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Vice President Head of CMC and Process Development
2 months ago
Location: Cambridge, MA (Onsite)
Science: Biologics/ Protein Therapeutics
Job Overview: Lead and oversee the development, optimization and tech transfer of bispecific protein therapeutics. Lead clinical manufacturing efforts between internal teams and external CDMO’s for clinical development preparing for IND.
Primary Job Responsibilities:
- Lead internal process development, optimization and tech transfer of upstream and downstream process development for clinical development pipeline
- Select, manage and oversee CDMO partnerships
- Tech transfer of methods and processes to CDMO for early stage clinical manufacturing
- Prepare and oversee IND enabling including regulatory CMC sections
Primary Job Requirements:
- Seasoned leader with extensive industry experince in biologic CMC and process development at the VP level
- Extensive experience selecting and overseeing CDMO’s for tech transfer of protein manufacturing including both upstream and downstream methods
- Exposure to managing analytical studies for IND
- Travel to CDMOs
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