Associate Director, Global Manufacturing & Packaging

Travere Therapeutics; Detroit (MI); Remote; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics is seeking an Associate Director, Commercial Manufacturing to lead manufacturing planning across its external network, ensuring reliable, compliant supply. You will partner with Supply Chain, Quality, Regulatory Affairs, Technical Operations and Commercial teams to translate forecasts into executable manufacturing plans.

The ideal candidate has 8+ years of experience in pharmaceutical manufacturing leadership, deep knowledge of process validation and technology transfer, and

Qualifications

• Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline.
• 8+ years of progressive experience leading 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 to ensure uninterrupted market supply.
• Establish and maintain manufacturing schedules based on internal sales forecasts and planned decisions; assess capacity, inventory, and supply risks and lead mitigation plans.
• Verify suitability, qualification and validation of processes at CMOs for drug product.
• Provide manufacturing support, troubleshooting, on internal and external project teams.
• Maintain 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.
• Additional duties assigned as needed.

Skills

Leadership

Project management

Communication

Education

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

Job description

Travere Therapeutics is seeking an Associate Director, Commercial Manufacturing to lead manufacturing planning across its external network, ensuring reliable, compliant supply. You will partner with Supply Chain, Quality, Regulatory Affairs, Technical Operations and Commercial teams to translate forecasts into executable manufacturing plans.

The ideal candidate has 8+ years of experience in pharmaceutical manufacturing leadership, deep knowledge of process validation and technology transfer, and