Sr. Director/ Exec. Director- CMC, Drug Product

📋 Description

• Oversee technical activities at drug product CDMOs including clinical trial material (CTM)
• Provide technical and scientific direction to CDMOs and external laboratories to ensure project
• Responsible for technical leadership in issue resolution with CDMOs, including formulation
• Lead the development/optimization of scalable, efficient, and cost-effective processes to produce
• Lead process validation activities and strategies including establishing and evaluating process
• Oversee the preparation of manufacturing batch records, technical reports, data summaries and CMC

🎯 Requirements

• PhD in chemistry, pharmaceutical sciences, or related field preferred; 12+ years of relevant
• Ability to communicate effectively with CRO/CDMO/CMO regarding project scope, scientific results
• Experience managing CDMO from cell line development to successful IND/FIH
• Knowledge of analytical methods for biologics: HPLC, CE-SDS, icIEF, LC-MS, SEC, particle analysis
• Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices
• Knowledge and direct experience with CMC regulatory requirements for IND and NDA/MAA filing

🎁 Benefits

• Market-leading compensation
• 401(k) with employer match
• Employee Stock Purchase Program (ESPP)
• Pre-tax commuter benefits (transit and parking)
• Referral bonus for hired candidates
• Subsidized lunch and parking on in-office days