Director, Biologics Operations

Travere Therapeutics; Washington (District of Columbia); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plans with employer match

Paid time off

Job summary

Travere Therapeutics in San Diego, CA, is seeking an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing, to lead technical operations oversight at CDMOs from late-stage development through commercialization.

The role focuses on downstream production, PPQ, BLA support, and collaboration with Quality and Regulatory Affairs, with travel up to 25% and on-site requirements in San Diego.

Qualifications

• Bachelor's degree required; advanced degrees preferred for seniority.
• 8+ years of biologics manufacturing, scale-up and late-stage development.
• Experience supporting regulatory submissions and process validation.

Responsibilities

• Provide technical oversight for biologics drug substance manufacturing at external CDMOs, focusing on downstream production.
• Review and approve manufacturing documentation including batch records and PPQ protocols.
• Support GMP systems, deviations, CAPAs and regulatory responses.
• Monitor process performance data and drive improvements for quality and efficiency.
• Lead tech transfer and process scale-up activities at CDMOs.
• Collaborate with Regulatory Affairs on CMC sections of IND/BLA filings.

Skills

Microbial fermentation

Downstream processing

Process development

CMC knowledge

QbD

Process validation

Statistical process control

Technical writing

Cross-functional collaboration

Travel readiness

Education

Bachelor's degree in Life Sciences or related

Advanced degree preferred (MS/PhD)

Tools

CDMO management

GMP knowledge

Process characterization

Job description

Travere Therapeutics in San Diego, CA, is seeking an Associate Director, Technical Operations, Biologics Drug Substance Manufacturing, to lead technical operations oversight at CDMOs from late-stage development through commercialization.

The role focuses on downstream production, PPQ, BLA support, and collaboration with Quality and Regulatory Affairs, with travel up to 25% and on-site requirements in San Diego.