Associate Director, Technical Operations, Biologics Drug Substance Manufacturing
Travere Therapeutics
August 08, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Operations
Position Summary:
Associate Director, Technical Operations, Biologics Drug Substance Manufacturing. Provide technical expertise and operational leadership for biologic drug substance manufacturing from late-stage clinical development through commercialization. Collaborate with Technical Operations, Quality, and Regulatory Affairs on manufacturing processes and validation at external CDMOs. Deep expertise in microbial fermentation (downstream production); experience supporting late-stage development, PPQ, and BLA submissions.
Responsibilities:
- Provide technical oversight for downstream drug substance manufacturing at CDMOs supporting late-stage clinical/commercial biologics.
- Review/approve manufacturing documents: change notifications, batch records, process development, tech transfer, process characterization (PC), 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.
- Partner with Regulatory Affairs for CMC documentation for IND, BLA, and regulatory responses.
- Author technical manufacturing reports; support lifecycle management (process optimization, post-approval changes, CPV).
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences/Chemistry/Pharma/Biochemistry/Chemical Engineering or related; advanced degree (M.S./Ph.D.) preferred.
- 8+ years relevant experience in biologics manufacturing, scale-up, and late-stage development/commercialization.
Additional Skills/Experience (Required/Preferred):
- Strong microbial fermentation and downstream processing expertise; PEGylation experience preferred.
- QbD experience; support PPQ/process validation.
- Experience preparing/supporting BLA CMC manufacturing sections.
- Knowledge of US/EU cGMP, FDA/ICH guidance, tech transfer, process validation, lifecycle management.
- CDMO oversight experience; statistical process monitoring, process characterization, quality risk management.
- Technical writing; strong communication/organization; travel 20%-25%.
Benefits:
- Premium health and other benefits, life insurance/disability/retirement match, generous paid time off.
Compensation:
- Target base pay range: $150,000.00–$195,000.00.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.
Associate Director, Technical Operations, Biologics Drug Substance Manufacturing. Provide technical expertise and operational leadership for biologic drug substance manufacturing from late-stage clinical development through commercialization. Collaborate with Technical Operations, Quality, and Regulatory Affairs on manufacturing processes and validation at external CDMOs. Deep expertise in microbial fermentation (downstream production); experience supporting late-stage development, PPQ, and BLA submissions.
Responsibilities:
- Provide technical oversight for downstream drug substance manufacturing at CDMOs supporting late-stage clinical/commercial biologics.
- Review/approve manufacturing documents: change notifications, batch records, process development, tech transfer, process characterization (PC), 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.
- Partner with Regulatory Affairs for CMC documentation for IND, BLA, and regulatory responses.
- Author technical manufacturing reports; support lifecycle management (process optimization, post-approval changes, CPV).
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences/Chemistry/Pharma/Biochemistry/Chemical Engineering or related; advanced degree (M.S./Ph.D.) preferred.
- 8+ years relevant experience in biologics manufacturing, scale-up, and late-stage development/commercialization.
Additional Skills/Experience (Required/Preferred):
- Strong microbial fermentation and downstream processing expertise; PEGylation experience preferred.
- QbD experience; support PPQ/process validation.
- Experience preparing/supporting BLA CMC manufacturing sections.
- Knowledge of US/EU cGMP, FDA/ICH guidance, tech transfer, process validation, lifecycle management.
- CDMO oversight experience; statistical process monitoring, process characterization, quality risk management.
- Technical writing; strong communication/organization; travel 20%-25%.
Benefits:
- Premium health and other benefits, life insurance/disability/retirement match, generous paid time off.
Compensation:
- Target base pay range: $150,000.00–$195,000.00.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.