Associate Director, Cell Therapy Process Development

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Company: Senti Biosciences

Location: South San Francisco, CA 94080

Description:

The successful candidate will have prior experience with cell therapy early- and late-stage development. The individual will be responsible for planning and executing pivotal phase development activities of Senti's lead Allo-CAR NK program, including identification of critical process parameters, process characterization, scale up, and technical transfer to our CMO. The deliverables will involve selection and development of processes and technology for all unit ops including NK cell enrichment and activation, transduction, expansion, formulation, fill, cryopreservation and collaboration with the analytical development group to define suitable in-process samples for testing and process monitoring. This position will also support development and refinement of a robust donor screening program for NK cell sourcing.

Responsibilities
    • Independently design, plan, and execute process development studies to enable scale-up processes, characterization, process improvements, process comparability and process robustness
    • Support evaluation of alternate technologies for cell therapy processing for cell enrichment, transduction, expansion, and fill finish
    • Position will be onsite lab based with up to 70% time expected in the lab in collaboration with the process development team.
    • Pivotal phase process readiness of CT unit operations with a focus on Drug Product formulation/filling/cryopreservation that aligns with overall program strategy
    • Write and review technical documentation including process development reports, IND filings, change controls, batch records, tech transfer plans, process comparability protocols
    • Participate and influence a cross-functional development team to advance program development activities
    • Support pipeline project in collaboration with R&D team and develop early-stage and phase-appropriate processes for new programs.
    • Lead risk assessments, troubleshooting, and tech transfers as necessary


Qualifications
    • Advanced scientific degree (i.e. PhD) in in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology and 6 years of related experience OR
    • Master's Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering or Biotechnology and 8 years of related experience OR
    • BS/BA in Biology, Chemistry, or Engineering and 10 years of related experience


Salary and Benefits
    • Compensation for this role includes base salary, annual target bonus and equity
    • The base salary range for this role is $175,000- $208,000. Starting pay is determined by multiple job-related factors including a candidate's skills, education and experience level, benchmark, and internal parity
    • Significant growth opportunity as the company expands
    • Empathetic, supportive and collaborative colleagues and work environments

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