Associate Director, Commercial Drug Manufacturing & Packaging

Travere Therapeutics; United States; On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics is a San Diego-based biopharmaceutical company seeking an Associate Director, Commercial Manufacturing. The role leads external manufacturing planning, CMO governance, technology transfer, and validation to ensure an uninterrupted supply of commercial products.

The candidate will collaborate with Supply Chain, Quality, Regulatory Affairs, and other stakeholders to translate forecasts into executable manufacturing plans, advise on capacity and risk, and support regulatory

Qualifications

• Bachelor’s degree in Process or Chemical Engineering, Life Sciences, or related discipline.
• 8+ years leading pharmaceutical manufacturing and packaging shop floor activities.
• Experience with multiple dosage forms, including oral solids.

Responsibilities

• Direct and coordinate manufacturing activities at CMOs for commercial drug products.
• Establish and maintain manufacturing schedules based on forecasts and S&OP decisions; assess capacity and risks.
• Verify suitability, qualification and validation of processes at CMOs for drug product.
• Provide manufacturing support and troubleshooting on internal and external projects.
• Maintain knowledge of US and EU GMPs and regulatory guidance relevant to manufacturing and packaging.
• Represent commercial manufacturing for due diligence, CMO selection, contracting support, and network strategy.
• Draft/edit technical reports on manufacturing-related subjects as needed.
• Assist management during regulatory inspections and audits.
• Assist with development of CMC sections of regulatory submissions.
• Additional duties as needed.

Skills

Process validation

Technology transfer

Project management

Cross-functional collaboration

Regulatory knowledge (GMPs)

Education

Bachelor's in Process/Chemical Engineering or Life Sciences

Job description

Travere Therapeutics is a San Diego-based biopharmaceutical company seeking an Associate Director, Commercial Manufacturing. The role leads external manufacturing planning, CMO governance, technology transfer, and validation to ensure an uninterrupted supply of commercial products.

The candidate will collaborate with Supply Chain, Quality, Regulatory Affairs, and other stakeholders to translate forecasts into executable manufacturing plans, advise on capacity and risk, and support regulatory