Associate Director, Technical Operations, Biologics Drug Substance Manufacturing
Travere Therapeutics
August 30, 2026
On-site
San Diego Metropolitan Area
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), 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 biologics.
- Review/approve manufacturing documents (change notifications, batch records, process development, tech transfer, process characterization, PPQ protocols/reports).
- Serve as technical resource for GMP quality systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections).
- Monitor process performance trends and recommend improvements to boost robustness, quality, and efficiency.
- Support tech transfer and process scale-up.
- Partner with Regulatory Affairs on CMC technical documentation for IND, BLA, and responses.
- Author technical reports; support lifecycle management (optimization, post-approval changes, CPV).
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences/Chemistry/Pharm Sciences/Biochemistry/Chem Eng or related (M.S./Ph.D. preferred).
- 8+ years in biologics manufacturing, scale-up, and late-stage development/commercialization.
Additional Skills/Experience (Required/Preferred):
- Expertise in microbial fermentation and downstream processing for recombinant proteins/biologics (PEGylation a plus).
- QbD; experience with PPQ and process validation.
- Experience preparing/supporting CMC manufacturing sections of BLAs.
- Knowledge of US/EU cGMP, FDA/ICH, technology transfer, lifecycle management.
- CDMO oversight; statistical process monitoring/characterization and quality risk management.
- Travel 20–25%; not 100% remote; onsite/face-to-face function in San Diego.
Benefits/Compensation:
- Target base pay range: $150,000–$195,000; benefits include premium health, life insurance, disability, retirement match, generous PTO, wellness/support programs.
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), 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 biologics.
- Review/approve manufacturing documents (change notifications, batch records, process development, tech transfer, process characterization, PPQ protocols/reports).
- Serve as technical resource for GMP quality systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections).
- Monitor process performance trends and recommend improvements to boost robustness, quality, and efficiency.
- Support tech transfer and process scale-up.
- Partner with Regulatory Affairs on CMC technical documentation for IND, BLA, and responses.
- Author technical reports; support lifecycle management (optimization, post-approval changes, CPV).
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences/Chemistry/Pharm Sciences/Biochemistry/Chem Eng or related (M.S./Ph.D. preferred).
- 8+ years in biologics manufacturing, scale-up, and late-stage development/commercialization.
Additional Skills/Experience (Required/Preferred):
- Expertise in microbial fermentation and downstream processing for recombinant proteins/biologics (PEGylation a plus).
- QbD; experience with PPQ and process validation.
- Experience preparing/supporting CMC manufacturing sections of BLAs.
- Knowledge of US/EU cGMP, FDA/ICH, technology transfer, lifecycle management.
- CDMO oversight; statistical process monitoring/characterization and quality risk management.
- Travel 20–25%; not 100% remote; onsite/face-to-face function in San Diego.
Benefits/Compensation:
- Target base pay range: $150,000–$195,000; benefits include premium health, life insurance, disability, retirement match, generous PTO, wellness/support programs.
Application instructions:
- Apply on an ongoing basis until a candidate is selected.