Associate Director, Technical Operations CMC Strategy

Role Overview:

• Lead the creation and execution of CMC strategy for a diverse portfolio of small molecules in development.
• Ensure test article and study drug are developed and manufactured on time, within budget and scope.
• Provide strategic and technical leadership for technology transfer, scale-up, and cGMP manufacturing activities.

Key Responsibilities:

• Oversee formulation development of current approved drugs and new drug candidates.
• Manage and provide technical oversight of CMOs for clinical/commercial production.
• Author, edit, and review CMC sections of regulatory submissions, including INDs, IMPDs, and NDAs.

Qualifications:

• Bachelor’s degree in Life Sciences, Chemistry, or related discipline with 8+ years of relevant CMC experience.
• Expert knowledge in small molecule API development, process characterization, and commercialization.
• Extensive experience managing global CMOs and third-party manufacturers.

Total Rewards:

• Competitive compensation package including base pay, short-term incentive, and long-term incentive (company stock).
• Comprehensive benefits including premium health, financial, and well-being offerings.
• Generous paid time off and retirement plans with employer match.