Responsibilities

• 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
• Responsible for 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
• Ensure adherence to applicable regulations and guidelines, including FDA, EMA, ICH, GCP, and GMP
• Author and review CMC sections of regulatory filings, including INDs, IMPD/IND amendments, and NDA/MAA submissions

Education, Experience & Skills Requirements

• PhD in chemistry, pharmaceutical sciences, or related field preferred; 12+ years of relevant industry experience (8+ years focused on antibodies)
• Ability to communicate effectively with CRO/CDMO/CMO regarding project scope, scientific results and project updates
• 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, DSC. Familiarity with characterization of glycoslation, post-translational modifications, and degradation pathways.
• 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
• Proven leadership and team management; ability to drive cross-functional projects under time pressure.
• Excellent written and oral communication skills; comfort presenting to regulatory agencies and CDMOs.
• Self-starter who thrives in a fast-moving environment and can partner effectively with program leadership.