Associate Director, External Manufacturing

leHACK

Fully remote
7 years relevant work experience in manufacturing
5 years experience in drug substance
Leading new product introduction and technical transfers
leHACK is seeking an Associate Director of External Manufacturing to lead technical operations for drug substance manufacturing within its External Manufacturing Network. The role requires strong leadership, technical expertise, and effective collaboration with external partners to ensure successful manufacturing processes

Job Summary

  • This role involves leading technical operations within the External Manufacturing Network to support commercialization and manufacture of drug substance.
  • The successful candidate will act as the primary interface between technical operations and external partners while executing technical due diligence assessments.
  • The position requires driving continuous process verification and managing complex investigations with appropriate interfaces across multiple manufacturing sites.

Matching Summary

Match Score: 85

leHACK is seeking an Associate Director of External Manufacturing to lead technical operations for drug substance manufacturing within its External Manufacturing Network. The role requires strong leadership, technical expertise, and effective collaboration with external partners to ensure successful manufacturing processes.

Skills & Requirements

Must-have

  • 7 years relevant work experience in manufacturing
  • 5 years experience in drug substance
  • Leading new product introduction and technical transfers
  • Process development and scale up expertise
  • Root cause analysis and risk assessment skills
  • Strong knowledge of quality systems and validation

Nice-to-have

  • Knowledge of flow chemistry and enzyme manufacture
  • Lean Manufacturing or Six Sigma experience
  • Project management experience
  • Experience supporting regulatory inspections
  • Inclusive people leadership capabilities

Key Requirements

  • Bachelor's degree in engineering or chemistry sciences
  • Minimum 7 years of relevant manufacturing experience
  • Minimum 5 years of drug substance experience
  • Ability to travel approximately 25%

Work Rights

Not specified

Tailored Resume

Cover Letter