Senior Director of Manufacturing Science and Technology

4 weeks ago


San Diego, California, United States Tanvex BioPharma Inc Full time
Job Summary

The Senior Director of Manufacturing Science and Technology will lead and enable MSAT as a strategic champion, manager, and Subject Matter Expert (SME) for mammalian and microbial drug substance manufacturing of biologics for clinical and commercial use in our contract development and manufacturing (CDMO) and in-house programs. This role is responsible for the MSAT team and all functions in support of cGMP drug substance manufacturing, including technology transfer, monitoring, troubleshooting, process validation, improving drug substance production processes and technologies, and client interactions.

Key Responsibilities

- Apply highly advanced engineering principles to the transfer, monitoring, validation, and troubleshooting activities of drug substance manufacturing processes.
- Partner with cross-functional teams at decision level, including Process Development, Quality, Supply Chain Management, External Manufacturing (Drug Product), Engineering, and all clients.
- Drive implementation of new technologies to improve manufacturing efficiency and ease of operations.
- Plan and implement long-range technology programs. Propose, design, and implement advanced major scientific experiments that contribute to the overall program objectives and extend the boundary of knowledge in their field.
- Oversight of all MSAT client interactions and management of the MSAT team through individual goal setting, performance reviews, motivation, coaching, and feedback for individual career growth and development.

Requirements

- Bachelor's or advanced degree in chemical/biochemical engineering, chemistry/biochemistry, biological sciences, or related disciplines.
- 15 years of relevant experience, or MS with 10 years of relevant experience, or PhD with 5 years of relevant experience in biopharmaceutical research and manufacturing settings.
- 5 years of management experience required.

Working Environment

This role requires up to 80% of time spent working in a standard office environment. The noise level in the work environment is usually quiet to moderate. The employee will be required to work within a biosafety level 1 laboratory environment, operate standard lab equipment, and wear safety glasses, lab coats, and disposable gloves as part of their daily job duties. Additional personal protective equipment may be required for additional hazards. The employee may work on weekends or nights, or on-call as needed.

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