Head of Process Development CMC
1 month ago
Head of Process Development
Greater Boston Area | East Coast
Competitive Compensation + excellent bonus/benefits
Duties and Responsibilities:
- To be successful in this role, deep understanding of Process Development is required. You should be able to drive continuous improvement initiatives across biopharmaceutical process development stages.
- Provide internal oversight for all process development activities (cell culture, cell-line banking, protein purification); along with outsourced vendor
- Provide strategic oversight for several programs from discovery, early-stage development, commercialization, and Launch
- Strategic collaboration & support across R&D/CMC, Manufacturing, Quality Operations and Business Development/Commercial
Qualifications:
- Experience working cross functionally with senior leadership (QC, Analytical, Manufacturing, Regulatory, Business Development, etc. )
- Past Experience with CHO, HEK-293, or Yeast Fermentation based Process Development
- Experience overseeing outsourced vendors (CDMOs) and internal R&D activities
- Expert authoring and strategically working on IND - BLA/MAA submissions
- M.S or Ph.D. in Bioengineering/Chemical Engineering or a related scientific field w/ ideally 10 or more years of industry experience
Job Responsibilities:
•\tConducting Post Market Activities and Post Market Surveillance
•\tManaging Customer and Product Complaint Investigation programs
Education and Experience:
•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry
•\tBachelor's degree
•\tComputer proficiency
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