Strategic Lead, Commercial Manufacturing & Packaging

Travere Therapeutics; Wichita (KS); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego, CA, seeks an Associate Director, Commercial Manufacturing to lead manufacturing planning, CMO governance, process validation, and tech transfer across Travere's external network. This role ensures uninterrupted supply of commercial drug products and strategic external manufacturing decisions.

You will collaborate with Supply Chain, Quality, Regulatory Affairs, Technical Operations and Commercial teams to translate forecasts into executable plans, manage risk,

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 including process troubleshooting and optimization.
• 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.

Education

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

Job description

Travere Therapeutics in San Diego, CA, seeks an Associate Director, Commercial Manufacturing to lead manufacturing planning, CMO governance, process validation, and tech transfer across Travere's external network. This role ensures uninterrupted supply of commercial drug products and strategic external manufacturing decisions.

You will collaborate with Supply Chain, Quality, Regulatory Affairs, Technical Operations and Commercial teams to translate forecasts into executable plans, manage risk,