The Position
The Opportunity
We are seeking a highly motivated, self-driven, collaborative and experienced Senior Principal Scientist to join the Analytical Development team within the Pharma Technical Cell & Gene Therapy (PTC) organization based in South San Francisco. The successful candidate will be accountable for the development of cell-based potency and characterization assays to drive process/product understanding through application of a range of molecular and cellular approaches.
In this role, you will be expected to thoughtfully plan, create, and execute as an individual contributor while being able to influence in a highly matrix setting where you closely collaborate with cross functional teams (Process/Pharmaceutical Development, MSAT, manufacturing, QC, Quality, and gRED). As an analytical subject matter expert (SME), your work will propel the understanding of potential Critical Quality Attributes (CQA) and their correlation with cell fitness and clinical outcomes. This is an outstanding opportunity for a motivated technical scientist to make an indelible impact as Genentech strives to be an industry leader in cell therapy development and bringing innovative life-changing therapeutics to patients.
What You’ll Do
- Lead analytical method development and optimization for a regenerative medicine cell therapy program in the field of ophthalmology.
- Establish and justify specifications of drug product, cell banks, in-process controls based on historical datasets and analytical method performance.
- Contribute to authoring and review of CMC sections in regulatory filings.
- Spearhead analytical testing to enable process understanding, support pharmaceutical development studies (in-use, formulation), and comparability exercises.
- Review and draft method development reports, qualification/validation protocols and reports.
- Serve as SME for analytical tech transfer and method implementation.
- Build and continuously expand analytical capabilities to meet the growing needs of the cell therapy platform and evolving regulatory expectations.
- Contribute to analytical assessment of critical raw material on manufacturing process.
- Establish a suite of platform assays to assess cell health and genome integrity.
Who You Are:
- Ph.D. with 6+ years of relevant analytical development experience, particularly focused on development of cell and gene therapies.
- Working knowledge of control strategy development, including CQA identification.
- Fundamental understanding of ICH, FDA, and USP guidelines for analytical development and CGT products is essential.
- Possess a diverse analytical toolbox including multi-parameter flow cytometry, IncuCyte, Optical Genome Mapping, ELISA, Ella, FlowCam, impedance-based technologies and molecular techniques (ddPCR, qPCR, scRNAseq, NGS).
- Excellent verbal and written communication skills are essential.
- An accomplished experimentalist with a track record of solving technical challenges during method development.
- Experience with stem cell derived regenerative medicine is preferred.
- The ability to successfully work along and influence in a team/matrix environment.
- The ability to work in a fast-paced environment, manage priorities, communicate outcomes and maintain timelines for multiple projects.
Relocation funding is available for this role.
The expected salary range for this position based on the primary location of South San Francisco, CA is $140,500 - $260,900. 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, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.