Principal Scientist/Associate Director, Drug Substance CMC
Responsibilities of the Principal Scientist/Associate Director, Drug Substance CMC:
- Manage drug substance CMOs to ensure uninterrupted drug supply manufactured within GMP compliance.
- Manage manufacturing operations, including tech transfer, scheduling, logistics, batch record review, change controls, review of validation protocols and reports, development of specifications.
- Serve as drug substance subject matter expert on teams.
- Author CMC sections for regulatory documents, including IND amendments and NDAs.
- Work collaboratively with quality, regulatory, discovery and commercial to meet project goals.
Requirements of the Principal Scientist/Associate Director, Drug Substance CMC:
- BS/MS in life science related discipline with 10+ years experience or PhD with 5 years experience.
- Must have experience with drug substance for biologics/large molecule in mammalian cell systems.
- Experience working in CMC/GMP setting.
- Displayed experience working/managing third party vendors (CRO/CMO).
- Experience with project through IND and Clinical Trials is helpful.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.