Associate Director, Technical Operations - Drug Product
Travere Therapeutics
August 29, 2026
Remote friendly (United States)
United States
Operations
Position Summary:
The Associate Director, Technical Operations – Drug Product, is responsible for drug product manufacturing, scale up, validation, and commercialization of a small molecule, solid oral drug product. Key CMC contributor from clinical development through commercialization, managing external CDMOs and collaborating with Technical Operations, Quality, Regulatory CMC, Clinical, and Supply Chain.
Responsibilities:
- Provide technical oversight of production, scale up, process characterization, and PPQ for solid oral small molecule drug product manufacturing at CDMOs.
- Review/approve manufacturing documents (change notifications, batch records, process development, tech transfer, process characterization, validation protocols/reports).
- Verify suitability, qualification, and validation of processes at CDMOs and external labs.
- Support GMP quality systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections).
- Collaborate on CMC development and commercialization with internal/external teams.
- Author/review technical documents and regulatory filings (INDs, IMPDs, NDAs).
- Maintain current knowledge of US/EU GMP and applicable regulatory guidance.
- Ensure CDMO contracts meet quality standards and timelines; recommend on CDMO performance, readiness, validation strategy, regulatory risks, and milestones.
Education/Experience (Required/Preferred):
- Required: Bachelor’s in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related.
- Preferred: M.S./Ph.D. in Chemical/ Biomedical/ Biomedical Eng., Biotechnology, Biochemistry, or related.
- 8+ years in small molecule drug product manufacturing (scale-up, late phase clinical, commercialization).
- Preferred experience: amorphous solid dispersions (spray dried), plus solid oral (granulation, capsules, tablets).
- Expert knowledge in process development, characterization, PPQ, and commercialization for solid oral products.
- Skilled in CMC modules for IND/IMPD/NDA; extensive CDMO/third-party manufacturer and testing lab management; knowledge of phase-appropriate cGMP and US/EU/ICH guidelines.
Additional Skills:
- Courage, community spirit, patient focus, teamwork; strong interpersonal/organizational skills and verbal/written communication.
- Risk mitigation, complex project management, adaptability to change; decision-making/collaboration with attention to detail.
- Plus: Six Sigma/statistics; travel 10–20%.
- Not 100% remote; must be able to perform face-to-face/onsite work in San Diego.
Benefits (explicitly stated):
- Premium health and financial/work-life/well-being offerings, wellness/support programs, life insurance, disability, retirement with match, generous paid time off.
- Target base pay range: $150,000.00–$195,000.00.
Application Instructions:
- Applications accepted on an ongoing basis until a candidate is selected for the position.
The Associate Director, Technical Operations – Drug Product, is responsible for drug product manufacturing, scale up, validation, and commercialization of a small molecule, solid oral drug product. Key CMC contributor from clinical development through commercialization, managing external CDMOs and collaborating with Technical Operations, Quality, Regulatory CMC, Clinical, and Supply Chain.
Responsibilities:
- Provide technical oversight of production, scale up, process characterization, and PPQ for solid oral small molecule drug product manufacturing at CDMOs.
- Review/approve manufacturing documents (change notifications, batch records, process development, tech transfer, process characterization, validation protocols/reports).
- Verify suitability, qualification, and validation of processes at CDMOs and external labs.
- Support GMP quality systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections).
- Collaborate on CMC development and commercialization with internal/external teams.
- Author/review technical documents and regulatory filings (INDs, IMPDs, NDAs).
- Maintain current knowledge of US/EU GMP and applicable regulatory guidance.
- Ensure CDMO contracts meet quality standards and timelines; recommend on CDMO performance, readiness, validation strategy, regulatory risks, and milestones.
Education/Experience (Required/Preferred):
- Required: Bachelor’s in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related.
- Preferred: M.S./Ph.D. in Chemical/ Biomedical/ Biomedical Eng., Biotechnology, Biochemistry, or related.
- 8+ years in small molecule drug product manufacturing (scale-up, late phase clinical, commercialization).
- Preferred experience: amorphous solid dispersions (spray dried), plus solid oral (granulation, capsules, tablets).
- Expert knowledge in process development, characterization, PPQ, and commercialization for solid oral products.
- Skilled in CMC modules for IND/IMPD/NDA; extensive CDMO/third-party manufacturer and testing lab management; knowledge of phase-appropriate cGMP and US/EU/ICH guidelines.
Additional Skills:
- Courage, community spirit, patient focus, teamwork; strong interpersonal/organizational skills and verbal/written communication.
- Risk mitigation, complex project management, adaptability to change; decision-making/collaboration with attention to detail.
- Plus: Six Sigma/statistics; travel 10–20%.
- Not 100% remote; must be able to perform face-to-face/onsite work in San Diego.
Benefits (explicitly stated):
- Premium health and financial/work-life/well-being offerings, wellness/support programs, life insurance, disability, retirement with match, generous paid time off.
- Target base pay range: $150,000.00–$195,000.00.
Application Instructions:
- Applications accepted on an ongoing basis until a candidate is selected for the position.