Associate Director, Technical Operations CMC Strategy
Travere Therapeutics
June 26, 2026
Remote friendly (United States)
United States
Operations
Position Summary:
Associate Director, Technical Operations CMC Strategy responsible for creating and executing the CMC strategy for a diverse portfolio of small molecules in development to ensure test article and study drug are developed and manufactured on time, within budget and scope.
Responsibilities:
- Provide strategic/technical leadership for technology transfer, scale-up, and cGMP manufacturing; resolve technical issues across Phase I–III and commercial.
- Oversee formulation development of approved drugs and new candidates.
- Manage/oversee formulation development and cGMP manufacturing at CMOs.
- Develop integrated CMC plans (timelines, budgets, risk assessments, mitigations) for clinical/commercial milestones.
- Manage CMOs for methods for clinical/commercial finished dosage forms.
- Review/approve GMP and technical documents (specifications, Master Batch records, validation, change controls, technical reports).
- Author/review CMC sections of regulatory submissions and responses.
- Partner with Regulatory Affairs, Quality, Supply Chain, Clinical Operations, and Program Management.
- Support regulatory inspections and partner audits; maintain cGMP compliance.
- Provide technical leadership, mentorship, and guidance across Technical Operations.
- Support launch readiness and commercialization planning.
Qualifications/Experience:
- Bachelor’s in Life Sciences/Chemistry/Pharmaceutical Sciences/Biochemistry/Chemical Engineering (or related); or equivalent.
- 8+ years cGMP CMC drug development/manufacturing (late-phase, scale-up, commercialization).
- Expert small-molecule API experience (process development through PPQ, commercialization, tech transfers) for solid oral dosage forms.
- Leadership experience in CMC (including multiple areas); experience with small molecules (oral/injectable), peptides/biologics.
- Experience managing global CMOs, manufacturers, and testing labs.
- Knowledge of phase-appropriate cGMP and US/EU/ICH guidelines.
- Ability to prepare/review CMC sections for IND/IMPD/NDA.
- Oral solid dosage form manufacturing; process validation and technology transfer procedures.
Additional/Preferred Skills:
- Courage, community spirit, patient focus, teamwork.
- Strong communication/organization; decision-making and collaboration; detail-oriented.
- Six Sigma/statistical knowledge (plus).
- Travel 10–20%.
- Onsite presence in San Diego required; not fully remote.
Benefits/Compensation (if applicable):
- Benefits include premium health, life insurance, disability, retirement with match, and generous paid time off.
- Target base pay: $150,000–$195,000.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.
Associate Director, Technical Operations CMC Strategy responsible for creating and executing the CMC strategy for a diverse portfolio of small molecules in development to ensure test article and study drug are developed and manufactured on time, within budget and scope.
Responsibilities:
- Provide strategic/technical leadership for technology transfer, scale-up, and cGMP manufacturing; resolve technical issues across Phase I–III and commercial.
- Oversee formulation development of approved drugs and new candidates.
- Manage/oversee formulation development and cGMP manufacturing at CMOs.
- Develop integrated CMC plans (timelines, budgets, risk assessments, mitigations) for clinical/commercial milestones.
- Manage CMOs for methods for clinical/commercial finished dosage forms.
- Review/approve GMP and technical documents (specifications, Master Batch records, validation, change controls, technical reports).
- Author/review CMC sections of regulatory submissions and responses.
- Partner with Regulatory Affairs, Quality, Supply Chain, Clinical Operations, and Program Management.
- Support regulatory inspections and partner audits; maintain cGMP compliance.
- Provide technical leadership, mentorship, and guidance across Technical Operations.
- Support launch readiness and commercialization planning.
Qualifications/Experience:
- Bachelor’s in Life Sciences/Chemistry/Pharmaceutical Sciences/Biochemistry/Chemical Engineering (or related); or equivalent.
- 8+ years cGMP CMC drug development/manufacturing (late-phase, scale-up, commercialization).
- Expert small-molecule API experience (process development through PPQ, commercialization, tech transfers) for solid oral dosage forms.
- Leadership experience in CMC (including multiple areas); experience with small molecules (oral/injectable), peptides/biologics.
- Experience managing global CMOs, manufacturers, and testing labs.
- Knowledge of phase-appropriate cGMP and US/EU/ICH guidelines.
- Ability to prepare/review CMC sections for IND/IMPD/NDA.
- Oral solid dosage form manufacturing; process validation and technology transfer procedures.
Additional/Preferred Skills:
- Courage, community spirit, patient focus, teamwork.
- Strong communication/organization; decision-making and collaboration; detail-oriented.
- Six Sigma/statistical knowledge (plus).
- Travel 10–20%.
- Onsite presence in San Diego required; not fully remote.
Benefits/Compensation (if applicable):
- Benefits include premium health, life insurance, disability, retirement with match, and generous paid time off.
- Target base pay: $150,000–$195,000.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.