Hiring: Sr. Director/ Exec. Director- CMC, Drug Product Company: BridgeBio Location: San Francisco, CA Job Posted Time: 2026-09-16 11:47:39 Employment Type: Full-time / Hybrid Target Skills & Keywords : GCP About the job Experience: •12+ years of relevant industry experience (8+ years focused on antibodies) Required Skills: •Oversee technical activities at drug product CDMOs including clinical trial material (CTM) production, process troubleshooting, risk assessments, registration batch production, and process validation •Provide technical and scientific direction to CDMOs and external laboratories to ensure project deadlines and performance standards are met •Lead and oversee technical leadership in issue resolution with CDMOs, including formulation challenges, technical transfer, design of experiments, and interpretation of results •Lead the development/optimization of scalable, efficient, and cost-effective processes to produce CTM while ensuring product quality •Lead process validation activities and strategies including establishing and evaluating process characterization plans, overseeing execution at CDMO, reviewing and approving CDMO reports •Oversee the preparation of manufacturing batch records, technical reports, data summaries and CMC related documents required for various regulatory submissions •Coordinate with Quality and Supply Chain teams to ensure timely manufacture and release of drug product lots by leading technical reviews of batch records, deviations, change controls, and nonconformance investigations; proactively identify and mitigate risks related to clinical supply •Manage related SOPs, change controls, deviations and CAPAs with thorough knowledge of Good Manufacturing Practices Qualifications: •PhD in chemistry, pharmaceutical sciences, or related field preferred; 12+ years of relevant industry experience (8+ years focused on antibodies) Compensation: •$260,000 - $278,100 / year •Flexible work environment (work from home / hybrid options) •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!