Associate Director, Technical Operations CMC Strategy

Responsibilities

• Lead technology transfer, scale-up, and cGMP manufacturing activities
• Oversee formulation development for approved drugs and new candidates
• Manage technical oversight at CMOs for cGMP production
• Develop integrated CMC plans, timelines, budgets, and risk assessments
• Manage CMOs to optimize clinical/commercial production methods
• Review and approve GMP documentation and technical reports
• Contribute to CMC sections of regulatory submissions

Qualifications

• Bachelor's degree in Life Sciences or related field; equivalent experience considered
• 8+ years in cGMP CMC drug development and manufacturing, focusing on late-phase
• Expertise in advancing small molecule APIs from development to commercialization
• Leadership experience across multiple CMC areas and drug types (small molecules, peptides, biologics)
• Experience managing global contract manufacturing organizations (CMOs) and testing labs
• Knowledge of cGMP requirements, US, EU, and ICH guidelines
• Ability to prepare CMC sections for regulatory filings

Benefits

• Premium health coverage and financial offerings for employees and dependents
• Wellness programs and employee support
• Life insurance and disability benefits
• Retail plans with employer match
• Generous paid time off