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Associate Director in Biotech
- Provide technical leadership across multiple manufacturing technologies including patenteral biologics, API, and oral solid dosage form.
- The MS team provides technical support for manufacturing investigations, process validation, regulatory submissions, and process transfer.
- Ensure CMO manufacturing performance is monitored and collaborate with CMOs to ensure appropriate measures are in place to maintain control over cGMP operations.
- Provide hands on support for MS activities as needed.
- Represent Global Operations on CMC teams.
- A minimum of 10 years of related work experience.
- Prior managerial experience. Ability to mentor staff in technical areas outside your core expertise.
- Subject matter expert in at least one manufacturing discipline (parenteral filling, API synthesis,oral solid dosage form manufacturing). Capable of technical interactions with internal and external process scientists.
- Experience using statistical process control and process analytics for evaluating and controling cGMP manufacturing operations.
- Demonstrated experience working cross functionally, in a technical area outside of core expertise.
Education M.S. or Ph.D. in a technical discipline related to Pharmaceutical Manufacturing (Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Engineering, etc.)
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