Head of CMC (Biologics)

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