Principal Scientist, Late Stage Upstream Process Development (San Francisco, CA)
CEDENT
Client is seeking an experienced and driven scientist/engineer to lead late-stage upstream cell culture process development activities for clinical and commercial-stage large molecule programs. This individual will serve as the upstream lead for scale-up and tech transfer to manufacturing sites, establishing process validation (PV) strategy and PPQ/post-approval process support. Key Accountabilities/ Core Job Responsibilities
- Lead scale-up and tech transfer of the upstream process to manufacturing sites, ensuring alignment with control strategy and regulatory filings.
- Serve as the technical lead, responsible for upstream process activities for a late-stage large molecule programs including commercial manufacturing support
- Author and review relevant CMC documentation including PV protocols/reports and regulatory sections (e.g., BLA, IND amendments).
- Develop and execute strategies for process performance qualification (PPQ) and continued process verification (CPV).
- Collaborate cross-functionally with MSAT, Downstream, Analytical Development, CMC management, Manufacturing Operations, QA, QC, Regulatory, and Contract Manufacturers
- Represent upstream function in regulatory strategy, technical meetings, and CDMO interactions.
- Provide technical support for upstream process-related investigations, product impact assessments, change control assessments, CAPA assessments etc.
- PhD in biology, biochemistry, chemical engineering or related scientific discipline with minimum 7 years of cell culture process development experience in the biotech/biopharma industry; or BS/MS with 12+ years of experience.
- In-depth understanding of CHO-based fed-batch processes, scale-up/scale-down principles, and statistical tools.
- Thorough understanding of cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and scaleup/tech transfer activities
- Demonstrated experience with late-stage upstream process development, PPQ strategy, tech transfer and BLA authoring
- Strong knowledge of regulatory expectations for process validation and control strategies.
- Excellent communication, leadership, and cross-functional collaboration skills.
- Demonstrated ability for taking initiative, creativity, and innovation in problem solving
- Experience working with novel large molecule formats such as bispecific antibodies and Fusion proteins/enzymes is a plus
- Demonstrated technical writing, critical thinking, scientific problem-solving and communication skills
Vacancy posted more than 2 months ago
Similar jobs that could be interesting for youBased on the Principal Scientist, Late Stage Upstream Process Development (San Francisco, CA) in San Francisco, CA vacancy
- ...Organ Perfusion Research Associate / Scientist (San Francisco, CA) Responsibilities Develop and perform pig organ isolation and ex‑vivo evaluation... ...optimizing preservation protocol Ensure accurate sample processing and on‑time data reporting Qualifications Graduated or...SuggestedFlexible hours
CEDENT
San Francisco, CA4 days ago $155k - $180k
...Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen... ...Allogene Therapeutics is seeking Principal Scientist, Cell Starting Material - Process Sciences group within the Process...PrincipalFull timeLocal area$155k - $180k
..., with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen... ...seeking a highly motivated Principal Scientist to lead the Pilot Plant function within Process & Product Development (PPD)....PrincipalFull timeInternshipLocal area- ...an innovative and highly motivated Supervising Principal Scientist with expertise in cell therapy process development and people management. This individual will... ...demand. The company is headquartered in South San Francisco, California with its commercial-scale IDMO...PrincipalFlexible hours
Cellares
South San Francisco, CA16 days ago - ...Analytical Research & Development (Biologics ARD) is a global... ...a world-class team of scientists and leaders united by... ...Area site in South San Francisco has a long and rich... ...protein characterization, process understanding, and... ...South San Francisco, CA. The position requires...PrincipalFull timeLocal area
AbbVie
San Francisco, CA14 days ago - Principal Cloud Security Operations Engineer (Scripting, AWS, DevOps... ..., CCIE Security, CEH) in San Francisco, CA AWS, CEH, CISA, CISSP,... ...Engineer as a member of the Development Operations team will provide... ...solutions for cloud delivery processes. --Designs cloud security...PrincipalPermanent employmentFull timeWork experience placementRemote workRelocation
$145k - $200k
...Senior Recruiter – Generalist – San Francisco, CA Note: This position requires presence in the San Francisco office 4 days per week; the company... ...Chain & Manufacturing. You will own the entire recruiting process, from managing internal clients, qualifying job requirements,...Work at officeLocal areaWork from homeFlexible hoursLambda
San Francisco, CA4 days ago$18.67 per hour
...information obtained during the registration, update, and renewal processes or through NMLS notifications may impact your employment... ...an accommodation. Equal Opportunity Employer/Disability/Veterans Base Pay/Salary San Francisco,CA $18.67 - $18.67 / hourWork experience placementLocal areaImmediate startRelocationJPMorgan Chase Bank, N.A.
San Francisco, CA3 days ago$164k - $220k
...Software Engineer II - Android (Kotlin) San Francisco, CA or Remote (U.S.) We are looking for a talented... ...of professional experience with Android development using the Android SDK Experience with the entire app development process, from development to shipping on Google...Remote jobFull timeLocal area$45 - $50 per hour
...headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic... ...motivated Senior Associate Scientist to support the... ...scale manufacturing processes for Allogene’s CART... ...operation in upstream genetic modification...Hourly payContract workInternshipLocal area$175k - $200k
...Pharmaceuticals is a clinical stage biopharmaceutical... ...has offices in South San Francisco and San Diego,... ...robust, and scalable processes. Independently use PAT... ...scale reactions. Author development reports and technical... ...for a senior scientist; or 0‑2 years ’ experience...H1b$112k - $135k
...seeking highly motivated Sr. Scientist I of Analytical Development to help build our... ...preclinical phase through late-stage clinical development. Having... ...CTL analytical data (in-process, release, and stability... ...is located in South San Francisco, CA. At this time, we are not...Alumis
South San Francisco, CA29 days ago$56.67 - $69.56 per hour
...Administrator - Remote/Hybrid (Contract) - Motion Recruitment Partners - San Francisco, CA Contract: 6 months. Rate: $56.67/hr - $69.56/hr. Remote local... .... Accommodation will be provided in all parts of the hiring process as required under MRP's Employment Accommodation policy....Remote jobFull timeContract workTemporary workLocal areaFlexible hours$133.2k - $172.37k
...critical role in the discovery and development of life-changing scientific... ...opportunity supports the San Francisco area. Possess a... ...expenditures. Partner with Medical Scientists, National Account Managers,... ...in the job application process may contact ApplicantAccommodations...Full timeFor contractorsWork at officeLocal areaWorldwide$110k - $138k
...Principal Associate Scientist, Biology South San Francisco, California, United States Xaira is an innovative biotech... ...to transform drug discovery and development. The company is leading the development... ...profiling Prepare and process tissue samples, including...PrincipalFlexible hoursXaira Therapeutics
South San Francisco, CA3 days ago$210.4k - $331.1k
...TMed) drives early clinical development of novel therapeutics by partnering... ...with Discovery Sciences and Late-Stage Clinical Research to... ...candidates can engage in a hiring process that exhibits their true... ...stated on this posting. San Francisco Residents Only: -We will consider...PrincipalFull timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$200k - $275k
...Description: Senior Machine Learning Scientist sf, ca Senior Machine Learning Scientist,... ...on-site presence at our South San Francisco office a minimum of three days per... ...tools to support parts of the hiring process, such as reviewing applications, analyzing...Work at officeVisa sponsorshipFree visa3 days per weekESR Healthcare
San Francisco, CA5 days ago- ...Client:HeartFlow (Medical Diagnostic Company) Location:San Francisco, CA Hybrid (23 Days in Office) Duration:12+Months ContractRole... ...evaluation, monitoring, observability, and continuous improvement processes for Agentic AI systems. Collaborate with cross-functional...H1bWork at office
$80.8k - $143k
...Databricks’ Corporate Development & Ventures team partners with leadership to identify and execute acquisitions and strategic investments... ...strategic projects. Coordinate cross-functional due diligence process under guidance of the deal lead. Collaborate closely with...Work experience placementVC Stack
San Francisco, CA1 day ago$229k - $269k
...Revolution Medicines is a late-stage clinical oncology... ...currently in clinical development. As a new member of the... ...Senior Machine Learning Scientist to help accelerate... ...headquarters in Redwood City, CA is listed below. The... ...We will only collect, process and use any personal...Full timeLocal areaREVOLUTION Medicines
San Francisco, CA2 days ago$216k - $324k
...Counsel, Product, and will be based in San Francisco, CA. This attorney will serve as a key... ...privacy and AI governance into product development and operational decision-making. This... ...tools to support parts of the hiring process, such as reviewing applications, analyzing...- ...Advisory & Assurance Senior or Supervisor - San Francisco, CA San Francisco, California, United States The Role The Advisory & Assurance... ...relationships, and be responsible for staff professional development. The Senior or Supervisor must thrive in a fast-paced...Full timeTemporary workFlexible hoursWeekend work
Forth Recruiting
San Francisco, CA5 days ago $120k - $150k
...Revolution Medicines is a late‑stage clinical oncology... ...currently in clinical development. As a new member of the... ...Opportunity The Safety Scientist within Global Patient... ...headquarters in Redwood City, CA is $120,000 - $150,000... ...We will only collect, process and use any personal...Full timeREVOLUTION Medicines
San Francisco, CA2 days ago$229k - $269k
...Revolution Medicines is a late-stage clinical oncology... ...currently in clinical development. As a new member of the... ...Senior Machine Learning Scientist to help accelerate... ...headquarters in Redwood City, CA is listed below. The... ...We will only collect, process and use any personal...Full timeLocal area- ...an innovative and highly motivated Senior Scientist with expertise in cell therapy manufacturing to join the Process Development team. This individual will interface across... ...The company is headquartered in South San Francisco, California with its commercial-scale IDMO...Flexible hours
Cellares
South San Francisco, CA28 days ago - ...Description Our client, a CPA firm established in 1989, is based in San Francisco-but active globally-they provide comprehensive tax, financial... ...firm experience Full time, W2 Location: San Francicso, CA - (financial district) On-Site Responsibilities: Work...Full timeWork at officeWorldwide
RES Consultant Group
San Francisco, CA8 days ago $230k - $270k
...headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic... ...Senior Director, Head of Process Sciences group within... ...developing early and late-stage CAR-T processes... ...South San Francisco, CA and reports directly...InternshipLocal area$132k - $166k
Revolution Medicines is a late-stage clinical oncology... ...currently in clinical development. As a new member of the... ...Medicines is seeking a Scientist II to join the Drug... ...development. Manufacturing process development. Process... ...in Redwood City, CA is listed below. The range...Full timeLocal area$180k - $245k
...Principal Product Manager Location: Boston, MA OR San Francisco, CA (Hybrid – 2 days/week) About Liberate Liberate builds AI agents to automate manual tasks... ...vision, and enabling the company to scale from early-stage to high-growth enterprise adoption. You will...PrincipalFlexible hours2 days per weekVenturefizz Product Management Community
San Francisco, CA2 days ago$50 - $58 per hour
...Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen... ...motivated individual for the role of Scientist, Drug Product Process Science (Contractor) to join the Process...Hourly payContract workFor contractorsInternshipLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Principal Scientist, Late Stage Upstream Process Development (San Francisco, CA). Be the first to apply!
Related searches
- scientist 1 San Francisco, CA
- application scientist San Francisco, CA
- pharmaceutical scientist San Francisco, CA
- scientist biology San Francisco, CA
- research scientist machine learning deep learning San Francisco, CA
- scientist immunology San Francisco, CA
- senior analytical scientist San Francisco, CA
- materials scientist San Francisco, CA
- image scientist San Francisco, CA
- senior principal scientist San Francisco, CA