Associate Director, Technical Operations (Small Molecule CMC)

About the role

The Associate Director, Technical Operations (Small Molecule CMC) will oversee API development and manufacturing for small molecule drug products at Travere CDMOs. This role supports product development, clinical manufacturing, commercial launch planning, logistics, and lifecycle management.

Responsibilities

• Provide technical oversight of API production, scale up, process characterization, and PPQ.
• Review and approve manufacturing-related documentation, including change notifications, batch records, process development, tech transfer, process characterization, and validation protocols/reports.
• Verify suitability, qualification, and validation status of processes at CDMOs and other external laboratories.
• Support GMP quality management systems, including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections.
• Collaborate with internal and external project teams to support CMC development, clinical supply, commercialization, and lifecycle management of small molecule drug products.
• Author and review technical documents and regulatory submission content, including INDs, IMPDs, and NDAs.
• Maintain up-to-date knowledge of US and EU GMP requirements, ICH guidelines, and other regulatory expectations.
• Review project scope, timelines, and deliverables to ensure CDMO activities meet contractual obligations, quality standards, and program objectives.

Requirements

• Bachelor's degree in chemistry, biochemistry, pharmaceutical science, chemical engineering, or related Life Sciences discipline required. Master's or PhD degree preferred.
• 8+ years of relevant experience, with emphasis on late-phase clinical development, scale-up, and commercialization.
• Expert knowledge in process development, characterization studies, PPQ, and commercialization of small molecule APIs for solid oral dosage formulations.
• Demonstrated experience managing and providing technical oversight of CDMOs and contract testing labs, preferably across global manufacturing and testing sites.
• 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.

Additional Skills/Experience

• Strong professional experience in a similar role within the pharmaceutical industry, preferably in small molecule development and manufacturing for solid oral dosage forms.
• Successful record of creating and managing complex project plans, timelines, budgets, and development of risk mitigation strategies.
• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Team player and strong interpersonal and organizational skills with excellent verbal and written communication skills.
• Excellent decision-making and collaboration skills with strong attention to detail.
• Six Sigma and statistical knowledge is a plus.