Upstream Bio Jobs in Usa

Community hospital part of system looking to bring on Director Bio-Medical! Sign On Bonus! Full Relocation!

Provides leadership and is responsible for the implementation of the program and services. Participates in defining strategic direction of the Bio-Med program through short and long-term goal setting, technology assessment and planning, medical device integration, operations, risk analysis, security, vendor and contract management, fiduciary responsibilities, and required reporting. Assists leadership with developing and strengthening facility and vendor relationships. Ensures that facility program meets and exceeds regulatory requirements for healthcare technology management. Develops and executes KPI’s.

Education:

• Minimum of Tech School certification or Associate's Degree. Bachelor’s degree in preferred.

Experience:

• 5+ years of previous related experience.

Technical Skills

• Experience with healthcare technology management programs including leadership Medical equipment knowledge (manufacturers, models, modalities, capital planning, etc…)
• Understanding of regulatory requirements for medical devices (CMS, TJC, CLIA, AABB, NRC,State, Local)

The Department of Biomedical Sciences invites applications for the Dr. Richard J. Bellucci Postdoctoral Fellowship. This Fellowship is one of the most prestigious offered by Creighton University and is reserved for highly promising early-career scientists who are engaged in hearing research. A successful candidate will be expected to conduct leading research in hearing science, mentor junior trainees, and develop a strong publication and presentation record.

We offer:

• Exceptional faculty and mentorship
• Numerous internal funding opportunities
• A strong University benefits package

Qualifications:

• Terminal degree (PhD and/or MD) with extensive, demonstrated experience in any of the following fields: Neuroscience, Chemistry, Developmental Biology, Bioinformatics or other related fields
• A commitment to hearing research
• Excellent communication skills, oral and written
• Strong publication and conference record
• Enthusiasm to work in a highly diverse, collaborative environment

Applicants must provide:

1. A ONE-page essay demonstrating their commitment to hearing research and a project that merits this Fellowship. This essay should include:
   1. A preliminary research plan, hypothesis, or major question.
   2. A member of Center faculty whose lab is appropriate for their research interest.
      1. Applicants are strongly encouraged to contact their proposed mentor in advance of applying to discuss their proposal. Current Center Faculty: Drs. Peter Steyger, David He, Marisa Zallocchi, Litao Tao, Justine Renauld, Jemma Webber, Allison Coffin, Kelsey Anbul, and Hui Hong

2. A biosketch (e.g., NIH Biosketch) that includes tangible products that support your appointment. These may include but are not limited to: Publications, Grant applications submitted and grants received, Patents, Podium and poster presentations, Professional development and career preparation, Volunteer experience

3. Names and contact emails of three professional referees who can provide a confidential letter of recommendation that speaks to their ability to conduct exceptional postdoctoral hearing research at a leading auditory-vestibular neuroscience institution. At least one referee should be outside the applicant's current institution.

Incomplete applications will not be considered.

The Dr. Richard J. Bellucci Translational Hearing Center is based on a highly collaborative and multi-disciplinary research model. We therefore welcome applicants who bring a broad range of applicable skills and perspectives to the Center as they fuel our innovation.

Under general supervision, provides a wide variety of moderately complex laboratory testing and technical lab support for a research facility. Requires knowledge of the processes/procedures in testing, documenting experiments, maintaining laboratory notebook, analyzing data, and reporting using complex statistical computer software.

Qualifications:

Bachelor's degree in related field of Science required;
2-4 year's research lab experience

Knowledge, Skills, Abilities:

Understanding of research methods, laboratory techniques, and care of laboratory equipment;

Ability to interpret data, troubleshoot and resolve technical issues;

Proficiency in Microsoft Office Suite to include Word, Excel; PowerPoint and Outlook;

Detail oriented;

Analytical skills;

Strong work ethic, excellent written and communication skills, and the ability to work independently;

Ability to work evenings, weekends, and holidays depending upon research needs

Physical Requirements:

Seeing: 75 - 100%

Hearing: 50 - 74%

Standing/Climbing/Mobility: 50 - 74%

Lifting/Pulling/Pushing: 25 - 49 % (pound: 15 lbs.)

Fingering/Grasping/Feeling: 75-100%

Travel: No

Exposure to Blood Borne pathogens: No and Yes

AAP/EEO Statement:

Creighton University is committed to providing a safe and non-discriminatory educational and employment environment. The University admits qualified students, hires qualified employees and accepts patients for treatment without regard to race, color, religion, sex, marital status, national origin, age, disability, citizenship, sexual orientation, gender identity, gender expression, veteran status, or other status protected by law. Its education and employment policies, scholarship and loan programs, and other programs and activities, are administered without unlawful discrimination.

Disclosure Statement:

This description describes the general nature of work to be performed and does not include an exhaustive list of all duties, skills, or abilities required. Regular, reliable attendance is an essential function and all employees are required to follow any other job-related instructions and to perform any other job-related duties as requested by their supervisor. Employees may also be required to work in excess of normal working hours as workloads and seasonal activities necessitate. A complete description is available in the Human Resource office located at 3006 Webster Street Omaha, NE. Creighton University reserves the right to modify duties, responsibilities and activities at any time with or without notice.

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.

Company Description

KOL Bio-Medical, founded in 1971, Virginia, specializes in bringing emerging medical technologies to the market. The company partners with medical device companies to promote new products and introduce advanced medical devices to hospitals and clinicians across the United States. KOL Bio-Medical focuses on establishing industry benchmarks in ethics, efficiency, customer service, and client trust.

Role Description

This is a full-time on-site role as an Territory Sales Manager located in New York, NY at KOL Bio-Medical. The Territory Sales Manager will be responsible for managing a growing territory, developing sales strategies, building client relationships, identifying new business opportunities, and achieving sales targets. Additionally, the Territory Sales Manager will collaborate with the marketing team to promote new products and technologies in the healthcare industry.

Qualifications

• Sales Leadership, Business Development, and Client Relationship Management skills
• Experience in developing and implementing sales strategies
• Strong communication, negotiation, and presentation skills
• Knowledge of the healthcare industry and medical technologies
• Ability to analyze sales data and trends to drive decision-making
• Bachelor's degree in Business Administration, Marketing, or related field
• Previous experience in medical device sales is a plus

Nosis Bio is a well-funded biotech startup exclusively focused on cell-specific delivery of RNA therapeutics. We are an all-scientist team of biologists, chemists, and machine learning experts that believe targeted extrahepatic delivery is the only thing preventing RNA therapies from becoming the standard-of-care for most chronic diseases. We combine deep expertise in receptor biology, generative AI, and high throughput in vivo data generation to exponentially accelerate the development of RNA therapeutics for new tissues. We are addressing a major unmet need across the industry and actively partner with pharmaceutical companies, research institutions, and biotech.

We are seeking a Technical Specialist / Research Associate to conduct in-vivo experiments to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) properties of therapeutic candidates. The successful candidate will have hands-on experience with in-vivo animal studies and will work closely with multidisciplinary teams to support various drug discovery projects.

• Perform in-vivo PK/PD studies in animal models, including intravenous (IV) and subcutaneous dose administration, blood sampling, tissue collection, and necropsy
• Ensure proper animal handling and dosing techniques, following established protocols and ethical guidelines.
• Assist in the execution of in-vivo studies to support the evaluation of drug properties
• Collect, organize, and document experimental data accurately and maintain laboratory records in compliance with company protocols and regulatory standards.
• Collaborate with cross-functional teams, including biology, chemistry, and translational science, to support project goals and timelines.
• Ensure compliance with all animal care and use guidelines, and follow company SOPs and safety protocols.

What we’re looking for:

• Ability to work on site in our lab spaces located in the California Bay Area – Research park at Marina Village (Alameda, CA) 
• Motivated and proactive with strong problem-solving skills.
• Team-oriented and open to collaboration across scientific disciplines.
• Title and track is dependent on academic and professional experience – we recruit diverse backgrounds including those with academic, non-profit, and industry experiences!

• General Requirement: AS or BS degree with 3+ yrs in vivo experience (industry or academia) and 1+ yrs industry (or similar) experience
• Ideal Qualifications: ALAT or equivalent certification

Amber Bio is a biotechnology company pioneering new gene editing modalities using multi-kilobase edits to reach previously undruggable patient populations. Founded by pioneers in the CRISPR field from leading institutions for gene editing research, the company is developing a first-of-its-kind RNA editing platform that can correct thousands of bases at once, thereby correcting genetic mutations safely and reversibly. If you are interested in building a new frontier in genetic medicine, we welcome you to apply.

Job Description: Research Associate III/ Senior Research Associate (Biodesigner), Assay Development / Bioanalytical Development

Position Overview: The Research Associate III/ Senior Research Associate in Assay Development and Bioanalytical Development will play a critical role in the development, qualification, and validation of bioanalytical methods to support our RNA editing programs. The successful candidate will work under the guidance of an assay development scientist to develop custom assays for the analysis of samples, including AAVs, cells, and tissues. This role also involves drafting key documents such as Standard Operating Procedures (SOPs) and method development reports.

Key Responsibilities:

• Method Development, Qualification, and Validation:
• Support the development, qualification, and validation of bioanalytical methods in accordance with regulatory guidelines.
• Develop, optimize, and execute robust bioanalytical methods for the characterization, release, and stability testing of Amber's gene therapy.
• Sample Analysis:
• Support drug absorption, distribution, metabolism, and excretion studies.
• Perform analysis of AAVs, cells, and tissues to support various stages of research and development.
• Lead efforts to streamline and optimize sample storage and processing, as well as establishing and maintaining critical reagent stocks and cell banks.
• Documentation Reporting:
• Draft and review key documents such as SOPs, method development, and sample analysis reports.
• Maintain accurate and detailed records of all experiments and analyses.
• Collaboration & Communication
• Collaborate with manufacturing and preclinical teams to support pipeline needs.
• Communicate and present findings clearly to internal stakeholders.

Qualifications:

• B.A./B.S. or M.S. in Molecular Biology, Biochemistry, Analytical Chemistry, or a related field.
• 3+ years of experience in bioanalytical and assay development in the biotechnology or pharmaceutical industry.
• Demonstrated strong proficiency in a wide range of molecular biology techniques such as molecular cloning, DNA/RNA extractions, RT-qPCR, ddPCR, and ELISA.
• Experience with cell-based assays and detection methods such as fluorescence, luminescence, and ECL.
• Hands-on experience using laboratory automated systems (e.g., liquid handlers, extraction robotics, etc.).
• Background in RNA-based therapies is highly desirable.
• Experience writing SOPs and reports supporting IND filings (e.g. development, qualification sample analysis reports, etc.)
• Knowledge of FDA and ICH guidelines for method development, qualification, and validation.
• Prior history in compiling and analyzing data and generating reports that are routinely presented to project teams.
• Ability to work effectively in a collaborative, fast-paced environment.

Preference will be given to those who display:

• High motivation, with a strong work ethic and dedication to generating impact.
• Attention to detail, with the ability to extract deep insights from data.
• Ability to go from ideation to data in an independent fashion.
• Long-term personal vision with defined career goals.
• Team-oriented thinking.
• Demonstrated excellence in small team environments, including a “no task is too small” attitude.

If you have a passion for advancing gene editing technologies and desire to be part of a pioneering biotech company, we encourage you to apply and join our ambitious team.

Please apply directly through LinkedIn.

Amber Bio is an equal-opportunity employer and encourages applications from candidates of diverse backgrounds. We value diversity and are committed to creating an inclusive and supportive work environment for all employees.

Amber Bio is a biotechnology company pioneering new gene editing modalities using multi-kilobase edits to reach previously undruggable patient populations. Founded by pioneers in the CRISPR field from leading institutions for gene editing research, the company is developing a first-of-its-kind RNA editing platform that can correct thousands of bases at once, thereby correcting genetic mutations safely and reversibly. Multiple openings are available on a rapidly growing team. If you are interested in building a new frontier in genetic medicine, please apply via LinkedIn.

Job Description: Associate Director or Director, Nonclinical Development

Position Overview:

We are seeking an experienced and highly motivated Director of Nonclinical Development to lead preclinical activities supporting our RNA editing pipeline. The successful candidate will design and oversee nonclinical pharmacology, biodistribution, and toxicology studies, ensuring timely and high-quality execution to support IND submissions. Reporting into the VP of Development, the candidate will provide both strategic leadership and hands-on management in a fast-paced startup environment, partnering closely with discovery, analytical, and manufacturing teams.

Key Responsibilities:

• Study Design & Oversight
• Design, oversee, and interpret preclinical studies (non-GLP and GLP), including pharmacology, biodistribution, and toxicology studies
• Select, negotiate, and manage CROs and external partners
• Write, review, and edit preclinical study reports and nonclinical sections of regulatory submissions
• Ensure data, methods, studies, and reports meet FDA, EMA, and ICH guidelines
• Strategic Leadership
• Define and implement the nonclinical development strategy for RNA editing programs from candidate selection through IND submission
• Identify key risks, mitigation strategies, and timelines for nonclinical workstreams
• Maintain up-to-date knowledge of regulatory guidance and emerging science in RNA editing, gene therapy, and AAV biology
• Collaboration & Communication
• Partner with discovery scientists to inform candidate selection strategy
• Work with manufacturing and analytical teams to ensure efficient hand-offs and successful integration of data across functions
• Communicate findings and recommendations clearly to project teams, leadership, and external stakeholders

Qualifications:

• PhD in Pharmacology, Toxicology, Biology, or related discipline
• At least 5 years in a biotech/pharma environment
• Experience in drug development for ocular and CNS indications
• Demonstrated track record of designing, monitoring, and interpreting preclinical safety & efficacy studies for IND submissions
• Strong understanding of FDA and ICH guidance on gene therapy
• Proven success in managing CROs and vendors for GLP/non-GLP studies
• Experience integrating nonclinical data into regulatory submissions
• Ability to synthesize complex data sets and communicate effectively across functions
• Ability to travel up to 25% of the time

Preference will be given to those who display:

• High motivation, with a strong work ethic and dedication to generating impact
• Attention to detail, with the ability to extract deep insights from data
• Ability to go from ideation to data in an independent fashion
• Long-term personal vision with defined career goals
• Team-oriented thinking
• Demonstrated excellence in small team environments, including a “no task is too small” attitude

If you have a passion for advancing gene editing technologies and desire to be part of a pioneering biotech company, we encourage you to apply and join our ambitious team.

Please apply directly through LinkedIn.

Amber Bio is an equal-opportunity employer and encourages applications from candidates of diverse backgrounds. We value diversity and are committed to creating an inclusive and supportive work environment for all employees.

Amber Bio is a biotechnology company pioneering new gene editing modalities using multi-kilobase edits to reach previously undruggable patient populations. Founded by pioneers in the CRISPR field from leading institutions for gene editing research, the company is developing a first-of-its-kind RNA editing platform that can correct thousands of bases at once, thereby correcting genetic mutations safely and reversibly. If you are interested in building a new frontier in genetic medicine, we welcome you to apply.

Job Description: High-Throughput Screening Research Associate II, III (Biodesigner II, III)

Responsibilities:

• Perform massively parallel reporter assays and high-throughput screens across diverse cellular contexts using cellular and molecular readouts.
• Develop and execute molecular biology workflows such as vector design and cloning, DNA/RNA extraction, RT-PCR, qPCR, and next-generation sequencing.
• Support cell culture activities and experiments in multiple cell lines, at small and large scales.
• Design and execute cell-based assays (AAV/lentiviral transduction, transfection, flow cytometry, immunostaining, and other plate reader assays).
• Engineer and characterize cell-based systems using synthetic biology tools and techniques.
• Conduct and troubleshoot experiments, independently and in collaboration with colleagues, to optimize screening throughput, sensitivity, and specificity.
• Proactively troubleshoot technical issues and recommend potential corrective actions based on personal observations and literature searches.
• Prepare summaries of data and present internally to colleagues and management.
• Draft SOPs, follow protocols, diligently document experimental data in lab notebooks, and organize and maintain electronic work records.
• Author scientific reports and data summaries.
• Collaborate with cross-functional teams to meet project goals, bridging early discovery with high-throughput screens to nominate and optimize candidates for further characterization.

Qualifications:

• Bachelor’s or Master’s degree in Biology, Biochemistry, Chemical Engineering, Biological Engineering, or a related field.
• At least 2 years of industry wet lab experience.
• Mammalian cell culture experience (culturing, transfecting and transducing cells, and DNA/RNA purification from cells).
• Molecular biology expertise (vector design and cloning, qPCR, primer and probe design, DNA/RNA extraction workflows)
• Critical thinker with excellent communication skills who thrives in a multidisciplinary, fast-paced team environment.
• Strong written and verbal communication skills.

Preference will be given to those who display:

• High throughput screening assay development in an industry setting.
• High motivation, with a strong work ethic and dedication to generating impact.
• Attention to detail, with the ability to extract deep insights from data.
• First-principles thinking, and an ability to refine one’s intuition based on additional data.
• Ability to go from ideation to data in an independent fashion.
• Long-term personal vision with defined career goals.
• High EQ with team-oriented thinking.
• Experience with pooled, high-throughput screens using next-generation sequencing-based readouts, and/or preparing screening plasmid libraries from synthesized oligo arrays.
• Experience with CRISPR-Cas systems and/or gene editing and delivery technologies.
• Experience preparing next-generation sequencing libraries (Illumina, PacBio, and/or Nanopore platforms).

If you have a passion for advancing gene editing technologies and desire to be part of a pioneering biotech company, we encourage you to apply and join our ambitious team.

Please apply directly through LinkedIn.

Amber Bio is an equal-opportunity employer and encourages applications from candidates of diverse backgrounds. We value diversity and are committed to creating an inclusive and supportive work environment for all employees.

Summary

Position open: 2nd shift (Monday-Friday). Local candidates preferred.

Responsible for performing fundamental lab support duties in assigned areas. Prepares lab for daily operations, including cleaning lab glassware, equipment, stocking materials, safety, cleanliness, waste disposal and related areas.

Essential Duties and Responsibilities

• Performing fundamental lab support duties in assigned areas.
• Prepares lab for daily operations, including stocking materials, equipment, safety, cleanliness, and related areas.
• Disposes of laboratory materials, waste and samples using well-established guidelines and instructions.
• Responsible for providing assistance, preserving, preparing, processing and maintenance of lab solutions, which involve knowledge on fundamental lab support policies, programs and practices while completing appropriate forms, documents and databases as needed.
• Clean workstation areas and equipment’s as per SOP.
• Maintain weekly inventory of lab supplies.
• Conduct periodic inventory reconciliation & administration as needed.
• Other duties as assigned (after training).
• Be able to stand for long periods of time.
• Establish and maintain effective relationships with team members.
• Ensure lab work and maintenance is conducted in accordance with SOPs; follow Transpire Bio safety rules and procedures.
• Comply with all Transpire Bio Corporate guidelines and policies.

Qualification Requirements

• Excellent verbal and written communication skills and interpersonal skills.
• High school diploma or equivalent with 1 year or more of experience in related work; OR an equivalent combination of education, training, and experience.
• Bachelor’s degree in chemistry, Biology, or related sciences with 0-1 years of experience.
• Able to work effectively in a friendly team environment.
• Highly organized and detail oriented.
• Strong time management and prioritization skills with ability to multi-task.
• Must be familiar with GMP.
• Mobility to work in a lab setting, use standard lab equipment and stamina to stand for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.
• Strong English language skills including writing ability and oral communication.

Title: Cell Therapy Manufacturing Supervisor

Location: Onsite - New Hampshire - my client supports with relocation!

Company: Cell and Gene Therapy CDMO

Metric Bio are partnering with a global CDMO on a search for Day Shift and Night Shift Manufacturing Supervisors to support a cell therapy manufacturing site.

This role is responsible for overseeing daily manufacturing operations, leading frontline teams, and ensuring the compliant, timely production of clinical and commercial cell therapy products.

What You’ll Do

• Coordinate and support cell and gene therapy manufacturing activities in compliance with established quality systems and regulatory requirements.
• Lead, coach, and develop manufacturing teams to meet operational objectives while supporting individual career development.
• Ensure the timely and complete delivery of clinical and commercial materials.
• Oversee and align cross-functional manufacturing strategies, including EHS, training, gowning, materials management, visual inspection, advanced planning and scheduling (APS), cleaning, environmental monitoring, and financial oversight.
• Maintain manufacturing areas to the highest standards of cleanliness, organization, and 6S practices.
• Support technology transfer activities and drive on-time achievement of defined milestones.
• Establish, implement, and continuously improve methods and procedures to achieve operational and performance goals.

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.

Job Description

The Manufacturing Associate is responsible for the execution of Upstream or Downstream production activities for early and late-phase Cell Culture programs within a GMP environment. Additionally, must ensure all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP).

Responsibilities:

• Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.
• Manufacture cell culture products per manufacturing batch records in compliance with quality standards, company policies and current regulations.
• Comfortable working on manufacturing floor
• Preparing buffers, media, and product

Required Skills & Experience

• Experience within pharmaceutical manufacturing / GMP/ cGMP environment
• Cleanroom experience
• Associates Degree or Bio Works Certification
• Ability to work 2-2-3 third shift schedule

Open date: November 7, 2025

Most recent review date: Saturday, Nov 22, 2025 at 11:59pm (Pacific Time)

Applications received after this date will be reviewed by the search committee if the position has not yet been filled.

Final date: Friday, Nov 6, 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.

The Department of Integrative Biology (IB) at UC Berkeley invites applications for a pool of non-tenure track Lecturer positions to teach Integrative Biology courses and General Biology (BIO 1B) courses as need arises. Our department's emphasis is on organismal biology.

Teaching Responsibilities

We are seeking outstanding lecturers who can teach/co-teach small, medium, and large size lecture and/or laboratory courses in the broad subject areas listed below:

* Ecology

* Evolution

* Organismal Biology

* Human Biology

* General Biology (BIO 1B)

* A detailed list of all courses are located online (please see below for links to our undergraduate and graduate courses).

General Duties

In addition to teaching responsibilities, general duties include holding office hours, creating and grading quizzes and/or exams, managing and assigning grades, advising students, preparing course materials (e.g., syllabus), and using a learning management system (e.g., bCourses at UC Berkeley, Blackboard, Canvas, etc.). For courses with discussion or lab sections, duties may include supervision, training and coordination of Graduate Student Instructors (GSIs).

For General Biology (BIO 1B) Lab Courses: The laboratory class currently covers three major sections: Evolution, Ecology, and Plant Biology/Organismal Diversity. Exercises include investigations into population genetics, phylogenetic relationships, macroevolution, bioindicators, and structure and function of organisms. BIO 1B is a gateway course to the major field of Integrative Biology that consists of three one-hour lectures and one four-hour combined discussion and lab each week. Lecturers will be required to lead one discussion and lab per week, create assignments, grade assignments, attend a Friday instructional meeting, be familiar with lecture, proctor exams, hold office hours and complete other instructional duties as assigned. Senior lecturers mentor new hires and GSIs.

Undergraduate Courses: undergrad/courses

Graduate Courses:

Enrolled in Ph.D., M.D., or equivalent international degree-granting program at the time of application.

Lecturer Courses: A Ph.D. or M.D. (or equivalent international degree) is required to teach a lecture course by the time of hire.

Familiarity with a web-based learning management system (e.g., Canvas) for grading and classroom management is preferred, as well as experience teaching a college-level course in the biological sciences (for example, previously employed as a graduate student instructor, teaching assistant, lecturer, or similar).

For General Biology (BIO 1B): Experience working with computer-based phylogenetic programs and teaching a class similar to UC Berkeley's BIO 1B lab courses is preferred.

A Ph.D., M.D., (or equivalent international degree) in the biological sciences is preferred.

• Curriculum Vitae - Your C.V. should include teaching experience with a listing of dates, courses, units, titles (Lecturer, Graduate Student Instructor/Teaching Assistant, Guest Lecturer, etc.). If you were not the full-time instructor, please indicate the percentage of contribution as a co-instructor or guest lecturer.

  
  

• Cover Letter - Review Integrative Biology (IB) courses we offer (academics/courses) and please include career highlights in the cover letter that specifically address your experience for the IB or Bio 1B courses you wish to teach. Courses other than those listed on the IB website are less likely to be taught, but may be considered.
  
  (Optional)

  
  

• Statement of Teaching - Three page maximum
  
  (Optional)

  
  

• 3 required (contact information only)

Help contact:

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.

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• "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
  

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• Bachelor's Degree in computer science or engineering
  
• 5+ years of work experience in in Workday, Integrations and API integration
  

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• Hands on work experience with Workday
  
• Experience with Workday Projects (preferably implementation experience)
  
• Able to write XSLT scripting both XSLT2.0/XSLT 3.0
  
• Hands on experience on Workday Studio
  
• Hands on experience in API integration either SOAP or Rest
  
• Hands on experience on PECI/WECI/PICOF and Core Connectors
  
• Understanding of Payroll data and Experience on US payroll and Global Payroll
  
• Ability to resolve issues/troubleshoot application in a high-pressure & time critical environment
  
• Experience using ITSM Service now tool
  
• Self-motivated to initiate actions and be responsible for consequent decisions.
  
• Good programming and debugging skills.
  
• Strong analytical, design thinking and problem solving skills.
  
• Strong written/verbal communications skills.
  
• Good team player and interpersonal skills.
  

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• Hands on experience on ADO ( Azure Devops) .
  
• Exposure to Agile practices ( Scrum /Kanban) .
  
• Understanding of ITIL Process guidelines, with specific focus on Service Operations and Incident Management.
  
• Functional Knowledge of HR in finance business.
  
• ServiceNow Development
  

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• Resolve incidents/failures and ensure closure within the SLAs
  
• Development of New Integrations within HR Workstream
  
• Collaborate with business partners on new and ongoing Workday Projects
  
• Efficiently Debug issues in case of Production Failure
  
• Participate in root cause analysis and provide solution/work around for HR cases
  
• Debug issues , incidents and provide solutions for the same through hands on development
  
• Proactively identify & implement opportunities to increase efficiency through automation & process efficiencies
  
• Participate in engineering efforts for ETL solutions i.e. system design , build, deployment, best practices and testing
  
• Create well documented change requests and follow up for approvals
  
• Communicate with global stakeholders, other IT teams, and business areas
  
• Provide Level 3 Support during the time of Production Failures
  
• Should be flexible for upskilling in different skill sets
  
• Work with upstream and downstream application teams for any risks or potential issues
  

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• You will join a team of seven scientists responsible for producing pilot-scale biological products that support biologics programs, trouble shooting and improving processes. The team implements new technologies to enhance operational capability, capacity, and efficiency across the site.
  

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• Technical & Operational
  
• Plan and execute downstream purification and scale-up activities including filtration, chromatography, and buffer preparation.
  
• Support upstream operations as needed to ensure seamless end-to-end process execution.
  
• Monitor, analyze, and interpret process and performance data; prepare clear summaries of findings as appropriate.
  
• Maintain laboratory readiness, including equipment maintenance, analytical instrument upkeep, consumable inventory management, and general lab support.
  
• Communication & Collaboration
  
• Present data, results, and conclusions in group meetings and cross functional discussions.
  
• Communicate technical information clearly and effectively to colleagues at varying levels.
  
• Work with a team-oriented, collaborative, and solutions-focused mindset.
  
• Maintain a strong safety focus in all laboratories and pilot operations.
  

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• Hands-on experience with downstream purification operations, including centrifugation, chromatography, TFF, and depth filtration.
  
• Proficiency with AKTA systems and UNICORN programming.
  
• Practical experience in chromatography column operations, including resin packing and unpacking at various scales (e.g. 4.4 to 30 cm internal diameter columns).
  
• Strong verbal communication, technical writing, and documentation skills.
  
• Ability to work effectively in cross functional teams and in a dynamic environment.
  
• Self-motivated, organized, and comfortable with scientific problem solving.---
  

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• Experience in pilot plant operations for biologics in a single-use facility.
  
• Familiarity with Process Development and/or current Good Manufacturing Practices (cGMP), technology transfer, plant operations, and bioprocess scaleup principles.
  

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• AA/AS degree with 2+ years of relevant industry experience (purification techniques), or
  
• BS/BE in Chemical/Biochemical Engineering, Biochemistry, Biology, or related discipline with 1+ year of relevant experience.
  

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• Initial Zoom screening, followed by 1:1 interview with the hiring manager and 1-2 team members.
  

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• Onsite
  

Previous Pharmaceutical/Biotech experience is mandatory for this role.

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation.

MMR Consulting has offices in Canada, USA, and Australia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems, and facilities. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.

This role is for Sr. BIOPROCESS ENGINEER will require to work on the design, project execution and commissioning of process systems in the biopharmaceutical industry. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers

The role can be hybrid where you can work partially remotely with periodic trips to client sites on projects all over USA.

Responsibilities

• Provide technical guidance into the design, project management, commissioning and start-up of equipment and facilities, for upgrades, renovations and expansions of client facilities and processes.

• Support project execution from Feasibility through to project completion/handover, including all project stages such as:

o Feasibility

o Concept Design, Basic Design, Detailed Design

o Procurement

o Construction

o Project Monitoring/Governance

o Commissioning & Qualification

• Prepare/perform/review process engineering drawings, calculations, whether as part of engineering design or as part of verification of calculations of vendors/client/other consultants, or Junior Engineers at MMR Consulting. Drawings may include PFDs, P&IDs as well as others. Calculations may include heat exchanger, pump, piping, control valve sizing, heat and mass balances, as well as other engineered calculations.

• Prepare/review technical specifications and data sheets for various equipment, instrumentation, and systems (such as vessel data sheets, etc).

• Review technical documentation such as SDS/HDS, layouts, manuals, datasheets.

• Manage other engineering design firms, equipment vendors, construction firms, and internal/external stakeholders as required to execute projects.

• Integrate safety into the design and execution of all projects (HAZOP reviews, PHSRs, design reviews with EHS representatives).

• Prepare/review User Requirements Specifications (URS)

• Provide input into Commissioning (FAT, SAT) and Qualification Protocols (IQOQ), as well as support execution of Commissioning & Qualification.

• Prepare/review automation sequences, as required for Process Automation, such as Functional Specifications, Valve & Alarm Matrices.

• Coordination with other engineering disciplines and other cross-functional departments (automation engineering, facilities engineering, process engineering, validation, project management, operations, quality, safety).

• Facilitate project management tools throughout the execution of projects, such as procurement tracking, vendor management, meeting minutes / action lists, risk register log, schedule updates, project updates.

• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.

• Travel may be occasionally required for meetings with the client and equipment fabrication vendors or Factory Acceptance Testing (FATs).

• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.

• Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.

• Visit construction and installation sites.

• Supervise contractors during critical installations of process equipment and associated utilities.

• Other duties as assigned by client, and/or MMR, based on workload and project requirements.

Qualifications

• Knowledge of GMP requirements for working in pharma/biotech facilities, with a Basic understanding of SOPs, Validation, Change Controls.

• 10+ years of experience pharma process engineering experience, with at least 6 years of bioprocess engineering experience (upstream or downstream)

• Excellent written and spoken English is required including the preparation of technical documents in English

• Experience in leading teams.

• Experience with, and knowledge of some of the typical Biotechnology processes & peripheral systems is required; Upstream Biotech Processes (Fermentation, Bioreactors, Centrifugation, Thawing), Downstream / Purification Biotech Processes (chromatography, TFF, DF, NF-MF), Fill & Finish equipment, Media Preparation, CIP/SIP systems, Buffer Preparation, clean utilities (PW, WFI, CS, PS)

• Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.

• Possess mentorship skills, to coach and develop junior and intermediate employees.

• Basic knowledge of AutoCAD is an asset.

• Engineering degree, preferably in Chemical, Biochemical, Mechanical Engineering or a related discipline.

Compensation: 140,000$ - 170,000$ based on experience.

Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

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