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Specialist / Sr. Specialist, CMC
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- Job Overview: This role involves leading key CMC activities, collaborating across departments, and managing critical analytical and manufacturing processes in a cGMP environment as part of the Technical Operations team.
- Lead the development, transfer, and validation of analytical methods for preclinical and early-phase clinical projects across internal and external sites.
- Direct CMC team efforts by organizing meetings, establishing agendas, recording decisions, assigning tasks, and tracking progress to ensure timely achievement of project objectives.
- Collaborate with Quality and external partners to manage stability studies and review data for regulatory reports, while overseeing CMC quality documentation and vendor relationships to support analytical and manufacturing excellence.
- BS, MS, or PhD in chemistry, biochemistry, or chemical engineering with at least 3 years in CMC analytical development in biotech/pharma.
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