Associate Director, Technical Operations - Drug Product
Travere Therapeutics
August 08, 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. Manages external CDMOs and collaborates with Technical Operations, Quality, Regulatory CMC, Clinical, and Supply Chain.
Responsibilities:
- Technical oversight of production, scale up, process characterization, and process performance qualification (PPQ) of 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 knowledge of US/EU GMPs and applicable regulatory guidance.
- Ensure CDMO contractual scope meets quality standards/timelines.
- Recommend strategies to leadership regarding CDMO performance, process readiness, validation strategy, regulatory risks, and commercialization milestones.
Education/Experience Requirements:
- Bachelor’s degree required (Chemistry/Pharma Sciences/Biochemistry/Chemical Engineering or related); M.S./Ph.D. preferred.
- 8+ years relevant experience in small molecule drug product manufacturing (scale-up, late phase, commercialization).
- Experience with amorphous solid dispersions (spray dried preferred); solid oral product development (granulation, capsules/tablets) a plus.
- Expert knowledge of process development/characterization/PPQ; CMC modules for IND/IMPD/NDA.
- Extensive experience managing global CDMOs/third-party manufacturers and testing labs.
- Knowledge of phase-appropriate cGMP and US/EU/ICH guidelines.
Additional Skills/Experience:
- Courage, Community Spirit, Patient Focus, Teamwork.
- Strong project planning, risk mitigation, communication, decision-making, and collaboration; Six Sigma/statistics a plus.
- Travel 10–20% and onsite/face-to-face work in San Diego (not 100% remote).
Benefits:
- Premium health and other work-life/well-being offerings, life insurance, disability, retirement match, generous paid time off.
Compensation:
- Target base pay range: $150,000–$195,000.
Application Instructions:
- Travere accepts applications on an ongoing basis until a candidate is selected.
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. Manages external CDMOs and collaborates with Technical Operations, Quality, Regulatory CMC, Clinical, and Supply Chain.
Responsibilities:
- Technical oversight of production, scale up, process characterization, and process performance qualification (PPQ) of 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 knowledge of US/EU GMPs and applicable regulatory guidance.
- Ensure CDMO contractual scope meets quality standards/timelines.
- Recommend strategies to leadership regarding CDMO performance, process readiness, validation strategy, regulatory risks, and commercialization milestones.
Education/Experience Requirements:
- Bachelor’s degree required (Chemistry/Pharma Sciences/Biochemistry/Chemical Engineering or related); M.S./Ph.D. preferred.
- 8+ years relevant experience in small molecule drug product manufacturing (scale-up, late phase, commercialization).
- Experience with amorphous solid dispersions (spray dried preferred); solid oral product development (granulation, capsules/tablets) a plus.
- Expert knowledge of process development/characterization/PPQ; CMC modules for IND/IMPD/NDA.
- Extensive experience managing global CDMOs/third-party manufacturers and testing labs.
- Knowledge of phase-appropriate cGMP and US/EU/ICH guidelines.
Additional Skills/Experience:
- Courage, Community Spirit, Patient Focus, Teamwork.
- Strong project planning, risk mitigation, communication, decision-making, and collaboration; Six Sigma/statistics a plus.
- Travel 10–20% and onsite/face-to-face work in San Diego (not 100% remote).
Benefits:
- Premium health and other work-life/well-being offerings, life insurance, disability, retirement match, generous paid time off.
Compensation:
- Target base pay range: $150,000–$195,000.
Application Instructions:
- Travere accepts applications on an ongoing basis until a candidate is selected.