Position Summary The Director Technical Operations (Small Molecule CMC) will provide technical oversight for small molecule API development and manufacturing activities conducted at CDMOs. Serving as a key technical point of contact 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 collaborate 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 including ability to help drive CMC strategy for a late-stage development asset. 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 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. Education/Experience Requirements Bachelor’s degree in Life Sciences Chemistry Pharmaceutical Sciences Biochemistry Chemical Engineering or a related discipline required. Equivalent combination of education and applicable job experience may be considered M.S. Ph.D. or other advanced degree in a related discipline preferred 10+ years of relevant experience (depending on degree) in small molecule API development and manufacturing with emphasis on late-phase clinical development scale-up and commercialization Expert knowledge and extensive CMC experience advancing small molecule APIs from process development through process characterization PPQ commercialization and tech transfers in support of solid oral dosage form programs Extensive experience managing global CDMOs third-party manufacturers and testing labs. 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