Associate Director, Technical Operations (Small Molecule CMC)

Location: Remote – US-based candidates only, no visa sponsorship available

About the role

This role will lead operational priorities where safety, quality, compliance, and execution discipline are central to success. You will collaborate with field leadership, support functions, and cross-functional stakeholders to improve accountability, service delivery, and operational consistency. The position offers the opportunity to influence operational scale, customer outcomes, and organizational performance within a life sciences environment.

Responsibilities

• Oversee API production, scale-up, and process qualification for small molecule drug products at CDMOs
• Review and approve manufacturing documentation and change notifications
• Verify qualification status and suitability of processes at CDMOs and labs
• Support GMP quality systems, ensuring compliance during inspections and submissions
• Collaborate with project teams on CMC development and lifecycle management of drug products
• Author and review regulatory submission documents and technical documents
• Ensure CDMO activities meet quality standards and contractual obligations

Qualifications

• B.S. in chemistry, biochemistry, pharmaceutical science, chemical engineering, or related field required; M.S. or Ph.D preferred
• 8+ years of experience in late-phase clinical development and commercialization of small molecule APIs
• Expert knowledge in process development, characterization studies, and production of solid oral dosage forms
• Experience managing CDMO operations and technical oversight across global sites
• Broad knowledge of phase-appropriate cGMP requirements and US/EU regulatory guidelines
• Experience in preparing and reviewing regulatory filings like INDs and NDAs

Pay

$150,000 – $195,000 annually

Benefits

• Comprehensive health, financial, work-life, and well-being offerings
• Wellness and employee support programs
• Life insurance and disability benefits
• Retirement plans with employer matching contributions
• Generous paid time off for employees and dependents