Associate Director, Technical Operations, Biologics Drug Substance Manufacturing
Travere Therapeutics
August 08, 2026
Remote friendly (United States)
United States
Operations
Position Summary:
Associate Director, Technical Operations (Biologics Drug Substance Manufacturing) provides technical expertise and operational leadership for biologic drug substance manufacturing from late-stage clinical development through commercialization. Partners with Technical Operations, Quality, and Regulatory Affairs on manufacturing processes and validation activities at external Contract Development and Manufacturing Organizations (CDMOs), with deep expertise in microbial fermentation and downstream production.
Responsibilities:
- Provide downstream technical oversight for drug substance manufacturing supporting late-stage clinical and commercial biologics at CDMOs.
- Review/approve manufacturing documents: change notifications, batch records, process development, tech transfer, process characterization (PC), PPQ protocols/reports.
- Support GMP quality systems: deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections.
- Monitor process performance, identify trends, and recommend improvements for robustness, quality, and efficiency.
- Support tech transfer and process scale-up at CDMOs.
- Partner with Regulatory Affairs on CMC documentation for IND/BLA and agency responses.
- Author technical manufacturing reports.
- Support lifecycle management (process optimization, post-approval changes, CPV).
Qualifications:
- Bachelor’s in Life Sciences/Chemistry/Pharmaceutical Sciences/Biochemistry/Chemical Engineering or related (advanced degree preferred).
- 8+ years in biologics manufacturing, scale-up, and late-stage development/commercialization.
Required/Preferred Skills:
- Microbial fermentation and downstream processing expertise (PEGylation a plus).
- QbD; experience supporting PPQ/process validation.
- Experience preparing/supporting BLA CMC manufacturing sections.
- Knowledge of US/EU cGMP, FDA/ICH guidance, tech transfer, validation, lifecycle management.
- Experience with external CDMOs; statistical process monitoring, process characterization, quality risk tools; troubleshooting; strong technical writing.
- Travel 20–25% and ability to work onsite in San Diego; not 100% remote.
Benefits/Compensation:
- Benefits: premium health/financial/work-life/well-being offerings, wellness/support programs, life insurance, disability, retirement with match, and generous paid time off.
- Target base pay range: $150,000–$195,000.
Application Instructions:
- Applications are accepted on an ongoing basis until a candidate is selected.
Associate Director, Technical Operations (Biologics Drug Substance Manufacturing) provides technical expertise and operational leadership for biologic drug substance manufacturing from late-stage clinical development through commercialization. Partners with Technical Operations, Quality, and Regulatory Affairs on manufacturing processes and validation activities at external Contract Development and Manufacturing Organizations (CDMOs), with deep expertise in microbial fermentation and downstream production.
Responsibilities:
- Provide downstream technical oversight for drug substance manufacturing supporting late-stage clinical and commercial biologics at CDMOs.
- Review/approve manufacturing documents: change notifications, batch records, process development, tech transfer, process characterization (PC), PPQ protocols/reports.
- Support GMP quality systems: deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections.
- Monitor process performance, identify trends, and recommend improvements for robustness, quality, and efficiency.
- Support tech transfer and process scale-up at CDMOs.
- Partner with Regulatory Affairs on CMC documentation for IND/BLA and agency responses.
- Author technical manufacturing reports.
- Support lifecycle management (process optimization, post-approval changes, CPV).
Qualifications:
- Bachelor’s in Life Sciences/Chemistry/Pharmaceutical Sciences/Biochemistry/Chemical Engineering or related (advanced degree preferred).
- 8+ years in biologics manufacturing, scale-up, and late-stage development/commercialization.
Required/Preferred Skills:
- Microbial fermentation and downstream processing expertise (PEGylation a plus).
- QbD; experience supporting PPQ/process validation.
- Experience preparing/supporting BLA CMC manufacturing sections.
- Knowledge of US/EU cGMP, FDA/ICH guidance, tech transfer, validation, lifecycle management.
- Experience with external CDMOs; statistical process monitoring, process characterization, quality risk tools; troubleshooting; strong technical writing.
- Travel 20–25% and ability to work onsite in San Diego; not 100% remote.
Benefits/Compensation:
- Benefits: premium health/financial/work-life/well-being offerings, wellness/support programs, life insurance, disability, retirement with match, and generous paid time off.
- Target base pay range: $150,000–$195,000.
Application Instructions:
- Applications are accepted on an ongoing basis until a candidate is selected.