Associate Director, Technical Operations, Biologics Drug Substance Manufacturing
Travere Therapeutics
August 30, 2026
Remote friendly (United States)
United States
Operations
Position Summary:
The Associate Director, Technical Operations, Biologics Drug Substance Manufacturing provides technical expertise and operational leadership/support for biologic drug substance manufacturing from late-stage clinical development through commercialization. Collaborates with Technical Operations, Quality, and Regulatory Affairs on manufacturing processes and validation activities at external CDMOs. Deep technical expertise in microbial fermentation (downstream) with experience supporting late-stage development, PPQ, and BLA submissions.
Responsibilities:
- Provide technical oversight for downstream drug substance manufacturing at CDMOs supporting late-stage clinical and commercial programs.
- Review/approve manufacturing documents (change notifications, batch records, process development, tech transfer, PC and PPQ protocols/reports).
- Serve as technical resource for GMP quality systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections).
- Monitor process performance data; identify trends; recommend improvements for robustness, quality, and efficiency.
- Support tech transfer and process scale-up at CDMOs.
- Partner with Regulatory Affairs on CMC technical documentation for IND/BLA and agency responses.
- Author manufacturing technical reports.
- Support lifecycle management (process optimization, post-approval changes, CPV).
Education/Experience Requirements:
- Bachelor’s degree required (Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering or related). Advanced degree preferred.
- 8+ years relevant experience in biologics manufacturing, scale-up, and late-stage development/commercialization.
Additional Skills/Experience:
- Expertise in microbial fermentation and downstream processing for recombinant proteins/other biologics; PEGylation experience a plus.
- QbD experience; support PPQ/process validation.
- Experience preparing/supporting CMC manufacturing sections of BLAs.
- Knowledge of US/EU cGMP, FDA/ICH guidance, technology transfer, process validation, lifecycle management.
- CDMO oversight and technical issue resolution experience.
- Skills in statistical process monitoring, process characterization, quality risk management.
- Technical writing/documentation; strong communication, interpersonal, organizational skills.
- Travel 20–25% domestically/internationally; not 100% remote; onsite/face-to-face work in San Diego essential.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness/support programs; life insurance, disability; retirement with match; generous paid time off.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.
The Associate Director, Technical Operations, Biologics Drug Substance Manufacturing provides technical expertise and operational leadership/support for biologic drug substance manufacturing from late-stage clinical development through commercialization. Collaborates with Technical Operations, Quality, and Regulatory Affairs on manufacturing processes and validation activities at external CDMOs. Deep technical expertise in microbial fermentation (downstream) with experience supporting late-stage development, PPQ, and BLA submissions.
Responsibilities:
- Provide technical oversight for downstream drug substance manufacturing at CDMOs supporting late-stage clinical and commercial programs.
- Review/approve manufacturing documents (change notifications, batch records, process development, tech transfer, PC and PPQ protocols/reports).
- Serve as technical resource for GMP quality systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections).
- Monitor process performance data; identify trends; recommend improvements for robustness, quality, and efficiency.
- Support tech transfer and process scale-up at CDMOs.
- Partner with Regulatory Affairs on CMC technical documentation for IND/BLA and agency responses.
- Author manufacturing technical reports.
- Support lifecycle management (process optimization, post-approval changes, CPV).
Education/Experience Requirements:
- Bachelor’s degree required (Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering or related). Advanced degree preferred.
- 8+ years relevant experience in biologics manufacturing, scale-up, and late-stage development/commercialization.
Additional Skills/Experience:
- Expertise in microbial fermentation and downstream processing for recombinant proteins/other biologics; PEGylation experience a plus.
- QbD experience; support PPQ/process validation.
- Experience preparing/supporting CMC manufacturing sections of BLAs.
- Knowledge of US/EU cGMP, FDA/ICH guidance, technology transfer, process validation, lifecycle management.
- CDMO oversight and technical issue resolution experience.
- Skills in statistical process monitoring, process characterization, quality risk management.
- Technical writing/documentation; strong communication, interpersonal, organizational skills.
- Travel 20–25% domestically/internationally; not 100% remote; onsite/face-to-face work in San Diego essential.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness/support programs; life insurance, disability; retirement with match; generous paid time off.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.