Strategic Lead, Commercial Drug Manufacturing

Travere Therapeutics

Des Moines (IA)

Hybrid

USD 150,000 - 195,000

Full time

7 days ago
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Benefits offered by this job

Premium health insurance
Stock options
retirement plan with employer match
Generous paid time off

Job summary

Travere Therapeutics is seeking an Associate Director of Commercial Manufacturing to lead strategy, governance, and execution of manufacturing for commercial products. You will coordinate with Supply Chain, Quality, Regulatory Affairs, and Commercial teams to translate forecasts into executable manufacturing plans and provide leadership with recommendations on capacity and external manufacturing strategy.

The role requires 8+ years in pharmaceutical manufacturing, a Bachelor’s in Process/

Qualifications

  • Bachelor's degree in Process or Chemical Engineering required; equivalent combination of education and applicable job experience may be considered.
  • 8+ years of progressive experience 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 S&OP 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 and troubleshooting.
  • Maintain up-to-date knowledge of US and EU GMPs and regulatory guidance for pharmaceutical manufacturing and packaging.
  • Represent commercial manufacturing for technical due diligence, CMO selection, and manufacturing-network strategy.
  • Assist with regulatory submissions (CMC sections) and during inspections and audits.

Skills

Process validation
Technology transfer
Project management
Regulatory knowledge
Cross-functional collaboration
Leadership

Education

Bachelor's degree in Process/ Chemical Engineering

Job description

Travere Therapeutics is seeking an Associate Director of Commercial Manufacturing to lead strategy, governance, and execution of manufacturing for commercial products. You will coordinate with Supply Chain, Quality, Regulatory Affairs, and Commercial teams to translate forecasts into executable manufacturing plans and provide leadership with recommendations on capacity and external manufacturing strategy.

The role requires 8+ years in pharmaceutical manufacturing, a Bachelor’s in Process/

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