • Process knowledge across:
  • Upstream
  • Downstream
  • Bioprocess support functions
  • Ability to communicate effectively with both technical and non-technical stakeholders


Ideal Candidate Profile:

  • Senior-level PAS-X MES SME
  • Strong on-site presence and ownership mindset
  • Comfortable operating as Owner’s Rep, not a junior configurator
  • Deep pharma/biotech automation background
  • Able to bridge Manufacturing, IT, Automation, and Quality
Not Specified
Sr Research Associate
Salary not disclosed
Novato, CA 2 days ago

Are you an experienced Sr Research Associate with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Sr Research Associate to work in Novato, CA.


Position Summary: The selected candidate will work in the Separations and Biophysical Assays team within the Analytical Sciences group to assist in the advancement of clients' therapeutics for clinical evaluation and potential commercialisation. The candidate will be responsible for method development (separations), provide routine testing and characterization support to partner groups to help with early candidate selection, process development, and drug substance and drug product process characterization. The ideal candidate will have hands-on experience working with biologics including but not limited to proteins, peptides, protein-conjugates, enzymes, biologics with a focus on method development and in-depth characterization. The ideal candidate will be able to perform quality work under limited supervision, apply problem solving techniques to maintain accurate results, promote improvements, and assure a safe, stable, on-target operation within the laboratory. The selected candidate should possess excellent analytical, organizational and communication skills and be a self-starter willing to work efficiently and collaboratively in a dynamic environment. This role is primarily a laboratory position; contact with chemicals is part of the job. The role is fully onsite (5 days a week, 8-hour days) with occasional evening or weekend work required. The employee will be trained to use common lab equipment and minimize exposure to hazards. Desktop or laptop computer work is also a major component of the job. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, knee crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities in this job include close vision, depth perception and ability to adjust focus.


Primary Responsibilities/Accountabilities:

  • Primary responsibility is to support the Separations and Biophysics group within Analytical Sciences
  • Be a hands-on presence in the laboratory, supporting biophysical/ biochemical assay development and qualification using HPLC and CE (must have) for various modalities (preferably biologics). LC-MS (high-res) experience is also desirable.
  • Provide routine analytical characterization & testing support to partner groups including Upstream and Downstream PD, Formulations, and Research & Early Development (RED).
  • Document experimental results in the company electronic lab notebook (Benchling), author procedures, and contribute to technical documentation (test methods, development reports).
  • Actively participate in the operational aspects of the laboratory by conducting safety inspections, lab organization, ordering supplies, and performing routine equipment maintenance.
  • Present scientific literature and results from ongoing studies at group meetings and other discussion forums at the company.
  • Other duties as assigned.


Qualifications:

  • Bachelor's degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering or a related field with 6+ years of experience in a Biologics or Pharmaceutical environment.
  • Master's degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering or a related field with 4+ years of experience in a Biologics or Pharmaceutical environment.
  • Hands-on experience in the biotechnology industry or academic setting with a broad range of analytical techniques focused on analytical testing and characterization for proteins, peptides, and protein-conjugates is required.
  • Experience with biochemical characterization methods is required:
  • SEC, SCX, RP-HPLC experience is a must (Agilent/Waters/Thermo LC instruments)
  • Capillary Electrophoresis (PA800 or BioPhase8800) based methods (SDS for size separation, glycan profiling)
  • cIEF (Maurice) experience is highly desirable
  • LC-MS (Orbitrap/QToF/QQQ) method development experience also desirable
  • Technical understanding of all aspects of analytical testing, phase appropriate regulatory requirements, method qualifications, and method transfers.
  • Ability to independently troubleshoot issues, ideate, and develop insights into technical challenges and propose solutions to solve them.
  • Demonstrates attention-to-detail and "right-the-first time' approach
  • Excellent written and oral communication skills, with the ability to communicate complex information. Be able to present data/ideas to functional and cross-functional teams.
  • Ability to influence others effectively and develop collaborative relationships with partner teams.
  • Familiar with use of statistical software, electronic document management, and laboratory information management.
  • Ability to effectively analyze complex problems and present results effectively within and beyond the department
  • Ability to flexibly adapt to changing business needs and meet timelines.
  • Strong organizational skills with the ability to effectively multi-task and prioritize.


Preferred:

  • Experience in method development, qualification, and transfer to/from other laboratories, such as development and quality control.
  • Knowledge of biopharmaceutical process development is a plus.
  • Experience with automation is a plus.
  • Experience working in a cross-functional environment.
  • Good understanding of root cause analysis methodology.
Not Specified
Instructor Pool - Biology, Chemistry, and Physics - UC Berkeley Extension
✦ New
🏢 University of California-Berkeley
Salary not disclosed
San Francisco, CA 1 day ago
Position overview

Position title:
Instructor (Non-Senate, Non-Tenure Track)

Salary range:
The compensation model varies depending upon the course delivery format. For a synchronous Classroom (In-Person) or Live Online course, a reasonable estimate for this position is $2,750 - $6,800 total per course. For an asynchronous Start Anytime Online course, this position is paid $180 - $200 per final student course grade submitted each month; a reasonable estimate ranges from $900 - $20,000 total per course; and monthly payments typically begin within 6 months after the course start date. Instructor compensation is determined by course length, number of units, enrollment, budgetary considerations, and other factors.

Percent time:
Part-time by agreement on a course-by-course basis.

Anticipated start:
Some appointments may begin as early as the spring semester.

Review timeline:
Applicants are considered for positions as needs arise; the existence of this applicant pool does not guarantee that a position is available. The applicant pool will remain in place for 9-12 months; those interested in remaining in the applicant pool beyond the advertised final closing date must reapply.

Position duration:
Length of courses differs depending on the subject, level, format/schedule, and credits taught. For the fall/spring semesters, course length typically ranges from approximately 9 to 18 weeks. For the summer semester, course length typically ranges from approximately 7 to 9 weeks. For asynchronous online start anytime courses, agreement length typically ranges from 6-18 months. Further course agreements may be assigned based upon program needs, meritorious performance, and funding availability.

Application Window


Open date: October 6, 2025




Next review date: Monday, Mar 23, 2026 at 11:59pm (Pacific Time)

Apply by this date to ensure full consideration by the committee.




Final date: Monday, Oct 5, 2026 at 11:59pm (Pacific Time)

Applications will continue to be accepted until this date, but those received after the review date will only be considered if the position has not yet been filled.



Position description

UC Berkeley Extension (UNEX), the continuing education branch of the University of California, Berkeley, has been building bridges between UC Berkeley and the public since 1891. UNEX serves the professional and continuing education goals of thousands of people each year and plays an essential part of the University mission to: extend the research and scholarship of UC Berkeley to a global community; increase access to higher education for non-traditional, online, and international students; and improve the workforce. UC Berkeley Extension is a part of the division under the leadership of the Dean of Extended Education that also includes Berkeley Summer Sessions, Berkeley Study Abroad, and Osher Lifelong Learning Institute.



UC Berkeley Extension invites applications for a pool of qualified, dynamic instructors with a commitment to undergraduate, professional, and continuing education in Biology, Chemistry, and Physics to teach one or more in-person and/or online courses each year for our Sciences, Mathematics, Biotechnology, and Health Sciences departments.



Courses are offered in-person and online.




  • Classroom instruction takes place in the San Francisco Bay Area (California, U.S.A.), including Alameda County and San Francisco County.
  • Online instruction is delivered asynchronously through our learning management system (Canvas) or through synchronous live lectures (Zoom).


Most classroom and synchronous live online lecture courses are offered in the evening and on the weekend (U.S.A. Pacific Time).



Course Subjects

We are seeking qualified applicants who possess current subject matter expertise and/or teaching knowledge in (but not limited to) the following course subjects. For a complete list of courses and course descriptions, please refer to the departmental links below.



Biology




  • General Biology I lecture and lab (cell structure + function, prokaryotes, eukaryotes, metabolism, molecular genetics, classification, animal development, form + function)
  • Introductory Biology With Lab
  • General Biology II lecture and lab (fungi + plant development, population genetics, ecology, conservation, origin of life, evolution, classification)
  • Biochemistry
  • Biology of Aging
  • Biology of Human Cancer
  • Biostatistics
  • Cell Biology
  • Current Topics in the Biosciences
  • Developmental Biology
  • Endocrinology
  • Epidemiology
  • Genetics
  • Genomic or Personalized Medicine
  • Hematology
  • Human Anatomy/Neuroanatomy lecture and lab
  • Human Nutrition
  • Immunology
  • Kinesiology (Introduction to Kinesiology, Mechanical Kinesiology)
  • Medical Terminology
  • Microbiology/Infectious Disease (Microbiology lab, Medical Microbiology lecture, Principles of Infectious Disease lecture)
  • Molecular Biology
  • Neuroscience
  • Parasitology
  • Pathophysiology
  • Pharmacology
  • Physiology (Lecture/Lab: general human, Lecture Only: mammalian + systemic, cardiac + respiratory, exercise)
  • Stem Cell Biology
  • Toxicology
  • Virology


Chemistry




  • Chemistry for the Health Sciences
  • General/Inorganic Chemistry I lecture and lab
  • General/Inorganic Chemistry II lecture and lab
  • Introduction to Chemistry
  • Introduction to Organic Chemistry
  • Organic Chemistry I lecture and lab
  • Organic Chemistry II lecture and lab
  • Quantitative Analysis: Applications in Clinical Chemistry


Physics




  • Concepts of Physics
  • General Physics I lecture and lab
  • General Physics II lecture and lab


Other Science Subjects or Courses

(please specify on your Instructor Information Form)



Teaching Experience




  • Classroom Teaching Experience
  • Synchronous Online Teaching Experience (online lectures via Zoom)
  • Asynchronous Online Teaching Experience (via learning management system)


General Duties

The department seeks candidates who can support the success of all students through inclusive curriculum, classroom environment, and pedagogy. Specific duties and expectations will vary depending on the method of instruction including: Classroom (In-Person); Synchronous Live Online (Zoom); or Asynchronous Online (Start Anytime).




  • For synchronous instruction (classroom or live online courses), duties include but are not limited to: syllabus development; assignment development; lesson planning for class meetings; preparing and submitting required texts and course materials; reviewing and updating Canvas course site; and delivering lectures, presentations, and learning activities for all required hours of instruction.
  • For asynchronous instruction (start anytime online courses), duties include but are not limited to: reviewing the syllabus and pre-populated online course content; learning and utilizing Canvas classroom management tools; and requesting any training needs from the Program Director or Department Director.
  • For all instruction (regardless of course format) duties include but are not limited to: completing required trainings as mandated by the UC Presidential policies; responding to student questions and learning needs in a timely manner; grading student assignments and posting final student grades to the instructor portal in a timely manner; utilizing University-approved course support platforms including the Canvas Learning Management System, Zoom, Instructor Portal, Google Workspace, etc.; reviewing and following University and departmental policies, logistics, and other guidelines as published on the departmental Instructional Resource Site; and responding to other requests from the Program Director or Department Director in a timely manner.


Biology Course Descriptions: academic-areas/sciences-mathematics-and-biotechnology/?nav=1#!?tab=courses&programStream=Biology

Chemistry and Physics Course Descriptions: academic-areas/sciences-mathematics-and-biotechnology/?nav=2#!?tab=courses&programStream=Chemistry%20and%20Physics

Clinical Laboratory Science Course Descriptions: academic-areas/sciences-and-biotechnology/#!?programStream=Clinical%20Laboratory%20Science



Qualifications

Basic qualifications (required at time of application)

  • Doctorate degree or equivalent international degree.


Additional qualifications (required at time of start)


  • U.S.A. Residency and U.S.A. Work Authorization: All work must be performed in the United States, whether in person or online. For applicants who are not US citizens or permanent residents, a valid US work authorization is required for the duration of employment. Applicants should not expect the department to sponsor a work visa on their behalf.


Preferred qualifications

  • Doctorate degree or equivalent international degree in course subject or related area.
  • 3 or more years of professional or undergraduate-level teaching experience (as the primary instructor) in the course subject.
  • Experience teaching at a U.S. college/university institution.
  • Experience teaching and/or developing academic content for online courses.
  • Experience in creating syllabi, learning objectives, lectures/presentations, learning activities, assignments, assessments, exams, and quizzes.
  • Ability to convey conceptual and complex ideas and information.
  • Ability to support the success of all students through inclusive curriculum, classroom environment, and pedagogy.
  • Effective verbal/written communication and presentation skills (English).
  • Effective organizational skills with attention to detail.
  • Ability to collaborate with colleagues and work within a team environment.
  • Proficiency in (or willingness to learn) instructional and other technology, such as: Learning Management Systems (Canvas); lecture/presentation capture applications (Panopto); online video conferencing (Zoom); Microsoft Office (Word and PowerPoint); file sharing (Google drive or Dropbox); and Google Workspace tools (email, calendar, docs, sheets, slides, etc).


Application Requirements

Document requirements

  • Curriculum Vitae - Your most recently updated C.V.


  • Cover Letter


  • Instructor Information Form - Download the Instructor Information Form PDF to your computer desktop. Open the document using the Adobe Acrobat application. It is not recommended to use an internet PDF viewer or Google Docs to complete this form. Complete all six (6) pages, save, and upload the PDF form to your AP Recruit application.




Reference requirements

  • References are requested from candidates at the interviewing stage, and references are only contacted for finalists.


Apply link:
JPF04687

Help contact:



About UC Berkeley

UC Berkeley is committed to diversity, equity, inclusion, and belonging in our public mission of research, teaching, and service, consistent with UC Regents Policy 4400 and University of California Academic Personnel policy (APM 210 1-d). These values are embedded in our Principles of Community, which reflect our passion for critical inquiry, debate, discovery and innovation, and our deep commitment to contributing to a better world. Every member of the UC Berkeley community has a role in sustaining a safe, caring and humane environment in which these values can thrive.



The University of California, Berkeley is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or protected veteran status.



For more information, please refer to the University of California's Affirmative Action and Nondiscrimination in Employment Policy and the University of California's Anti-Discrimination Policy.



In searches when letters of reference are required all letters will be treated as confidential per University of California policy and California state law. Please refer potential referees, including when letters are provided via a third party (i.e., dossier service or career center), to the UC Berkeley statement of confidentiality prior to submitting their letter.



As a University employee, you will be required to comply with all applicable University policies and/or collective bargaining agreements, as may be amended from time to time. Federal, state, or local government directives may impose additional requirements.


Unless stated otherwise, unambiguously, in the position description, this position does not include sponsorship of a new consular H-1B visa petition that would require payment of the $100,000 supplemental fee.



As a condition of employment, the finalist will be required to disclose if they are subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct.




  • "Misconduct" means any violation of the policies or laws governing conduct at the applicant's previous place of employment, including, but not limited to, violations of policies or laws prohibiting sexual harassment, sexual assault, or other forms of harassment or discrimination, as defined by the employer.
  • UC Sexual Violence and Sexual Harassment Policy
  • UC Anti-Discrimination Policy
  • APM - 035: Affirmative Action and Nondiscrimination in Employment


Job location
San Francisco Bay Area, California, U.S.A.
Not Specified
Corporate Paralegal
✦ New
Salary not disclosed

Company Description

ZEO ScientifiX™, based in South Florida, is a publicly traded biotechnology company specializing in research, development, and manufacturing of innovative biologic medicines. As a leader in regenerative therapeutics, our company is on a mission to transform medicine with cutting-edge nano-technologies. ZEO ScientifiX™ is dedicated to driving advancements in health care and fostering the next generation of biologic medicine development. Our commitment to innovation and excellence positions us at the forefront of the biotechnology industry.


Role Description

ZEO ScientifiX™ is seeking a full-time Corporate Paralegal to join our team in Fort Lauderdale, FL.

The successful candidate will support corporate legal operations with a strong focus on FDA regulatory compliance, corporate governance, and contract management. This role requires a detail-oriented professional capable of managing legal documentation, supporting regulatory submissions, and ensuring adherence to federal and state regulatory frameworks applicable to biotechnology and biologic products.


Key Responsibilities

  • Assist with preparation, review, and management of corporate legal documents, contracts, and agreements
  • Support compliance initiatives related to the U.S. Food and Drug Administration (FDA), including regulatory filings, correspondence, and documentation
  • Monitor and track FDA regulatory requirements, guidance updates, and submission deadlines
  • Conduct legal and regulatory research related to biotechnology, biologics, and healthcare regulations
  • Maintain and organize corporate records, regulatory files, and governance documentation
  • Assist with preparation for audits, inspections, and responses to regulatory inquiries
  • Facilitate communication between internal departments, executive leadership, and external counsel
  • Support corporate governance matters, including board documentation and public company compliance requirements
  • Ensure strict confidentiality and proper handling of sensitive corporate and regulatory information


Qualifications

  • Demonstrated knowledge and experience with FDA regulations and compliance requirements
  • Experience in corporate law and legal document preparation
  • Strong expertise in document review, contract analysis, and legal research
  • Excellent written and verbal communication skills
  • Exceptional organizational skills and attention to detail
  • Ability to manage confidential and sensitive information with discretion
  • Proficiency in legal research tools and document management systems (preferred)
  • Bachelor’s degree in Paralegal Studies, Legal Studies, or a related field
Not Specified
Consulting Lead
$250 +
Mission, KS 4 days ago
Overview

OPEN TO FTC (1 YEAR) OR PERMANENT ROLES. We are seeking a Consulting Lead with experience in strategy, transformation or advisory consulting (for example from a Big4 or strategy consulting background) to help design and deliver complex programmes, operating models and strategic initiatives for our clients.

The role focuses on providing practical consulting support to organisations tackling complex strategic, operational and innovation challenges. This includes helping organisations define strategy, design effective operating models, deliver transformation programmes and strengthen governance and delivery structures.

A key part of the role will involve working at the intersection of innovation and policy, helping organisations understand and harness emerging and frontier technologies such as AI, cyber, quantum, biotechnology and advanced digital capabilities.

The successful candidate will be able to structure complex problems, analyse evidence and develop clear, practical recommendations for senior stakeholders. The role involves working across multiple engagements, supporting strategy development, programme design, business case development, organisational change and delivery oversight.

You will work closely with senior stakeholders across industry, government and academia to shape programmes, improve delivery approaches and support the successful implementation of complex initiatives, particularly those focused on innovation ecosystems and the adoption of frontier technologies.

More broadly, the Consulting Lead will contribute to Plexal’s wider consulting and innovation activity, helping translate emerging technology opportunities into well-structured programmes, initiatives and investment propositions.

Plexal is a rapidly growing organisation and we are looking for individuals who enjoy working in a fast-paced, collaborative environment, engaging with cutting-edge technology sectors and solving complex strategic problems.

What You'll Do
  • Strategic Advisory: Provide strategic advice on complex programmes, organisational challenges and transformation initiatives.
  • Problem Structuring: Analyse complex issues and develop clear, evidence-based recommendations for senior stakeholders.
  • Business Cases: Develop business cases and investment propositions to support strategic and programme decisions.
  • Operating Models: Design and implement operating models, including governance, roles and delivery structures.
  • Transformation Delivery: Support the planning and delivery of transformation programmes and major initiatives.
  • Programme Governance & Assurance: Establish or strengthen programme governance, PMO structures and delivery assurance.
  • Stakeholder Engagement: Work with senior stakeholders across government, industry and academia to shape programmes and delivery approaches.
  • Consulting Delivery: Lead work streams, produce high-quality consulting outputs and support the development of new opportunities.
Your Skills
  • Consulting Experience: Experience working in consulting, advisory or complex programme environments (e.g. strategy consulting, Big4 or public sector advisory).
  • Strategy & Transformation: Experience supporting strategy development, transformation programmes or complex organisational change.
  • Problem Solving & Analysis: Ability to structure complex problems, analyse information and develop clear, evidence-based recommendations.
  • Programme Delivery: Experience supporting or delivering large programmes or transformation initiatives, including PMO or programme governance.
  • Business Cases: Experience developing business cases or investment propositions to support strategic decisions.
  • Stakeholder Management: Ability to work effectively with senior stakeholders across organisations.
  • Communication & Delivery: Strong written communication skills and the ability to manage multiple work streams in fast-paced environments.
Domain Experience (Desirable)

Experience working within or supporting organisations operating in one or more of the following areas:

  • Emerging Technology & Innovation: Experience working within innovation ecosystems or technology-driven environments, particularly across emerging or frontier technologies such as AI, cyber, quantum, biotechnology or advanced digital capabilities.
  • Public Safety: Public safety or emergency services organisations.
  • Policing: Policing or law enforcement environments.
  • Home Affairs: Home affairs, homeland security or border-related organisations.
  • Defence: Defence or national security environments.
Qualifications: Essential
  • Higher Education degree, or equivalent knowledge gained via work experience.
Who You Are
  • Interest in innovation, technology and emerging sectors (e.g. AI, cyber, quantum, biotechnology, IoT)
  • Comfortable working in a collaborative consulting environment with changing priorities
  • Strong problem-solving mindset and ability to work through ambiguity
  • Resilient and able to remain focused while managing complex programmes and challenges
  • Strong interpersonal and collaboration skills when working across teams and stakeholders
  • This role may require some national travel for delivery of projects and travel to all Plexal sites.
  • Due to the nature of this position, our work, and our client engagements, you must be willing and eligible to achieve a minimum of SC clearance and ideally already hold this clearance. To qualify for SC clearance, you must be a British Citizen or have resided in the UK for the last 5 years with no extensive periods outside of the UK. For more information about clearance eligibility, please see us?

    Plexal’s Values:

    Mission: We inherit the mission of UK government and deliver it in an agile and creative fashion.
    Collaboration: We believe in the power of working together.
    Equality: We strengthen ourselves as a team by embracing the different.
    Care: People are at the heart of what we do; we care about our customers, members and colleagues.

    As a start-up, we thrive in a dynamic and fast-paced work environment dedicated to empowering innovators. We embrace individuals who leverage technology and creativity to tackle our greatest challenges head-on. We strongly advocate for maintaining a harmonious work-life balance, our goal is to ensure every member of our team can authentically be themselves and live their best lives. We firmly believe that innovation and creativity flourish when we cultivate a diverse workforce, comprising highly skilled individuals with a wide range of perspectives to contribute.

    In return we will offer you:

    • Salary: £65,000 - £80,000 depending on skills and experience
    • Annual bonus scheme
    • A generous pension scheme (with a company contribution of up to 10%)
    • Private healthcare, life assurance and critical illness cover
    • 25 days holiday plus bank holidays
    • Volunteering day

    Plexal is an equal opportunities employer and we actively encourage applicants from individuals from all backgrounds. We are a Disability Committed employer and are willing to make reasonable adjustments throughout the recruitment process.


    #J-18808-Ljbffr
Not Specified
Data Reviewer, QC
Salary not disclosed
Hopewell, NJ 2 days ago

Essential Functions of the job:

  • Review and validate QC data and test records.
  • Support investigations related to Out of Specification (OOS), Out of Trend (OOT), and Out of Expectation (OOE) results.
  • Ensure compliance with current Good Manufacturing Practices (cGMP) in the laboratory.
  • Assist in the technical documentation of investigations and change control assessments to evaluate the impact on product quality, in alignment with FDA/EU regulations, international standards
  • Undertake other duties as required.

This position is ideal for candidates who are detail-oriented and committed to quality assurance in the pharmaceutical industry.

Education/Experience Required:

  • Bachelor’s Degree or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline. Scientific degree (ideally chemistry, biochemistry, biotechnology or related).
  • Minimum 4 years working experience in an FDA-regulated biotechnology or pharmaceutical company is required.
  • Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, Capillary Electrophoresis (CGE-Reduced, CGE-Non-Reduced, and Capillary Zone Electrophoresis), etc.
  • Strong working knowledge with USP/EP and cGMP/EU GMP.
  • Technical writing experience.
  • Familiar with instrument and equipment validation.
  • Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
  • Credible and confident communicator (written and verbal) at all levels.
  • Strong analytical and problem-solving ability.
  • Hands-on approach, with a ‘can do’ attitude.
  • Ability to prioritize, demonstrating good time management skills.
  • Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
  • Self-motivated, with the ability to work proactively using own initiative.
  • Committed to learning and development
  • Self-motivated, with the ability to work proactively using own initiative.

Computer Skills:

  • Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Travel:

  • Must be willing to travel approximately 10%.
  • Ability to work on a computer for extended periods of time.
Not Specified
Manufacturing Associate I (DS)
✦ New
Salary not disclosed
Chicago, IL 1 day ago

Position Summary:

  • The Manufacturing Associate I (DS), will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use.
  • Employee applies aseptic techniques while working in controlled and classified environments, which require cleanroom gowning and some aseptic gowning.
  • Must comply with Client policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement.

Essential Duties & Responsibilities

  • Follow work instructions, production specifications, and standard operating procedures (SOPs) to perform key responsibilities and maintain quality data while meeting production goals and timelines and minimizing downtime/delays.

Work instructions include but are not limited to:

  • Weighing and dispensing of materials
  • Media and buffer preparation
  • Operation of filtration systems (such as dead end filtration, depth filtration, tangential flow filtration)
  • Inoculation, fermentation, harvest, and homogenization of cytokine cells
  • Setup and operation of chromatography columns
  • Aseptic final filtration of intermediates and drug substances
  • Monitor product for quality output using PLC controls, HMI interfacing, integrity testing, and in process testing (pH, Conductivity, and Spectroscopy).
  • Properly handle and discard hazardous materials (i.e, buffers, chemicals, etc.) in accordance with EHS guidelines. Remove used and soiled materials from manufacturing areas.
  • Follow daily and weekly cleaning routines for cleanrooms and equipment to maintain the required conditions for cleanroom manufacturing.
  • Verify raw materials and commodities; accurately enter raw material and commodities data in MES on daily basis
  • Completes Batch Records and other cGMP documentation accurately and in a timely manner.
  • Reports nonconformances or events that arise during the shift to the Supervisor
  • Complies with all safety, cGMP and Company policies, practices and procedures.
  • Performs other functions as required or assigned

Position Requirements and Qualifications

Education:

  • Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred
  • Or an equivalent of 0 – 2 years of industry experience required
  • Aseptic techniques and cleanroom manufacturing experience is preferred.

Special Skills

Language:

  • Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English.
  • Excellent interpersonal skills, effective communication with peers and supervision.
  • Reasoning Skills:
  • The candidate should have the ability to operate complex systems and equipment in accordance with current GMPs, SOPs, and safety guidelines under minimum supervision.
  • Basic skills for identifying problems and troubleshooting of the equipment and manufacturing processes
  • Ability to work independently, within prescribed guidelines, or as a team member and the demonstrated ability to follow detailed directions.

Computer and/or Technical Skills:

  • Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc.
  • Operation and understanding of word processing, spreadsheets, and data management
  • Knowledge of GMP and safety requirements.
  • Knowledge of biotechnology operations such as, Aseptic Filtration Systems, Aseptic Sampling, Filter Integrity Testing, Fermentation Process, Inoculation Process, Chromatography Columns, Mixing systems, Weigh Scales, etc.

Work Environment & Physical Demands:

  • General work environment and physical demands as required to successfully perform the essential functions of this job.
  • Ability to work flexible hours as needed.
  • Ability to work under pressure and meet deadlines.
Not Specified
Quality Engineer
🏢 Trinity Consultants
Salary not disclosed
Albany, NY 6 days ago

On-Site Quality Engineer in Albany, NY


ADVENT Engineering, a Trinity Consultants Company, is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered in Dallas, TX with operations in the Eastern US and Canada, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.


ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.


The successful candidate will work with a group of Compliance Specialists involved in the creation, tracking, and closure of CAPAs associated with facilities maintenance. Forming and working within cross functional teams is considered an asset.

A combination of strong technical aptitude, preventative maintenance experience, and data analysis are the desired skill set.


This is an outstanding opportunity to join our growing team!


Qualifications:

Bachelor’s Degree/Undergraduate degree in Engineering, Biology, or equivalent. At least 5 years of related work experience in a QA or Compliance setting.


Requirements:

  • Acts as a liaison between the Facilities Department and onsite quality and regulatory groups to implement Corrective and Preventative Actions
  • Manages and participates in Facilities Department CAPA Program. Ensures that all activities related to CAPAs are performed in a timely manner and in compliance with procedures and regulatory requirements.
  • Daily monitoring and tracking of CAPAs assigned to the facilities department.
  • Responsible for all aspects of CAPA ownership including facilitation of cross functional meetings with relevant stakeholders, completion of extension requests where applicable, and submission of evidence to QA.
  • Initiation and ownership of requests and workflows in Computerized Maintenance Management System (BMRAM)
  • Attend Weekly Meetings to discuss CAPA progress and escalation of obstacles, including presenting, taking notes, managing agenda items and invites.
  • Ownership of CAPA Effectiveness Checks including the review and analyzing of relevant data and completing reports documenting findings
  • Provides support and training for Facilities personnel on regulatory and quality topics, such as proper documentation procedures and the use of QUMAS.



Key responsibilities:

  • Well-developed communication skills, both verbal and written.
  • Outstanding Organization skills (required to handle multiple projects concurrently)
  • Strong data analysis skills (excel, performance metrics).
  • Strong GMP background including working knowledge of preventative maintenance principles.
  • Familiar with a broad range of equipment used in pharmaceutical production, including but not limited to: bioreactors, chromatography skids, centrifuges/separators, air handlers, HEPA.
Not Specified
On Demand Clinical Educator
Salary not disclosed
Richmond, VA 5 days ago

Inizio Engage has a long-standing partnership with a leading Biotechnology company across Commercial, Patient Solutions and Medical Affairs businesses. 

 

To deliver educational support to identified patients enrolled in the program as outlined in the program guide.  To meet all relevant standards as set by the client and Inizio Client Account Manager/Regional Manager. 

 

This is your opportunity to join Inizio Engage and represent a top biotechnology company!  

 

What’s in it for you? 

  • Competitive compensation 

  • Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, paid maternity and paternity leave benefits, employee discounts/promotions  

  • Employee discounts & exclusive promotions 

  • Recognition programs, contests, and company-wide awards 

  • Exceptional, collaborative culture 

  • Best Places to Work in BioPharma (2022, 2023, & 2024) 

  • Certified Great Place to Work (2022, 2023, 2025) 

 

What will you be doing?  

 

  • Provide educational support to enrolled patients on the injection technique of approved Disease Modifying Therapies and provide education surrounding client-offered support services 

  • Provide approved disease state and prescribed therapy support to enrolled patients as agreed by the client and Inizio Client Account Manager/Regional Manager 

  • Consistently consider new and innovative approaches that can lead to the development of new partnership opportunities 

  • Complete all required administrative responsibilities in a timely manner.  These can include but are not limited to: 

  • Maintain professional registration and/or licensing as required by applicable state laws 

  • Attend local and national meetings and/or conferences, as required, to keep abreast of plans, activities, and developments and to exchange knowledge and best practices within the team 

  • Maintain all company equipment and materials in accordance with company instructions 

  • Comply with all Inizio policies and procedures, along with all client policy and procedures 

  • Be contactable during working hours to answer queries and perform duties 

  • Possess a full, valid United States driver’s license at all times and notify Inizio immediately of any offenses or accumulation of penalty points 

  • Perform other duties as requested 

 

What do you need for this position?  

 

  • Qualified Registered Nurse with current state license 

  • Associate/Bachelors/BSN

  • 2 years working with rare disease, preferred but not essential 

  • Clinical educator experience within the pharmaceutical or medical device industry required 

  • Excellent professional communication and presentation skills required 

  • Self-starter with high personal motivation 

  • Demonstrate organizational skills and/or have previous territory management experience 

  • Willingness to travel as needed within designated territory, attend regional/national meetings, and assist with coverage needs where able 

 

 

About Inizio Engage  

  
Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need.   

 

To learn more about Inizio Engage, visit us at:   

 

We believe in our values: We empower everyone/We rise to the challenge/We work as one/We ask what if/We do the right thing, and we will ask you how your personal values align to them.  

 

Inizio Engage is proud to be an equal opportunity employer. Individuals seeking employment at Inizio are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Inizio will consider for employment qualified applicants with arrest and conviction records.  

 

Inizio Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however, only qualified candidates will be considered. 

 

temporary
GI Faculty: Inpatient/Outpatient or Hospitalist | UT Tyler School of Medicine | Mentorship Available
✦ New
Salary not disclosed
Henderson, TX 1 day ago

Faculty position employed by the University of Texas at Tyler School of Medicine, practicing in UT Health East Texas facilities.

The University of Texas at Tyler School of Medicine is seeking a BE/BC Gastroenterologist for either a traditional inpatient/outpatient or hospitalist faculty  position. 

Note: Advanced training is not required for inpatient outpatient position; it is required for the hospitalist position.

Both seasoned and new graduates welcome to apply. New graduates will thrive in a  supportive environment with mentorship  opportunities from experienced providers. 

About the Position:

  • Team of Traditional Inpatient/Outpatient GIs and GI Hospitalist
  • ERCP access for advanced trained providers
  • Hospitalist: 7on/7 off schedule, 7 am-7 pm, Thursday-Thursday; 24-hour shift, response required (avg. 1-2 calls/wk. while on call)
  • Traditional GI position w/ Monday-Friday schedule- a mix of inpatient/outpatient
  • 4 GI Suites
  • Smart Technology: See more patients without extending your day. Our providers use  Epic EMR and  Ambience AI scribe technology to automate documentation, reduce administrative burden, improve patient flow, and ensure accurate coding—leading to better work-life balance and revenue.

A Recruitment & Benefits Package that Values Your Talent

At UT Tyler School of Medicine-UT Health East Texas Physicians,  we are committed to offering our providers exceptional compensation and benefits packages that foster  professional and personal growth.

We understand that in order for you to deliver the best care, you need to feel  appreciated and supported , which is why we prioritize the  health and well-being  of our providers and their families. To help accomplish this, we have designed generous compensation and benefits packages that may include:

  • Base Salary + wRVU production incentive
  • CME allowance
  • Commencement bonus
  • Consultative services by Navigate Student Loans
  • Relocation allowance
  • Residency stipend
  • Paid malpractice coverage
  • Health benefits + Retirement plan
  • Marketing + practice growth assistance
  • Potential Eligibility for Public Service Loan Forgiveness program

About UT Tyler School of Medicine:

The University of Texas at Tyler School of Medicine is the first medical school in East Texas and the seventh in The University of Texas System. Its mission is to train future healthcare professionals to embrace responsibility for the unique needs of rural and hard-to-reach communities and populations, particularly those in East Texas.

The school offers a robust Graduate Medical Education program, with 20 residency and fellowship training programs, enabling graduates to gain specialized skills in areas such as family medicine, internal medicine, neurology, psychiatry, surgery, and anesthesia. Additionally, UT Tyler’s Master of Biotechnology program provides students with an interdisciplinary curriculum that emphasizes medical research and biotechnology innovation, preparing them for careers in medical research, diagnostics and therapeutic development.

Construction is currently underway on a five-story, 248,000-square-foot Medical Education Building (MEB) in Tyler’s Midtown District. Connected by a skybridge to UT Health Tyler, the MEB will support interdisciplinary education for medical students and resident training. It will also aid as part of a medical education program expansion throughout the UT Health East Texas Health System. The building is scheduled for completion in the fall of 2025.

Emphasizing a community-centered approach, the UT Tyler School of Medicine combines advanced research, hands-on learning, and partnerships with regional healthcare providers to cultivate a new generation of physicians prepared to improve healthcare outcomes and enhance the quality of life in East Texas. Visit /medicine to learn more.

About Our Community:

Tyler, ranked #1 of USA Today's "Five Best Cities to Move to in Texas" in 2024- is known as the "Rose Capital of America." Centrally located in Northeast TX about halfway between Dallas and Shreveport, Tyler is among the fastest growing regions in Texas and is the largest retail, healthcare, and business center in upper east Texas. Residents enjoy affordable housing, high-performing public and private schools, and no state income tax! Home to The University of Texas at Tyler, the community has many family-fun attractions from botanical gardens to a zoo. The region is also recognized for outdoor recreational offerings, including hiking and biking trails, parks, and recreational lakes, including Lake Palestine and Lake Tyler.

Not Specified
Gastroenterologist | UT Tyler School of Medicine | Athens | Commencement Bonus
✦ New
🏢 UT Tyler School of Medicine
Salary not disclosed
Athens, TX 1 day ago

UT Tyler School of Medicine & UT Health East Texas is seeking a BE/BC  General Gastroenterologist  to join its practice at  UT   Athens, TX.

UT Health Athens hospital is located near  Lake Athens , which is a 1,799-acre reservoir on the east side of Athens. A beautiful community with an abundance of space for all outdoor recreational opportunities to take advantage of when you are not practicing medicine.

Our comprehensive facilities and hospital programs provide collaborative, multi-disciplinary care, and access to technologies including EPIC/EMR and DaVinci robot.  UT Health Athens is experiencing a period of unprecedented growth and development coupled with institutional expansion. Our new 60,000 sq. ft. medical office building is coming up in 2027.

Come embrace a practice setting and lifestyle of harmony in Athens, Texas, a rapidly growing regional hub in East Texas. Please click on the link below to learn more about Henderson County, TX.
Come experience Henderson County, Texas

About Your Work:

  • Join 2 advanced providers and support staff
  • Smart Technology: See more patients without extending your day. Our providers use  Epic EMR and  Ambience AI scribe technology to automate documentation, reduce administrative burden, improve patient flow, and ensure accurate coding-leading to better work-life balance and revenue
  • Full-time employed position
  • EUS or ERCP experience is desired
  • Both inpatient and outpatient services
  • M-F 8am-5pm (Clinic & Procedure days)
  • 18 – 22+ patients expected per day (clinic)
  • Opportunity to work with residents
  • Both seasoned and new graduates are welcomed to apply

A Recruitment & Benefits Package that Values Your Talent

At UT Tyler School of Medicine-UT Health East Texas Physicians,  we are committed to offering our providers exceptional compensation and benefits packages that foster  professional and personal growth.

We understand that in order for you to deliver the best care, you need to feel  appreciated and supported , which is why we prioritize the  health and well-being  of our providers and their families. To help accomplish this, we have designed generous compensation and benefits packages that may include:

  • Base salary + wRVU production incentive
  • CME allowance
  • Commencement bonus
  • Medical debt assistance + Consultative services by Navigate Student Loans
  • Relocation allowance
  • Residency stipend
  • Paid malpractice coverage
  • Health benefits + Retirement plan
  • Marketing + practice growth assistance
  • H1-B Support
  • O-1 Support
  • Potential Eligibility for Public Service Loan Forgiveness program.

About UT Tyler School of Medicine:

The UT Health East Texas system is comprised of nine hospitals, more than 90 physician clinics, over 500 employed providers, 13 regional rehabilitation facilities, two freestanding emergency centers, six urgent care clinics, regional home health services covering 41 counties, an EMS fleet of more than 60 ambulances and four helicopters, and a comprehensive seven-trauma center care network, including a Level 1 trauma center. Our primary service area has a population of over 600,000.

The University of Texas at Tyler School of Medicine is the first medical school in East Texas and the seventh in The University of Texas System. Its mission is to train future healthcare professionals to embrace responsibility for the unique needs of rural and hard-to-reach communities and populations, particularly those in East Texas.

The school offers a robust Graduate Medical Education program, with 20 residency and fellowship training programs, enabling graduates to gain specialized skills in areas such as family medicine, internal medicine, neurology, psychiatry, surgery, and anesthesia. Additionally, UT Tyler’s Master of Biotechnology program provides students with an interdisciplinary curriculum that emphasizes medical research and biotechnology innovation, preparing them for careers in medical research, diagnostics and therapeutic development. 

Construction is currently underway on a five-story, 248,000-square-foot Medical Education Building (MEB) in Tyler’s Midtown District. Connected by a skybridge to UT Health Tyler, the MEB will support interdisciplinary education for medical students and resident training. It will also aid as part of a medical education program expansion throughout the UT Health East Texas Health System. The building is scheduled for completion in the fall of 2025. 

Emphasizing a community-centered approach, the UT Tyler School of Medicine combines advanced research, hands-on learning, and partnerships with regional healthcare providers to cultivate a new generation of physicians prepared to improve healthcare outcomes and enhance the quality of life in East Texas. Visit  /medicine  to learn more.

Athens, Texas, established in 1850 and named after Athens, Greece, is the county seat of Henderson County and one of East Texas’s most culturally rich communities. Known for its blend of small-town charm and historical significance, Athens played an important role in regional agriculture, rail transport, and local industry.

The city is widely recognized as the “Birthplace of the Hamburger”, credited to local cook Fletcher Davis, and proudly calls itself the “Black-Eyed Pea Capital of the World” due to its historic farming legacy. Longstanding traditions like the Old Fiddlers Reunion, dating back to the 1930s, and the Black-Eyed Pea Jamboree celebrate the town's deep cultural roots.

Prominent landmarks include the Henderson County Courthouse (built in 1913), the Faulk and Gauntt Building (1896), and the East Texas Arboretum, which showcases local flora and trails. Athens is also home to the Texas Freshwater Fisheries Center, Lake Athens, and the Athens Scuba Park, making it a destination for nature lovers and outdoor enthusiasts.

Trinity Valley Community College, founded in 1946, serves as a hub for regional education. Today, Athens remains a vibrant community. Located just 75 miles southeast of Dallas, where history, heritage, and hospitality continue to define its identity.

Not Specified
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