Associate Director, Technical Operations – CMC Strategy

Role Overview

• 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

Requirements

• Bachelor’s degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related discipline required
• 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

Benefits

• premium health
• financial, work-life and well-being offerings for eligible employees and dependents
• wellness and employee support programs
• life insurance
• disability
• retirement plans with employer match
• generous paid time off