Associate Director, Biologics Manufacturing & Tech Transfer
Travere Therapeutics
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Benefits offered by this job
Job summary
Travere Therapeutics is seeking an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing to lead technical operations for biologics from late-stage development through commercialization. The role focuses on downstream processing, working with CDMOs, and ensuring QbD/PPQ alignment while supporting regulatory submissions.
The candidate will review manufacturing documentation, drive process improvements, and partner with Regulatory Affairs on IND/BLA materials.
Qualifications
- Bachelor's degree in Life Sciences or related discipline required.
- 8+ years of biologics manufacturing, scale-up, and late-stage development experience.
Responsibilities
- Provide technical oversight for drug substance manufacturing at CDMOs, focused on downstream production.
- Review and approve batch records, process development, tech transfer, PC and PPQ reports.
- Support GMP quality systems incl deviations, investigations, CAPAs, change controls, and regulatory submissions.
- Collaborate with Regulatory Affairs to prepare CMC documentation for IND/BLA and regulatory responses.
- Author technical reports and support lifecycle management activities.
Skills
Education
Job description
Travere Therapeutics is seeking an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing to lead technical operations for biologics from late-stage development through commercialization. The role focuses on downstream processing, working with CDMOs, and ensuring QbD/PPQ alignment while supporting regulatory submissions.
The candidate will review manufacturing documentation, drive process improvements, and partner with Regulatory Affairs on IND/BLA materials.
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