Head of CMC (Biologics)
Greater New York Area
Competitive Compensation + excellent bonus/benefits
Duties and Responsibilities:
- Lead & provide strategic oversight for all the CMC efforts Analytical, Formulation, & Process Development efforts for internal and external networks
- Author, review and strategically impact CMC sections (Pre-IND, IND, BLA, & MAA submissions)
- Managing in-house CMC efforts and outsourced vendor related activities
- Interfacing with C-Suite & Investor relationships
- Focus on multiple compounds within their pipeline (from pre-clinical through commercialization))
Qualifications:
- M.S. or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 10-15 years of industry experience
- Experience working amongst CMC leaders such as Regulatory, Quality, and Commercial Manufacturing
- Experience overseeing outsourced vendors (CMOs/CDMOs)
- Past Management Experience is a MUST
