Associate Director, Technical Operations - Drug Product
Travere Therapeutics
August 08, 2026
Remote friendly (San Diego Metropolitan Area)
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:
- Provide technical oversight of production, scale up, process characterization, and PPQ of drug product manufacture 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.
- Author/review technical documents and regulatory filings (INDs, IMPDs, NDAs).
- Maintain knowledge of US/EU GMPs and applicable regulatory guidance.
- Ensure CDMO contractual obligations meet quality standards and timelines; recommend strategy based on CDMO performance, process readiness, validation strategy, risks, and milestones.
Education/Experience Requirements:
- Bachelor’s degree required; advanced degree preferred.
- 8+ years relevant experience in small molecule drug product manufacturing (scale-up, late phase clinical, commercialization).
- Experience with amorphous solid dispersions (spray dried preferred); solid oral (granulation, capsules/tablets) plus.
- Expert in process development/characterization, PPQ, and commercialization for solid oral products (focus on amorphous solid dispersions).
- Experience preparing CMC modules for INDs/IMPDs/NDAs; manage global CDMOs/third-party manufacturers/testing labs.
- Knowledge of phase-appropriate cGMP and US/EU/ICH guidelines.
Additional Skills/Experience:
- Strong teamwork, communication, organizational skills; attention to detail.
- Record managing complex plans/timelines/budgets and risk mitigation; flexibility with changing plans.
- Six Sigma/statistical knowledge plus.
- Travel 10–20% and ability to work onsite in San Diego (not 100% remote).
Benefits:
- Premium health, financial, work-life/well-being, wellness/support programs, life insurance, disability, retirement match, and generous paid time off.
- 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:
- Provide technical oversight of production, scale up, process characterization, and PPQ of drug product manufacture 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.
- Author/review technical documents and regulatory filings (INDs, IMPDs, NDAs).
- Maintain knowledge of US/EU GMPs and applicable regulatory guidance.
- Ensure CDMO contractual obligations meet quality standards and timelines; recommend strategy based on CDMO performance, process readiness, validation strategy, risks, and milestones.
Education/Experience Requirements:
- Bachelor’s degree required; advanced degree preferred.
- 8+ years relevant experience in small molecule drug product manufacturing (scale-up, late phase clinical, commercialization).
- Experience with amorphous solid dispersions (spray dried preferred); solid oral (granulation, capsules/tablets) plus.
- Expert in process development/characterization, PPQ, and commercialization for solid oral products (focus on amorphous solid dispersions).
- Experience preparing CMC modules for INDs/IMPDs/NDAs; manage global CDMOs/third-party manufacturers/testing labs.
- Knowledge of phase-appropriate cGMP and US/EU/ICH guidelines.
Additional Skills/Experience:
- Strong teamwork, communication, organizational skills; attention to detail.
- Record managing complex plans/timelines/budgets and risk mitigation; flexibility with changing plans.
- Six Sigma/statistical knowledge plus.
- Travel 10–20% and ability to work onsite in San Diego (not 100% remote).
Benefits:
- Premium health, financial, work-life/well-being, wellness/support programs, life insurance, disability, retirement match, and generous paid time off.
- Target base pay range: $150,000–$195,000.
Application Instructions:
- Travere accepts applications on an ongoing basis until a candidate is selected.