Job Details
Posted 16 July, 2026
Job Id: 628995
Director, Technical Operations (Remote)
Job Description
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
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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