Remote Associate Director, Biologics Manufacturing Ops

Travere Therapeutics

Wichita (KS)

On-site

USD 150,000 - 195,000

Full time

14 days+

Application generator

Turn this role into an interview — a resume and cover letter built around what this employer wants.

Get past ATS filters

Benefits offered by this job

Health insurance

Retirement match

Stock incentives

Paid time off

Job summary

Travere Therapeutics in San Diego, with remote options, is seeking an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing. You will provide technical leadership for biologic drug substance manufacturing at CDMOs from late-stage development through commercialization, focusing on downstream production and PPQ processes.

The role requires deep expertise in microbial fermentation and downstream processing of biologics, CMC documentation, and collaboration across

Qualifications

Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related discipline.
8+ years of biologics manufacturing, scale‑up, and late stage development and commercialization.

Responsibilities

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