Associate Director, Biologics Downstream Operations (Remote)

Travere Therapeutics; Columbus (OH); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Stock option / long-term incentives

Job summary

Travere Therapeutics is seeking an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing in a remote/hybrid setup. The role drives technical leadership for biologics manufacturing from late-stage development through commercialization.

You will partner across Technical Operations, Quality, and Regulatory to ensure robust, compliant processes and successful regulatory filings. The candidate will possess deep expertise in microbial fermentation and downstream processing,

Qualifications

• Bachelor's degree required in Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related discipline.
• Advanced degree (M.S. or Ph.D.) preferred.

Responsibilities

• Provide technical oversight for drug substance manufacturing activities at CDMOs, with focus on downstream production.
• Review and approve manufacturing documents including batch records, process development, tech transfer, PC and PPQ reports.
• Serve as technical resource for GMP quality systems, deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections.
• Monitor process performance, identify trends, and recommend improvements to increase robustness and quality.
• Support tech transfer and process scale-up at CDMOs.
• Collaborate with Regulatory Affairs to prepare CMC documentation for IND/BLA and regulatory responses.
• Author technical reports on manufacturing topics.
• Support lifecycle management including process optimization, post‑approval changes, and CPV.

Skills

Biologics manufacturing

Downstream processing

Technical writing

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related discipline

Advanced degree (M.S./Ph.D.) preferred

Job description

Travere Therapeutics is seeking an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing in a remote/hybrid setup. The role drives technical leadership for biologics manufacturing from late-stage development through commercialization.

You will partner across Technical Operations, Quality, and Regulatory to ensure robust, compliant processes and successful regulatory filings. The candidate will possess deep expertise in microbial fermentation and downstream processing,