Senior Director, Commercial Drug Manufacturing & Packaging

Travere Therapeutics; New York (NY); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health

Retirement plans

Paid time off

Job summary

Travere Therapeutics, based in San Diego with remote work options, is seeking an Associate Director of Commercial Manufacturing. You will lead external manufacturing networks, drive process validation and tech transfer, and ensure continuous supply of commercial products.

The role requires a Bachelor’s in a relevant field and 8+ years in pharmaceutical manufacturing, including multiple dosage forms. Travel up to 10% domestically and internationally is expected.

Qualifications

• Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline.
• 8+ years of progressive experience in pharmaceutical manufacturing and packaging shop floor activities.
• Manufacturing experience with multiple dosage forms, including oral solid dosage forms.

Responsibilities

• Direct and coordinate manufacturing activities at CMOs for commercial drug products.
• Establish and maintain manufacturing schedules based on internal sales forecasts and S&OP decisions.
• Verify suitability, qualification and validation of processes at CMOs for drug product.
• Provide manufacturing support, troubleshooting, on internal and external project teams.
• Maintains up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical drug product manufacturing and packaging.
• Represent commercial manufacturing for technical due diligence, CMO selection, qualification, contracting support, and manufacturing-network strategy.
• Author/edit technical reports on a variety of manufacturing-related subjects as needed.
• Assist management during regulatory inspections and internal, and external audits.
• Assist with the development of CMC sections of regulatory submissions.

Skills

Process validation

Technology transfer

Project management

Regulatory compliance

Education

Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline

Job description

Travere Therapeutics, based in San Diego with remote work options, is seeking an Associate Director of Commercial Manufacturing. You will lead external manufacturing networks, drive process validation and tech transfer, and ensure continuous supply of commercial products.

The role requires a Bachelor’s in a relevant field and 8+ years in pharmaceutical manufacturing, including multiple dosage forms. Travel up to 10% domestically and internationally is expected.