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Director CMC
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- Company is seeking an experienced Director of CMC, to be based in their Jersey City, NJ offices 1 - 2 days a week (flexible schedule for the ideal candidate).
- Reporting into the Head of CMC, the selected individual will be responsible for oversight of CMC operational, technical activities and strategies for drug substance and drug product development including analytical development/validation with support and oversight from the Head of CMC. The Director will collaborate with supply chain for management of clinical trial supplies (labeling/packaging, manufacturing
- Collaborate with cross-functional team leaders, including development, CMC regulatory, supply chain and quality assurance to ensure seamless execution of CMC strategies and activities.
- Direct scale-up of fermentation, downstream purification, and synthetic manufacturing processes for drug substance candidates.
- Responsible for technology transfer of drug substance manufacturing process including fermentation and downstream purification to CDMO and external partners.
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