Associate Director, Biologics Drug Substance Ops

Travere Therapeutics; Manchester (NH); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Well-being programs

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics in San Diego, CA, seeks an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing. Lead tech oversight for biologics substance manufacturing from late‑stage development to commercialization, coordinating with CDMOs and internal teams on downstream production and PPQ activities.

The ideal candidate has deep microbial fermentation expertise, PPQ/BLA experience, and strong knowledge of cGMPs.

Qualifications

• Bachelor's degree in Life Sciences or related field required; advanced degree preferred.
• 8+ years of biologics manufacturing, scale‑up, late stage development and commercialization.
• Deep expertise in microbial fermentation with downstream focus and PPQ/BLA experience.

Responsibilities

• Provide technical oversight for biologics drug substance manufacturing at CDMOs, focusing on downstream production.
• Review and approve batch records, change controls, tech transfers and PPQ reports.
• Support regulatory submissions and lifecycle management, including CPV and post‑approval changes.
• Collaborate with Quality, Regulatory Affairs, and CDMOs to ensure GMP compliance.
• Monitor process performance and drive improvements for robustness and efficiency.
• Author technical reports and support CMC sections of IND/BLA and agency responses.
• Travel 20–25% domestically and internationally as needed.
• Maintain strong written documentation and cross‑functional communication.

Skills

Microbial fermentation

Downstream processing

Process validation

Regulatory submissions

Technical leadership

Education

Bachelor's degree in Life Sciences or related

Advanced degree preferred (MS/PhD)

Job description

Travere Therapeutics in San Diego, CA, seeks an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing. Lead tech oversight for biologics substance manufacturing from late‑stage development to commercialization, coordinating with CDMOs and internal teams on downstream production and PPQ activities.

The ideal candidate has deep microbial fermentation expertise, PPQ/BLA experience, and strong knowledge of cGMPs.