Associate Director of CMC

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