Job Details

Position Summary:
The Associate Director, Technical Operations CMC Strategy is responsible for the creation and execution of the CMC strategy for a diverse portfolio of small molecules in development, ensuring test article and study drug are developed and manufactured on time, within budget & scope.
 
This individual will collaborate closely with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment, risk management, and successful achievement of program milestones. The successful candidate will bring substantial experience in small molecule API development and manufacturing, including an ability to drive CMC strategy for a late-stage development asset.
 
Responsibilities:

• Provide strategic and technical leadership for technology transfer, scale-up, and cGMP manufacturing activities, ensuring timely resolution of technical issues across Phase I-III clinical and commercial products.
• Oversee formulation development of current approved drugs and new drug candidates.
• Manage and provide technical oversight of formulation development and cGMP manufacturing activities at contract manufacturing organizations (CMOs).
• Support creation of integrated CMC development plans, timelines, budgets, risk assessments, and mitigation strategies to support clinical and commercial milestones.
• Managing CMOs to develop and maintain methods for clinical/commercial production of finished dosage forms
• Review and approve technical and GMP documentation, including specifications, Master Batch records, validation documents, change controls, and technical reports.
• Author, edit, review, and contribute to CMC sections of regulatory submissions, responses, and health authority interactions.
• Partner closely with Regulatory Affairs, Quality, Supply Chain, Clinical Operations, and Program Management to ensure alignment of CMC activities with development and commercialization goals.
• Support regulatory inspections, partner audits, and ongoing compliance with applicable cGMP and global regulatory requirements.
• Provide technical leadership, mentorship, and strategic guidance across Technical Operations and cross-functional teams.
• Support launch readiness and commercialization planning to ensure reliable product supply.

 
Education/Experience Requirements:  

• Bachelor’s degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related discipline required.  Equivalent combination of education and applicable job experience may be considered
• 8+ years of relevant experience in cGMP related CMC drug development and manufacturing with emphasis on late-phase clinical development, scale-up, and commercialization
• Expert knowledge and extensive CMC experience advancing small molecule APIs from process development through process characterization, PPQ, commercialization, and tech transfers in support of solid oral dosage form programs
• Demonstrated leadership experience in CMC: preferably in more than one related CMC area, and drug development experience with small molecules (both oral and injectable), peptides, and biologics of varying degrees of complexity
• Extensive experience managing global CMOs, third-party manufacturers, and testing labs.
• Broad knowledge and experience with phase-appropriate cGMP requirements and applicable US, EU, and ICH guidelines
• Demonstrated ability to prepare and review CMC sections of regulatory filings, including INDs, IMPDs, and NDAs
• Manufacturing experience with oral solid dosage forms
• Expert knowledge in process validation and technology transfer procedures