Job Details

Position Summary:
The Associate Director, Technical Operations (Small Molecule CMC) will provide technical oversight for small molecule API development and manufacturing activities conducted at company CDMOs. This role is a critical contributor within Technical Operations (CMC) and broadly supports the product development, clinical manufacturing, commercial launch planning, logistics, and lifecycle management of small molecule drug products.
This individual will partner closely with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment, risk management, and successful achievement of program milestones. The successful candidate will bring substantial experience in small molecule API development and manufacturing, appropriate for advancing a late-stage development asset to commercial readiness.
Responsibilities:

• Provide technical oversight of API production, scale up, process characterization, and process performance qualification (PPQ) for a small molecule, solid oral drug product manufactured at company CDMOs.
• 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.
• Provide technical support for 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 applicable to pharmaceutical development and manufacturing.
• Review project scope, timelines, and deliverables to ensure CDMO activities meet contractual obligations, quality standards, and program objectives.
• Additional duties assigned as needed.

Education/Experience Requirements:  

• B.S. degree in chemistry, biochemistry, pharmaceutical science, chemical engineering, or related Life Sciences discipline required. M.S. or Ph.D degree preferred. Equivalent combination of education and applicable job experience may be considered.
• 8+ years of relevant experience required 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.