Jobs in North Richmond, CA
356 positions found — Page 17
Position title:
Instructor (Non-Senate, Non-Tenure Track)
Salary range:
A reasonable estimate for this position is $2,500 per course.
Percent time:
Part-time by agreement on a course-by-course basis.
Anticipated start:
Appointments are expected to begin in June 2026.
Review timeline:
Screening of applicants begins immediately and will continue as needed.
Position duration:
Program runs Monday, June 22, 2026 through Friday, July 3, 2026.
Application Window
Open date: March 10, 2026
Next review date: Tuesday, Mar 24, 2026 at 11:59pm (Pacific Time)
Apply by this date to ensure full consideration by the committee.
Final date: Thursday, Apr 9, 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
Berkeley Summer Sessions & Study Abroad is a vibrant and dynamic organization that collaborates across faculty, academic units, international partners and campus service providers to enable more than 15,000 current and prospective Berkeley students, visiting students, and high school students to participate in more than 600 summer courses, study abroad experiences, global internships, and other learning opportunities. We are committed to offering quality, innovative learning experiences through open enrollment to a diverse audience of world-wide learners, while supporting the campus missions and commitments to its stakeholders.
Berkeley Summer Sessions & Study Abroad is a part of the division under the leadership of the Dean of Extended Education that also includes University Extension and Osher Lifelong Learning Institute.
Summer Sessions, in partnership with UC Berkeley's Electrical Engineering and Computer Science department (EECS), invites applications for a pool of qualified, dynamic instructors with a commitment to Pre-College education in Computer Science, Programming, and Data Science to teach high school students (grades 10-12) in our Berkeley Summer Computer Science Academy. This intensive, non-credit program is offered in-person over 2 weeks during weekdays (June 22, 2026 - July 3, 2026) on the UC Berkeley campus with some online instructional components, such as an Instructor Orientation and a student pre-arrival Welcome Webinar.
Applicants must be authorized to work in the United States at the time of hire. Visa sponsorship is not available for this position.
Course Subjects
We are seeking qualified applicants who possess current subject matter expertise and teaching proficiency in the SNAP! programming language/coding software and in other introductory coding, computer science, data science, and artificial intelligence concepts.
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).
- For synchronous instruction (classroom), 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 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; reviewing and providing feedback on student work; utilizing University-approved course support platforms including the Canvas Learning Management System, Zoom, Google Workspace, etc.; reviewing and following University and departmental policies, logistics, and other guidelines; and responding to other requests from the Program Director or Department Director in a timely manner.
Berkeley Summer Computer Science Academy: summer-computer-science-academy
UC Berkeley's SNAP! Programming Language:
Qualifications
Basic qualifications (required at time of application)
- Bachelor's degree or equivalent international degree (or enrollment in a bachelor's degree or equivalent international degree program) required.
Additional qualifications (required at time of start)
- Bachelor's Degree or equivalent international degree required by the start date of the position.
- Minimum of one year of experience in related content area.
- Availability to teach in-person on the UC Berkeley campus weekdays between June 22, 2026 and July 3, 2026.
Preferred qualifications
- Advanced degree (or enrollment in an advanced degree) in course subjects.
- Subject matter expertise in SNAP! programming language/coding software and in other introductory coding, computer science, data science, and artificial intelligence concepts.
- 1 or more years of teaching experience in the course subject at a United States K-12, college, or university institution.
- Experience in creating syllabi, learning objectives, lectures/presentations, learning activities, assignments, assessments, exams, and quizzes.
- Ability to convey conceptual and complex ideas and information.
- 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.
- Ability to support the success of all students through inclusive curriculum, classroom environment, and pedagogy.
- Proficiency in (or willingness to learn) instructional and other technology, such as: Learning Management Systems (Canvas); lecture/presentation capture applications (Camtasia/Panopto); Microsoft Office (Word and PowerPoint); file sharing (Google drive or Dropbox); and Google Workspace tools (email, calendar, docs, sheets, slides, etc).
- Familiarity with Title IX, CANRA, CLERY, Family Educational Rights and Privacy Act (FERPA) and related federal and state laws, health & safety regulations, policies and procedures, and risk management guidelines and best practices related to working with minors or demonstrated ability to learn such laws.
Application Requirements
Document requirements
Curriculum Vitae/Resume - Your most recently updated C.V. or Resume.
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.
(Optional)
Apply link:
JPF05281
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
Berkeley, California (U.S.A.)
Title: Manufacturing Tech - Cell Therapy
Duration: 1 year contract
Location: Berkeley, CA
POSITION SUMMARY-
Responsible for clinical manufacturing of monoclonal antibodies (mAB) Drug substance within the Cell Culture Technology Center (CCTC). Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment.
• Responsible for all aspects of clinical manufacturing in the following areas: Cell Expansion, Cell Culture, Differentiation, Filling, Visual Inspection, Solution Preparation and Weigh/Dispense.
- Cell Culture Maintenance: Prepare and maintain cell culture environments, including media prep, cell counting, and growth monitoring.
- Quality Control: Perform quality checks, following strict protocols for contamination prevention.
- Data Recording: Accurately record data on cell growth and production metrics to ensure reliability.
- Collaboration: Work with Quality Assurance and Production teams to meet production targets
Skillsets:
- Manufacturing Experience: Hands-on experience working on a manufacturing floor ideally with exposure to downstream development processes.
- GMP and GDP: Experience with GMP processes, familiarity with SAP, and capability to handle 12-hour shifts
- Documentation: Experience with Batch Production Records (BPRs), SOPs, and log books, including:
- Experience with Batch Production Records (BPRs), SOPs, and log books.
- Ensure candidates know that if procedures aren’t followed, they are required to initiate and document deviations according to GDP standards.
- Experience preparing labels, filling out documentation, and reviewing logbooks accurately in a GDP-compliant manner.
Work Schedule
- Regular Hours: 9 a.m. to 5 p.m.
- Flexibility: Two weeks before each scheduled surgery, shift times may change to ensure timely delivery to the hospital. Flexibility to adjust hours within a 40-hour week is required.
Environment:
- Class B Workspace: All activities occur in a Class B space with a Biological Safety Cabinet (BSC).
- Environmental Monitoring: Includes testing and monitoring on equipment.
- Use of LM2 Freezers: Liquid nitrogen freezers are required for freezing products prior to shipping.
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
Title: Bioprocess Technician
Location: Berkeley, CA
Duration: 6 month contract, potential for FTE conversion
Required Skills & Experience
- 0-2 years of experience
- Aseptic qualifications or training (media fill, gowning certification)
- Buffer Prep
- Experience in drug product filling, visual inspection, or pharmaceutical compounding
- Strong understanding of GMP compliance
- Background in manufacturing processes such as silicon chip production or similar regulated environments
Job Description
We are seeking a highly motivated Bioprocess Technician. This role is critical in supporting aseptic operations and ensuring compliance with GMP standards for drug product filling and related processes. The ideal candidate will have hands-on experience in aseptic techniques, drug product filling, and GMP environments.
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
About the Company
Pegasus Solar is the fastest-growing provider of proprietary solar mounting hardware and project design software in the U.S. In 2025, we’ll manufacture and ship more than 13 million parts — with a Pegasus system installed once per minute. We’re a tight-knit, high-impact team driven to accelerate the widespread adoption of solar by making it simpler, faster, and better. Founded in 2012, Pegasus partners with installers to design and engineer products that improve installation efficiency and long-term reliability. With 130+ patents issued/pending and installations on over 350,000 buildings, Pegasus continues to set the standard for innovation and reliability in solar. Our mission is to give installers a better day on the job — and system owners a better product for life. If you’re passionate about clean energy, innovation, and hands-on manufacturing impact, this is where you’ll make a difference.
About the Role
We are seeking a Manufacturing Engineer to join our Manufacturing Operations team, based in Richmond, California. This role is ideal for a developing, hands-on manufacturing engineer who enjoys working directly in production environments and supplier facilities. Unlike a purely internal manufacturing role, this engineer will serve as the “eyes and ears” of the Manufacturing Operations team, spending significant time in the field supporting suppliers, qualifying tooling and production lines, auditing manufacturing processes, and ensuring quality and operational readiness across our supply base. The ideal candidate will bring experience in one or more core manufacturing processes such as metal stamping, machining, sheet metal fabrication, casting, extrusion, or cold heading, with strong preference for metal stamping in high-volume production environments. This role requires adaptability, strong documentation and communication skills, and the ability to operate effectively in smaller, fast-moving manufacturing environments with limited structure or support. This position is hybrid and best suited for candidates local to the Bay Area, with frequent travel (approximately 30–40%) to supplier and manufacturing sites.
Responsibilities
- Supplier Industrialization & Manufacturing Support
- Support qualification and ramp of supplier production lines, tooling, and manufacturing processes
- Conduct supplier audits, process validations, and manufacturing inspections
- Partner with suppliers to resolve technical and quality issues and improve production stability
- Support PPAP, line validation, and tooling readiness across the supply base
- Serve as a key field liaison between Pegasus engineering, manufacturing, and supplier partners
- Manufacturing Process & Production Support
- Apply hands-on manufacturing knowledge across processes such as stamping, machining, casting, extrusion, or cold heading
- Assist with process development, documentation, and continuous improvement initiatives
- Identify and troubleshoot production and quality issues at supplier and manufacturing sites
- Support creation of SOPs, work instructions, and manufacturing documentation
- Ensure adherence to quality standards and manufacturing best practices
- Cross-Functional & Quality Systems Engagement
- Work closely with Manufacturing Operations, Quality, and Engineering teams to ensure production readiness
- Support implementation and maintenance of quality systems and structured manufacturing processes
- Provide clear documentation, reporting, and communication from field activities
- Contribute to operational improvements across the manufacturing and supplier ecosystem
Qualifications
- Education: Bachelor’s degree in Mechanical, Manufacturing, or Industrial Engineering, or equivalent hands-on manufacturing experience
- Experience: 3–5 years of manufacturing engineering, production, or supplier industrialization experience
- Experience in at least one core manufacturing process (metal stamping strongly preferred; machining, sheet metal, casting, extrusion, or cold heading also valued)
- Experience working in smaller manufacturing environments (family-run, startup, or sub-50 employee facilities preferred)
- Experience supporting tooling, PPAP, supplier qualification, or production line validation
- Experience with quality systems required
Required Skills
- Hands-on understanding of manufacturing and production processes
- Ability to operate effectively in fast-moving, less structured manufacturing environments
- Strong documentation and communication skills (written and verbal)
- Experience creating SOPs, conducting inspections, and auditing manufacturing facilities
- Problem-solving mindset with strong technical curiosity
- Ability to work cross-functionally and independently in the field
- Comfortable spending significant time on manufacturing floors and supplier sites
- Travel readiness: Willingness to travel approximately 30–40%
Equal Opportunity Statement
Pegasus Solar is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Title: Drug Production Specialist
Location: Berkeley, CA
Duration: 1 year contract to hire
Required Skills & Experience
- 1-2 years of experience in pharmaceutical manufacturing
- Strong understanding of GMP compliance and experience working in a GMP facility
Job Description
We are seeking a highly motivated Drug Product Specialist to join our Cell Therapy Manufacturing team. This role is critical in supporting aseptic operations and ensuring compliance with GMP standards for drug product filling and related processes. The ideal candidate will have hands-on experience in aseptic techniques, drug product handling, and GMP environments.
Perform environmental monitoring in classified areas
Prepare solutions and manage inventory for manufacturing operations
Support aseptic processes including drug product filling and visual inspection
Maintain and complete electronic batch records accurately
Participate in gowning qualification, aseptic training, and media fill exercises
Assist in routine operations and troubleshooting within GMP guidelines
Collaborate with cross-functional teams to ensure smooth production flow
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
Are you an experienced Prin IT Business Analyst with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Prin IT Business Analyst to work at their company in Fridley, MN.
Position Summary: Looking for a business analyst to help with early engagement with the Neuromodulation business. Help to understand the business problem, look at solutions to solve the problem, and define the value to the business. Define business requirements for the solutions. Work with corporate IT to review existing solutions and vendors for fit to business requirements. Develop solution options and approaches for implementation.
Primary Responsibilities/Accountabilities:
- Responsibilities may include the following and other duties may be assigned. Engages with business leaders to understand how strategies and data-driven changes can improve efficiencies and add value. Work with data sets to define use cases to improve products, processes and/or services. Collaborates with Business Partner (BP), business stakeholders and IT Product Owners / Managers to develop business requirements for product or system changes. Determine and document business problems and identify solutions internally and externally to solve business problems. Develop plan and technical resources necessary to implement solution. Work with others to finalize timeline to implement. Functional Skills: Ability to analyze data and trends in order to develop software recommendations to solve business problems, develop a plan to implement solutions. Additional Skills: Problem Solving, Detail Oriented, Cross-Functional Collaboration, Customer Service, Process Improvement, Communication. Technology: Understanding of systems, software and technological concepts, Familiarity with data analysis tools.
- PECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
- DIFFERENTIATING FACTORS Autonomy: Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower level specialists.
- Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area. Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation.
- Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems. Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision-making. Leadership and Talent Management:
Qualifications:
- Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.
- Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management.
- Requires 7+ years of experience with a Bachelor's Degree or 5+ years of experience with an advanced degree or 12+ years of experience with a High School Diploma or equivalent.
- Business analysis or Solution Architecture experience
- Taking an undefined business problem through to a solution
- Researching technology options and fitting them to business needs.
Are you an experienced Contract Associate with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Contract Associate to work at their company in San Rafael, CA.
Primary Responsibilities/Accountabilities:
- End-to-end contract management, including receiving and submitting, monitoring and tracking a large volume of contracts from draft through final signatures
- Monitoring and tracking a large volume of requisition requests from submission to financial approval and PO creation
- Creating and submitting contract and financial requisition requests using SAP/Ariba (contracting & procurement platform) and Coupa/Spend Source (spend management tool)
- Researching vendors in systems to determine if vendors are active, prior to contracting new relationships; handle new supplier submissions or updating existing suppliers as necessary
- Drafting and routing multiple contract types for review/negotiation: Non-Disclosure Agreements, Scopes of Work, and Change Orders
- Acting as a liaison between the Client, internal business partners, and outside vendors to facilitate contract execution
- Building and maintaining relationships with internal business partners
- Engaging with other functional areas within Client to assess and respond to contracting and requisition needs, obligations, and revisions
- Monitoring and coordinating complex workflows between the business, Procurement, Finance and Legal Departments to ensure tasks move forward in a timely manner
Qualifications:
- Prior experience in contract management required
- Strong acumen for SAP/Ariba and Coupa/Spend Source platforms
- Comfortability with ambiguity and navigating complex processes and systems
- Ability to work autonomously and proactively, capable of troubleshooting and figuring things out
- Detail-oriented: strong proofreading and editing skills
- Strong computer skills in database management and document preparation (Word, PowerPoint, Excel)
- Ability to manage heavy workload and aggressive timelines in a timely manner, prioritize, and work under pressure
- Strong written and verbal communication skills
- Customer service oriented: must be able to communicate effectively with internal business partners as well as external vendors/suppliers
- Education: Prior experience
Preferred:
- Experience in contracts administration or other relevant experience is strongly preferred.
- Experience at a large law firm or within an in-house legal department of a public company a plus.
- Experience within biotech/pharma/medical device industry or other contract-intensive fields a plus.
- Familiarity with SpringCM is a plus.
- Science background is a plus
Senior Administrative Assistant
6-Month Contract
Hybrid (as needed) in San Rafael, CA (approximately 5 days/month onsite)
Must be able to work on a W2
Requirements
- Provide primary administrative support to the Head of Global Pharmacovigilance and the broader Global Patient Safety (GPS) team.
- Serve as a central point of contact, facilitating communication and supporting operational and project-based activities across departments.
- Proactively schedule and coordinate meetings and conference calls, including calendar management, room reservations, technical setup, catering coordination, preparation of materials, and recording of meeting minutes as needed.
- Anticipate and resolve scheduling conflicts to ensure productive and well-attended meetings.
- Oversee logistics for offsite meetings and team events, including hotel and restaurant bookings, catering arrangements, and team-building activities.
- Arrange business travel in accordance with company policy, managing flight, accommodation, and transportation bookings while adhering to budgetary and compliance requirements.
- Prepare and process expense reports accurately and promptly using systems such as Concur, ensuring complete documentation and timely reimbursement.
- Monitor and replenish departmental office supplies to support daily operations.
- Act as liaison for IT-related issues, facilitating timely resolution to support team productivity.
- Actively participate in on-site and off-site team meetings to support communication and operational continuity.
- Maintain and coordinate calendars for department leadership and team members.
- Submit and track departmental contract requests within the contract management system, ensuring accurate status monitoring.
- Monitor and reconcile departmental invoices to ensure financial accuracy and timely payment.
- Develop and maintain project trackers and spreadsheets, follow up on deliverables, and support status reporting.
- Organize and maintain departmental files within the document management system to ensure accessibility and preservation of institutional knowledge.
- Update and maintain departmental contact lists and organizational charts.
- Manage multiple priorities in a fast-paced, deadline-driven environment with strong attention to detail.
- Utilize Microsoft Office Suite, Concur, SharePoint, and other business tools to support efficient workflow.
- Communicate effectively with internal and external stakeholders, demonstrating professionalism, discretion, and sound judgment.
- Work independently, quickly learn new tasks, and proactively anticipate departmental needs.
Qualifications
- Minimum of 5 years of administrative experience within the biotechnology or pharmaceutical industries.
- Experience supporting pharmacovigilance functions highly desirable.
- Bachelor’s degree highly preferred.
Ray Therapeutics mission is to restore vision to people with retinal degenerations. RayTx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate RTx-015 in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications.
We are currently seeking a highly motivated and detail-oriented Manager, CMC Product Management to join our team in the mission to restore vision to patients. This role will report to the Director, CMC Product Management and will be responsible for managing day-to-day CMC product activities across early and late phase development.
The Manager will work closely with internal CMC teams, Quality, Regulatory and external CDMOs to ensure timely execution of manufacturing plans, regulatory deliverables and product lifecycle activities. The position requires hands on process and/or analytical development and GMP AAV manufacturing and/or testing experience with the ability to be a team player both internally as well as with our external partners. The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement and will require travel to our contract development and manufacturing organizations in the United States.
Essential Duties and Responsibilities:
- Support execution of RayTx’s CMC product lifecycle activities across development stages, including process development, tech transfer, manufacturing and regulatory submissions.
- Manage assigned CMC product activities to ensure alignment with program timelines, milestones, and development goals.
- Track CMC deliverables, timelines and communicates progress to stakeholders.
- Collaborate with CMC Analytical and MSAT teams on tracking and trending initiatives and data management.
- Serve as a day-to-day point of contact for assigned CDMO and product distribution vendors.
- Review and provide input on GMP documentation including, but not limited to master production records, test procedures, deviations, CAPAs and completes records.
- Provide input into risk mitigation and communicate to internal team.
- Support preparation and review of CMC sections for regulatory filings (IND, CTA, BLA, MAA) and ensures adherence to GMP and ICH guidelines.
Qualifications and Experience:
- Minimum bachelor's degree in relevant scientific or engineering discipline.
- 8+ years relevant biotech experience.
- Hands on experience in GMP AAV gene therapy manufacturing preferred.
- Knowledge of AAV analytical methods and testing preferred.
- Tech transfer experience preferred.
- Experience working with CDMO and external vendors preferred.
- Excellent scientific knowledge and acumen.
- Familiarity with CMC regulatory requirements and documentation
- Ability to travel up to 20%
Compensation Range and Benefits:
- For this role, the anticipated base salary range: $135,000 to $160,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
- Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.
At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.
All employment is decided on the basis of qualifications, merit, and business need.
Search Firm Representatives Please Read Carefully
Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.
Ray Therapeutics mission is to restore vision to people with retinal degenerations. RayTx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate RTx-015 in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications.
We are currently seeking an exceptional team member to join our team as a CMC Technical Development Specialist. This role will report to the Senior Director, CMC Analytics, and will have an active role supporting the general CMC department as well as our process, product management, and MSAT teams. The position requires hands on support for AAV analytical development, transfer, and qualification through validation support for our lead candidates from Pre-IND to BLA. The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement and may require travel to our external vendors at in the United States. If the lab is where your curiosity comes alive and breakthroughs spark your excitement, this position may be right for you.
The job duties and responsibilities include but is not limited to the following:
- Collaborate with analytical development and process development teams to develop, qualify and/or validate AAV gene therapy assays.
- Develop analytical methods and support method optimization/characterization.
- Independently execute analytical assays including molecular biology assays, chemical/biochemical assays, and cell-based biological potency assays, for internal CMC commitments, process monitoring, release and stability.
- Develop protocols for analytical transfer, qualification and /or validation studies and execute associated wetlab work.
- Present aasay methodology and principles to external partners and support method transfers.
- Execute routine assays with high presicion and provide data summaries and reports in a timely manner.
- Document all raw data, method plans, and summarize conclusions.
- Author and review Test Methods, Reports, and Protocols.
- Work in the lab independently and in a collaborative environment with minimal guidance.
- Support CMC outside of analytical teams to move programs forward, e.g. shelf-life determination, upstream characterization etc.
Qualifications and Experience:
- BA/BS in Biochemistry, Biology, bioengineering or a related fields and at least 10 years of Biotech/pharmaceutical industry experienced required.
- Experienced in compendial methods, CE-SDS, gel electrophoresis, HPLC, DLS, ddPCR or qPCR, ELISA, and cell based potency assays.
- Hands on experience in AAV gene therapy analytical methods and testing required.
- Experience in precision pipetting and cell culture (handling, aseptic techniques, maintenance), plate-based imaging, ELISAs, luminescence and fluorescence detection techniques.
- Curiosity and good scientific knowledge and acumen.
Compensation Range and Benefits:
- For this role, the anticipated base salary range: $145,000 to $160,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
- Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.
At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.
All employment is decided on the basis of qualifications, merit, and business need.
Search Firm Representatives Please Read Carefully
Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.