Senior Principal Scientist -Bioanalytical Assay- Cell Therapy

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The Senior Principal Scientist  serves as the scientific leader for Bioanalytical Strategy in support of our Cell Therapy portfolio. In this role, the individual will define and drive the bioanalytical strategy needed to answer the critical scientific questions that enable the successful development of cell therapy products. The Senior Principal Scientist will establish integrated, fit-for-purpose strategies that generate the evidence needed to inform development, regulatory, and portfolio decisions across multiple programs.

As the cell therapy bioanalytical subject matter expert, this role  will partner across Bioanalytical Sciences, Research, Translational Medicine, Clinical Development, CMC, Regulatory, and Computational Sciences to identify and prioritize the key scientific questions required to advance cell therapy programs. These include characterizing the in vivo fate of therapeutic cells, including cellular expansion, persistence, trafficking, biodistribution, phenotypic persistence and evolution, and immunogenicity, and evaluating how these attributes relate to efficacy, durability, and safety.

Working collaboratively across the organization, the leader  will establish harmonized bioanalytical strategies that enable consistent evaluation across programs, accelerate scientific learning, leverage shared assays and data, and maximize portfolio-wide impact. This individual will shape scientific direction across multiple programs, establish best practices across the Cell Therapy portfolio, and represent Bioanalytical Sciences as a scientific leader within cross-functional teams.

Opportunity:

As an integral member of our dynamic team, you will:

• Define and drive the bioanalytical strategy supporting the Cell Therapy portfolio, establishing integrated, fit-for-purpose data strategies that generate the evidence needed to answer key scientific questions and inform development and portfolio decisions.

• Identify, prioritize, and continually evolve the key scientific questions required to characterize the in vivo fate of therapeutic cells, including cellular expansion, persistence, trafficking, biodistribution, phenotypic evolution and persistence, and immunogenicity, and evaluate how these attributes relate to efficacy, durability, and safety.

• Partnering with the Bioanalytical Sciences project leads to developing integrated bioanalytical strategies that generate the evidence needed to address critical scientific questions while ensuring analytical approaches remain fit-for-purpose throughout development.

• Build strategic partnerships across Research, Translational Medicine, Development Sciences, Clinical, CMC, Regulatory, Computational Sciences, and platform organizations to align scientific priorities and integrate bioanalytical strategies across the portfolio.

• Harmonize scientific approaches, leverage shared assays and bioanalytical data, and establish portfolio-wide best practices for evaluating cell therapy products across programs and development stages.

• Drive consistency and scientific excellence in bioanalytical strategy by identifying opportunities to standardize approaches, enable cross-program data interpretation, maximize portfolio learning, and accelerate the development of current and future cell therapy modalities.

• Integrate bioanalytical, translational, clinical, computational, and manufacturing insights to support molecule progression, development strategy, regulatory planning, and portfolio decision-making.

• Translate emerging questions in cell therapy development into clear bioanalytical evidence-generation strategies, including recommendations for analytical approaches, data integration, and interpretation across programs.

• Evaluate emerging scientific and technological advances and guide the incorporation of innovative bioanalytical approaches that address evolving questions across the Cell Therapy portfolio.

• Represent Bioanalytical Sciences on cross-functional governance teams, scientific review committees, portfolio forums, and external scientific collaborations.

• Serve as a recognized scientific resource for cell therapy bioanalytical strategy across Development Sciences, providing expert guidance to project teams and senior scientific leaders.  Mentor scientists across matrixed organizations, foster scientific excellence, and contribute to the continued evolution of bioanalytical capabilities within Development Sciences.

Who You Are:

• Ph.D. in Immunology, Cell Biology, Biochemistry, Pharmacology, Bioanalytical Sciences, or a related life sciences discipline with a minimum of 7 years’ experience in the field of drug discovery or development with extensive biopharmaceutical industry experience leading bioanalytical strategy across discovery, translational research, and clinical development.

• Direct experience supporting the development of cell therapy products, such as CAR-T, TCR-T, TILs, iPSC-derived products, gene-edited cellular therapies, or other advanced cellular modalities.

• Deep understanding of the scientific and bioanalytical challenges associated with cell therapy development, including characterization of cellular expansion, persistence, trafficking, biodistribution, phenotypic evolution, and immunogenicity.  Expertise in developing integrated bioanalytical strategies and translating bioanalytical data into scientific insights that inform development and portfolio decisions.

• Strong knowledge of bioanalytical methodologies, including flow cytometry, molecular assays (qPCR/ddPCR), ligand-binding assays, functional bioassays, biomarker assays, and emerging multiomic approaches.

• Ability to influence scientific strategy, lead complex cross-functional initiatives, and drive decisions across multiple development programs without direct line authority.  Ability to build strategic partnerships across scientific and functional organizations and align diverse stakeholders around shared objectives.

• Recognized scientific leadership through publications, presentations, patents, regulatory contributions, and/or other significant scientific achievements.  Excellent written and verbal communication skills with the ability to communicate complex scientific concepts and strategic recommendations to multidisciplinary teams, senior leadership, and external stakeholders.

Preferred Qualifications

• Experience integrating bioanalytical, translational, clinical, computational, and manufacturing data to inform development and portfolio decisions.

• Experience developing harmonized assay and data strategies across multiple programs or related therapeutic platforms.

• Experience applying advanced computational or AI-enabled approaches to bioanalytical data integration and interpretation.

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of California is $173,100- S321,500.00 .  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.

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