Meet Life Sciences

Compensation

Full Description

Position: Senior / Executive Director, Pharmaceutical Development Location: South San Francisco, CA - 4 days in office/week Reporting to: Vice President Responsibilities • Oversee technical activities at drug product CMOs, including technology transfer, clinical trial material (CTM) production, process troubleshooting, QbD and PAR studies, risk assessments, registration batch production, and process validation • Coordinate with Quality and Global 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 • Partner with Chemical Development and Analytical Development functions to define optimal drug substance properties and control strategies • Ensure adherence to applicable regulations and guidelines, including FDA, EMA, ICH, GCP, and GMP • Provide person-in-plant support for drug product manufacturing • Serve as the drug product subject matter expert for internal program teams, due diligence activities, and CMO selection, management, and audits • Author and review CMC sections of regulatory filings, including INDs, IMPD/IND amendments, and NDA/MAA submissions • Coordinate with Analytical teams to ensure expiry and retest dating are current and aligned with drug product supply and commercialization plans • Contribute to internal and external presentations and publications • Manage, mentor, and develop scientists and engineers Qualifications • Ph.D. in Chemistry, Pharmaceutical Sciences, Engineering, or a related discipline with at least 10 years of late-phase, small-molecule drug product development experience (M.S. with 15+ years considered) • Extensive experience in GMP oral solid dose manufacturing, including spray drying, granulation, hot melt extrusion, tableting, and encapsulation • Demonstrated expertise in formulation development and manufacturing of enabled formulations • Significant experience managing third-party drug product CMOs, including tech transfer, QbD studies, clinical supply production, registration batches, and commercial launch activities • Strong understanding of product/packaging interactions, barrier properties, stability, global packaging regulations, and package testing • In-depth knowledge of cGMP, ICH, FDA, and EMA requirements • Proven ability to collaborate effectively across internal and external stakeholders • Excellent written and verbal communication skills with strong problem-solving capabilities • Ability to manage multiple priorities in a fast-paced environment and navigate complex technical challenges • Willingness to travel up to 25%