Associate Director, Commercial Mfg & Packaging - Remote

Travere Therapeutics; Columbus (OH); Remote; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego, USA - Remote is seeking an Associate Director, Commercial Manufacturing to lead strategy, oversight, and execution of external manufacturing networks for commercial drug products. This role builds manufacturing plans and oversees technology transfer and risk management across the network.

The role partners with Supply Chain, Quality, Regulatory Affairs, Technical Operations, and Commercial teams to translate forecasts into executable plans and provide senior

Qualifications

• Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline.
• 8+ years of progressive experience directly leading pharmaceutical manufacturing and packaging shop floor activities.
• 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.

Education

Bachelor's degree in Process/Chemical Engineering or Life Sciences

Job description

Travere Therapeutics in San Diego, USA - Remote is seeking an Associate Director, Commercial Manufacturing to lead strategy, oversight, and execution of external manufacturing networks for commercial drug products. This role builds manufacturing plans and oversees technology transfer and risk management across the network.

The role partners with Supply Chain, Quality, Regulatory Affairs, Technical Operations, and Commercial teams to translate forecasts into executable plans and provide senior