Strategic Leader, Commercial Drug Manufacturing & Packaging

Travere Therapeutics; Providence (RI); On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics seeks an Associate Director of Commercial Manufacturing to lead strategy, oversight, and execution of drug product manufacturing and packaging across external CMOs. You will align on forecasts, capacity, and risk with stakeholders to ensure reliable supply.

The role requires a Bachelor’s in Engineering or Life Sciences and 8+ years of pharmaceutical manufacturing leadership, with experience in multiple dosage forms and technology transfer.

Qualifications

• Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline required. Equivalent combination of education and applicable job experience may be considered.
• 8+ years of progressive experience directly leading pharmaceutical manufacturing and packaging shop floor activities including process troubleshooting and optimization activities required.
• Manufacturing experience with multiple dosage forms desired, 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 Sales & Operations Planning meeting decisions; assess capacity, inventory, and supply risks and lead the development of mitigation and contingency plans.
• Verify suitability, qualification and validation of processes at Contract Manufacturing Organizations (CMO) 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.
• Additional duties assigned as needed.

Skills

Process validation

Technology transfer

Project management

Education

Bachelor’s degree in Process or Chemical Engineering, Life Sciences

Job description

Travere Therapeutics seeks an Associate Director of Commercial Manufacturing to lead strategy, oversight, and execution of drug product manufacturing and packaging across external CMOs. You will align on forecasts, capacity, and risk with stakeholders to ensure reliable supply.

The role requires a Bachelor’s in Engineering or Life Sciences and 8+ years of pharmaceutical manufacturing leadership, with experience in multiple dosage forms and technology transfer.