Principal Scientist - Synthetic Molecule Process Chemistry

Genentech seeks a top-tier Principal Scientist in Chemistry with a proven record of sustained laboratory achievement and innovation to join the Synthetic Molecule Process Chemistry group. Leading from the bench as part of project-based research and development staff, the role focuses on developing enabling chemistry during early and late stage research for development-readiness decisions. This position drives innovation to advance science and ensure healthcare access.

The Scientist develops processes to manufacture Active Pharmaceutical Ingredient (API) from early development through Phase III route selection and delivers API supply for early phase clinical development. Working with the South San Francisco clinical manufacturing team, they participate in producing early phase GMP clinical supplies. Responsibilities extend to route selection for late stage GMP API manufacturing emphasizing safe, efficient, robust, environmentally sound chemistry.

A key requirement is interacting closely with discovery chemists and sourcing partners throughout development while establishing regulatory starting materials and a robust supply chain. The Scientist maintains a high level scientific profile internally and externally through scholarly achievements and pipeline contributions. Collaboration occurs in a CMC/cross functional environment.

The successful candidate develops processes for controlling bulk API quality per cGMP, ICH, and FDA regulations, plus attributes for formulation development. Tasks include writing relevant CMC sections of INDs and developing quality strategies. The mission advances through innovation, teamwork, creative problem solving, and state-of-the-art technology.