Biologics Downstream Ops Director (Remote)

Travere Therapeutics; Denver (CO); On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics is seeking an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing, to lead technical oversight for biologic drug substance manufacturing with external CDMOs through late-stage development to commercialization.

The ideal candidate will have deep microbial fermentation expertise, strong GMP/QA experience, and a track record in PPQ, BLA support, and process validation.

Qualifications

• Bachelor's degree in Life Sciences or related discipline required; advanced degree preferred.
• 8+ years of biologics manufacturing, scale-up, late-stage development and commercialization.

Responsibilities

• Provide technical oversight for drug substance manufacturing at CDMOs, focusing on downstream production.
• Review and approve manufacturing documents including batch records, change notices and PPQ reports.
• Serve as technical resource for GMP quality systems, deviations, investigations, CAPAs and regulatory submissions.
• Monitor process performance data; identify trends and implement improvements to increase robustness and efficiency.
• Support tech transfer and process scale‑up at CDMOs; collaborate with Regulatory Affairs for CMC sections of IND/BLA.
• Author technical reports and support lifecycle management, including CPV and post‑approval changes.

Skills

Technical leadership

Process validation

GMP knowledge

Cross-functional collaboration

Regulatory documentation

Education

Bachelor's degree in Life Sciences or related

Advanced degree preferred (MS/PhD)

Tools

CDMO management

Process monitoring tools

Job description

Travere Therapeutics is seeking an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing, to lead technical oversight for biologic drug substance manufacturing with external CDMOs through late-stage development to commercialization.

The ideal candidate will have deep microbial fermentation expertise, strong GMP/QA experience, and a track record in PPQ, BLA support, and process validation.