Associate Director, Technical Operations CMC Strategy
Travere Therapeutics
June 26, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Operations
Position Summary:
The Associate Director, Technical Operations CMC Strategy is responsible for the creation and execution of the CMC strategy for a diverse portfolio of small molecules in development, ensuring test article and study drug are developed and manufactured on time, within budget and scope.
Responsibilities:
- Provide strategic and technical leadership for technology transfer, scale-up, and cGMP manufacturing (Phase I–III clinical and commercial), resolving technical issues.
- Oversee formulation development of approved drugs and new drug candidates.
- Manage and provide technical oversight of formulation development and cGMP manufacturing at contract manufacturing organizations (CMOs).
- Create integrated CMC development plans, timelines, budgets, risk assessments, and mitigation strategies.
- Manage CMOs to develop and maintain methods for clinical/commercial finished dosage form production.
- Review/approve technical and GMP documentation (specifications, Master Batch records, validation documents, 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 to align CMC with goals.
- Support regulatory inspections, partner audits, and ongoing cGMP/global regulatory compliance.
- Provide technical leadership, mentorship, and strategic guidance across teams.
- Support launch readiness and commercialization planning for reliable supply.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences/Chemistry/Pharmaceutical Sciences/Biochemistry/Chemical Engineering or related.
- 8+ years in cGMP CMC drug development/manufacturing (late-phase development, scale-up, commercialization).
- Expert small-molecule API CMC experience (process development through process characterization, PPQ, commercialization, tech transfer) for solid oral dosage forms.
- Leadership experience across CMC areas; small-molecule (oral/injectable), peptides, and biologics experience preferred.
- Extensive experience managing global CMOs, third-party manufacturers, and testing labs.
- Knowledge of phase-appropriate cGMP requirements and US/EU/ICH guidelines.
- Ability to prepare/review CMC sections for IND/IMPD/NDA.
- Manufacturing experience with oral solid dosage forms.
- Expert process validation and technology transfer procedures.
Additional Skills/Experience:
- Courage, community spirit, patient focus, teamwork.
- Flexibility to adapt to project plan changes.
- Strong interpersonal, organizational, verbal/written communication, decision-making, collaboration, and attention to detail.
- Six Sigma/statistical knowledge (plus).
- Travel 10–20% domestically/internationally; not 100% remote.
Benefits (as stated):
- Premium health and wellness offerings, life insurance, disability, retirement with match, and generous paid time off.
Compensation (as stated):
- Target base pay range: $150,000–$195,000.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.
The Associate Director, Technical Operations CMC Strategy is responsible for the creation and execution of the CMC strategy for a diverse portfolio of small molecules in development, ensuring test article and study drug are developed and manufactured on time, within budget and scope.
Responsibilities:
- Provide strategic and technical leadership for technology transfer, scale-up, and cGMP manufacturing (Phase I–III clinical and commercial), resolving technical issues.
- Oversee formulation development of approved drugs and new drug candidates.
- Manage and provide technical oversight of formulation development and cGMP manufacturing at contract manufacturing organizations (CMOs).
- Create integrated CMC development plans, timelines, budgets, risk assessments, and mitigation strategies.
- Manage CMOs to develop and maintain methods for clinical/commercial finished dosage form production.
- Review/approve technical and GMP documentation (specifications, Master Batch records, validation documents, 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 to align CMC with goals.
- Support regulatory inspections, partner audits, and ongoing cGMP/global regulatory compliance.
- Provide technical leadership, mentorship, and strategic guidance across teams.
- Support launch readiness and commercialization planning for reliable supply.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences/Chemistry/Pharmaceutical Sciences/Biochemistry/Chemical Engineering or related.
- 8+ years in cGMP CMC drug development/manufacturing (late-phase development, scale-up, commercialization).
- Expert small-molecule API CMC experience (process development through process characterization, PPQ, commercialization, tech transfer) for solid oral dosage forms.
- Leadership experience across CMC areas; small-molecule (oral/injectable), peptides, and biologics experience preferred.
- Extensive experience managing global CMOs, third-party manufacturers, and testing labs.
- Knowledge of phase-appropriate cGMP requirements and US/EU/ICH guidelines.
- Ability to prepare/review CMC sections for IND/IMPD/NDA.
- Manufacturing experience with oral solid dosage forms.
- Expert process validation and technology transfer procedures.
Additional Skills/Experience:
- Courage, community spirit, patient focus, teamwork.
- Flexibility to adapt to project plan changes.
- Strong interpersonal, organizational, verbal/written communication, decision-making, collaboration, and attention to detail.
- Six Sigma/statistical knowledge (plus).
- Travel 10–20% domestically/internationally; not 100% remote.
Benefits (as stated):
- Premium health and wellness offerings, life insurance, disability, retirement with match, and generous paid time off.
Compensation (as stated):
- Target base pay range: $150,000–$195,000.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.