Associate Director of CMC
Associate Director of CMC
Walker Cole International
Greater Philadelphia
See who Walker Cole International has hired for this role
Walker Cole is partnered with a pioneering biopharmaceutical company with a global presence to identify a Associate Director of CMC. As the Associate Director of CMC, you will lead end to end CMC process development from Phase I - IV.
The Associate Director of CMC will be responsible for:
- Fully accountable for CMC strategy to successful BLA regulatory submission.
- Oversight of all external manufacturing activities with CMOs across the US, EU, and Asia.
- Build and implement a CMC strategy for Phase I - IV assets.
- As the Associate Director of CMC, you will lead technical transfer, process and method development.
- Design and implement drug product activities ready for registration, validation and commercial manufacturing.
The successful Associate Director of CMC will have:
- Masters or PhD in Biochemistry or Chemical Engineering
- 10 years of pharmaceutical industry experience
- Previous work experience in biopharmaceutical CMC product development
- Expert understanding of drug product manufacturing processes
biopharmaceutical | antibody | antibodies | protein | bispecific | bi-specific | CMC | process development | drug product | drug substance | pharmaceutical manufacturing | pharmaceutical CMC | biologics | Senior Manager | Associate Director
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Science, Research, and Manufacturing -
Industries
Research Services, Biotechnology Research, and Pharmaceutical Manufacturing
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