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

BridgeBio Pharma seeks a senior director or executive director for Chemistry, Manufacturing, and Controls (CMC) of drug products. The role oversees technical activities at contract manufacturers, leads process development and validation, and ensures regulatory compliance for clinical and commercial manufacturing.

Responsibilities

• Oversee technical activities at CDMOs including clinical trial material production, process troubleshooting, and registration batch production
• Provide technical and scientific direction to CDMOs and laboratories to meet project deadlines and performance standards
• Lead process development, optimization, and validation activities including characterization plans and design of experiments
• Manage CMC documentation and regulatory submissions including INDs, IMPDs, and NDA/MAA applications
• Coordinate with Quality and Supply Chain teams on batch record reviews, deviations, change controls, and risk mitigation

Requirements

• PhD in chemistry, pharmaceutical sciences, or related field preferred
• 12+ years industry experience with 8+ years focused on antibodies
• Experience managing contract manufacturers from cell line development through IND submission
• Knowledge of analytical methods for biologics including HPLC, CE-SDS, icIEF, LC-MS, SEC, particle analysis, DSC
• Effective communication skills with external partners regarding project scope and results
• Strong knowledge of GMP, regulatory requirements, and CMC documentation