Principal Scientist - Cell Therapy Drug Product Process Development

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Genentech! The Opportunity The Cell and Individualized Therapies Department has an exciting opportunity for a Principal Scientist with a strong background in cell therapy drug product process development. The selected candidate will work as a part of the Cell Therapy Drug Product Process Development Team that is responsible for optimizing the formulation and drug product processing unit operations and clinical administration procedures for allogeneic CAR T cells, retinal pigment epithelial cells, and other cell therapy modalities. Responsibilities Independently design, execute, and interpret process development studies related to drug product unit operations for multiple cell therapy products with minimal supervision Identify potential process improvements and initiate projects after receiving buy‑in from relevant stakeholders on the scope, timing, and resource requirements Support development and implementation of new processing equipment, as needed Support the process transfer of drug product manufacturing unit operations to multiple manufacturing site(s) in close collaboration with MSAT colleagues Support the development of clinical thawing and administration procedures, and respond to related inquiries from clinical sites Serve as a functional representative on multiple cross‑functional teams and ensure strategy and timeline alignment for key work packages Author and review technical reports, process validation documents, and significant portions of regulatory submissions to support ongoing clinical trials and licensure Guide and influence the work of more junior team members Collaborate with research colleagues to assess the manufacturability of new modalities in the research portfolio Act as a resource within the department in multiple areas of expertise Required Qualifications BS/MS/PhD in Biochemistry, Biology, Chemical Engineering, Bioengineering, Pharmaceutical Technology or related discipline Approximately 7‑10+ years of cross‑functional pharmaceutical development experience in drug product process development and/or cell therapy process development with practical knowledge of fill/finish manufacturing processes (includes time spent in PhD program/post‑doc position) Experience developing processes for or characterizing therapeutic human cells in a pharmaceutical development setting (e.g. CAR‑T cells, regenerative cells, etc.) Knowledge of state‑of‑the‑art cell characterization assays (e.g. multi‑color flow cytometry) and aseptic technique Strong background in the relevant unit operations including formulation, sterile filtration, sterilization, aseptic processing, single‑use systems, filling, visual inspection, controlled‑rate freezing/thawing and cryopreservation, and clinical administration procedures Preferred Qualifications Prior experience with technology transfers, process validation and risk assessments Overall end‑to‑end understanding of the drug development process; ability to identify similar problems across different functions and implement cross‑functional strategies Additional Information The candidate must be highly self‑motivated, have excellent organization, oral and written communication skills, and be willing to work both independently and as a team member. The role is lab‑based and requires on‑site presence at the South San Francisco Genentech campus. Relocation benefits are available. Salary range for South San Francisco, CA: $120,800 – $224,300. Actual pay will be determined based on experience, qualifications, geographic location, and other factors permissible by law. A discretionary annual bonus may be available based on individual and company performance. Benefits information is available at Genentech’s benefits portal. Equal Opportunity Statement Genentech is an equal‑opportunity employer. We employ, promote, and otherwise treat 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. #J-18808-Ljbffr F. Hoffmann-La Roche AG