Biologics Downstream Ops Lead — Tech Transfer & CDMO
Travere Therapeutics
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Benefits offered by this job
Job summary
Travere Therapeutics in San Diego, with remote work options, is seeking an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing. You will provide technical leadership for biologics manufacturing at external CDMOs, focusing on downstream production, and collaborate across Quality, Regulatory, and Technical Operations to enable late-stage development through commercialization.
The role requires deep expertise in microbial fermentation, PPQ, and BLA support, plus
Qualifications
- Bachelor's degree in Life Sciences or related discipline required; advanced degree preferred.
- 8+ years of biologics manufacturing, scale-up, and late-stage development experience.
Responsibilities
- Provide technical oversight for drug substance manufacturing at CDMOs with focus on downstream production.
- Review/approve manufacturing docs including change notifications, batch records, tech transfer, PC and PPQ reports.
- Support GMP quality systems: deviations, investigations, CAPAs, change controls, regulatory submissions, inspections.
- Monitor process data, identify trends, and recommend improvements for robustness and efficiency.
- Lead tech transfer and process scale-up at CDMOs; partner with Regulatory Affairs for CMC sections of IND/BLA.
Skills
Education
Job description
Travere Therapeutics in San Diego, with remote work options, is seeking an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing. You will provide technical leadership for biologics manufacturing at external CDMOs, focusing on downstream production, and collaborate across Quality, Regulatory, and Technical Operations to enable late-stage development through commercialization.
The role requires deep expertise in microbial fermentation, PPQ, and BLA support, plus
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