Senior Scientist, Analytical Development - Potency

Roche

South San Francisco (CA)

On-site

USD 105,000 - 194,000

Full time

8 days ago
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Job summary

Genentech’s Analytical Development & Quality Control (ADQC) team is expanding to advance stem cell therapies. We seek a scientist to lead MoA investigations for stem cell-derived and CAR T products, with deep hands-on cell culture, differentiation, and analytical assays including flow cytometry and molecular techniques.

You will design and execute bench experiments, develop SOPs, and communicate results to cross-functional teams while ensuring adherence to ICH guidelines within a CMC/regulatory

Qualifications

  • PhD or Master’s with hands-on bench experience in cell biology and related fields.
  • 80%+ time at the bench, performing experiments daily.
  • Expertise in cell biology and MoA-related assays.

Responsibilities

  • MoA characterization for stem cell-derived and CAR T products.
  • Cell culture, differentiation and functional assays.
  • Develop/optimize analytical assays (flow cytometry, qPCR/ddPCR, ELISA).
  • Document data, draft SOPs, present results to cross-functional teams.
  • Support assay development within a CMC/regulatory framework per ICH guidelines.

Skills

Cell culture
Flow cytometry
Molecular assays
qPCR/ddPCR
Statistical analysis

Education

PhD in Cell Biology / Biochemistry / Bioengineering
Master’s with 3+ years bench experience

Tools

GraphPad Prism
JMP

Job description

Genentech’s Analytical Development & Quality Control (ADQC) team is expanding. As a core division within Genentech’s Pharma Technical Cell & Gene Therapy organization, we ensure the safety, efficacy and quality of cell therapies. ADQC develops, validates and executes advanced physiochemical, immunochemical and biological testing methods for clinical and commercial release.

The Opportunity

We are seeking a highly motivated and innovative scientist to join our team. The ideal candidate will lead initiatives to define and interrogate the mechanism of action for stem cell-derived and CAR T cell therapy products. You will possess deep hands‑on expertise in cell culture and differentiation, functional assays, and analytical assays—including flow cytometry and molecular techniques—to drive the development of transformative cell therapies.

Key Responsibilities:

  • Mechanism of Action (MoA) Characterization: Lead initiatives to define and interrogate the mechanism of action for stem cell-derived and/or CAR T cell therapy products, including understanding signaling pathways that govern cell differentiation and downstream effector function.

  • Cell Culture & Functional Assays: Execute complex bench‑level experiments using cell lines and primary cells, including culture, passaging, and co‑culture techniques, as well as functional cell‑based assays.

  • Analytical Development: Develop and optimize physiological and analytical assays (e.g., flow cytometry, qPCR/ddPCR, ELISA) to characterize cell therapy products.

  • Data Documentation & Communication: Maintain accurate laboratory records, draft standard operating procedures (SOPs), and present functional data to cross‑functional teams.

  • Regulatory Compliance: Support assay development within a CMC/regulatory framework, ensuring alignment with phase‑appropriate validation and ICH guidelines.

Who You Are

Required:

  • You have a PhD in Cell Biology, Biochemistry, Bioengineering, or a related field; or a Master’s in Cell Biology, Biochemistry, Bioengineering, or a related field with 3+ years of relevant academic/industry experience.

  • You have demonstrated experience working at the bench. This is a bench scientist position, with the majority of the time (80%+) active at the bench, executing experiments daily.

  • You have a demonstrated level of expertise in cell biology.

  • You have the ability to culture, differentiate and characterize iPSCs, MSCs, or primary cells including their maintenance, passaging, cryopreservation, and thaw.

  • You have demonstrated proficiency in techniques used to characterize MoA including but not limited to flow cytometry, molecular assays, and immunoassays.

  • You have experience designing or executing bioassays that measure biological function rather than just markers, e.g. cell killing, serial re‑challenge assays, or proliferation.

  • You have deep familiarity with cell signaling pathways, cell differentiation, and downstream effector functions.

  • You are proficient in statistical analysis (e.g. GraphPad Prism, JMP) to support decision‑making

Preferred:

  • You have hands‑on experience in cell therapy products, including stem cell‑derived therapies and/or CAR T cells.

  • You have method development mindset and understanding of assay purpose and an awareness of ICH guidelines is a strong candidate differentiator

  • You have demonstrated strong interpersonal and communication skills with the ability to communicate technical knowledge in a clear and understandable manner, especially to non‑experts; you excel at problem‑solving skills and the ability to work under ambiguous situations.

  • You have excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities; you complete work in a timely, accurate and thorough manner.

Relocation benefits are not being offered for this role.

The expected salary range for this position based on the primary location of South San Francisco, CA is $104,700 - 194,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.
Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company’s policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

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