Director, Technical Operations

Responsibilities

• Provide technical oversight of API production and scale-up for small molecule drug products
• Review and approve manufacturing-related documents such as change notifications and validation reports
• Verify the qualification status of processes at CDMOs and external labs
• Support GMP quality management systems, including regulatory submissions and inspection preparations
• Collaborate with project teams for CMC development and supply chain alignment
• Author and review technical documents for regulatory submissions
• Ensure CDMO compliance with contractual obligations and quality standards

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related discipline required
• 10+ years of relevant experience in small molecule API development and manufacturing, especially in late-phase clinical development
• Expert knowledge of advancing small molecule APIs through various phases, including commercialization
• Extensive experience managing global CDMOs and third-party manufacturers
• Demonstrated ability to prepare and review CMC sections of regulatory filings

Benefits

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