Associate Director, Commercial Drug Manufacturing

Travere Therapeutics; Columbia (SC); On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics is seeking an Associate Director, Commercial Manufacturing to lead strategy, oversight, and execution of external drug product manufacturing. You will align manufacturing plans with forecasts, manage CMO performance, and ensure compliant, uninterrupted supply of products.

You will partner with Supply Chain, Quality, Regulatory Affairs, Technical Operations, and Commercial teams to translate forecasts into executable plans and guide capacity decisions.

Qualifications

• Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline required.
• 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 S&OP decisions; assess capacity, inventory, and supply risks and lead mitigation.
• Verify suitability, qualification and validation of processes at CMOs for drug product.
• Provide manufacturing support and troubleshooting on internal and external project teams.
• Maintain up-to-date knowledge of US and EU GMPs and regulatory guidance applicable to pharma manufacturing.
• Represent commercial manufacturing for technical due diligence, CMO selection, contracting support, and manufacturing-network strategy.
• Assist with development of CMC sections of regulatory submissions.
• Assist with regulatory inspections and audits.

Skills

Process validation

Technology transfer

Manufacturing leadership

Regulatory compliance

Project management

Education

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

Job description

Travere Therapeutics is seeking an Associate Director, Commercial Manufacturing to lead strategy, oversight, and execution of external drug product manufacturing. You will align manufacturing plans with forecasts, manage CMO performance, and ensure compliant, uninterrupted supply of products.

You will partner with Supply Chain, Quality, Regulatory Affairs, Technical Operations, and Commercial teams to translate forecasts into executable plans and guide capacity decisions.