Remote Biologics Operations Leader — Downstream & Tech Transfer

Travere Therapeutics; Kansas City (MO); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics, Inc. is seeking an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing to lead downstream operations from late-stage development through commercialization.

The role collaborates with Quality and Regulatory Affairs and external CDMOs to ensure robust biologics production. The ideal candidate has deep expertise in microbial fermentation, downstream processing, QbD, PPQ, and BLA support, with 8+ years in biologics manufacturing and experience with

Qualifications

• Bachelor's degree in life sciences, chemistry, or related discipline (advanced degree preferred).
• 8+ years of biologics manufacturing, scale-up, and late-stage development.
• Experience with PPQ, BLA submissions, and lifecycle management.

Responsibilities

• Provide technical oversight for biologics drug substance manufacturing at CDMOs, focusing on downstream production.
• Review and approve batch records, process development, tech transfer, PC, and PPQ reports.
• Support GMP quality systems including deviations, investigations, CAPAs, change controls, and regulatory submissions.
• Monitor process performance data, identify trends, and drive improvements.
• Assist tech transfer and scale-up at CDMOs.
• Collaborate with Regulatory Affairs on CMC sections of IND/BLA.
• Author technical reports on manufacturing topics.
• Support lifecycle management including CPV and post-approval changes.
• Additional duties as needed.

Skills

Biologics manufacturing

Downstream processing

Microbial fermentation

Late-stage development

Process Validation

BLA support

QbD

PPQ

CDMOs experience

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Job description

Travere Therapeutics, Inc. is seeking an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing to lead downstream operations from late-stage development through commercialization.

The role collaborates with Quality and Regulatory Affairs and external CDMOs to ensure robust biologics production. The ideal candidate has deep expertise in microbial fermentation, downstream processing, QbD, PPQ, and BLA support, with 8+ years in biologics manufacturing and experience with