Director/Senior Director Drug Substance Manufacturing needed for Rapidly growing Biopharma company
- Located in San Francisco
- Competitive and Comprehensive Compensation Package
- Multiple Openings
This Director will have the following Responsibilities:
- Responsible for all activities related to 1000L and 2000L scale manufacturing of late-stage clinical biologics.
- Primary responsibility for managing the CMO activities including process development, process improvements, technology transfers, scale up and clinical manufacturing of drug substance compounds.
- Plan the process characterization and other BLA enabling studies including small scale and at scale studies. Coordinate the execution of small-scale studies with the in-house Process Development team and the at scale studies with the CMOs.
- Lead cross functional meetings with Quality, Regulatory, Supply Chain, Process Development, Analytical and Drug Product to build consensus on key issues and facilitate decision making to move the project forward.
The Ideal Candidate will have the following skill set:
- PhD/MS/BS in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology or a relevant field.
- 10 years' experience with PhD, 12 with MS or 15 with BS in pharmaceutical environment with a proven track record of leadership and success.
- Strong track record having managed cross functional teams and projects as well as direct experience managing multiple CMO sites.
- Extensive experience in manufacturing of Biologics, ideally Monoclonal Antibodies (MaBs), recombinant mammalian or microbial compounds.
- Prior work with late stage and commercial biologics with experience in process characterization, PPQ, process validation and other BLA enabling studies and CPV programs.