Associate Director, Drug Substance Manufacturing (hopewell, Nj)

BeOne Medicines

Hopewell, NJ, US
Base: $139,200.00 - $189,200.00 annually; bonus/eq...
Large molecule manufacturing experience
Cell culture processing expertise
Single-use manufacturing processes
This site leadership position reports directly to the General Manager and requires robust demonstration of key leadership behaviors aligned with BeOne global competencies

Job Summary

  • This site leadership position reports directly to the General Manager and requires robust demonstration of key leadership behaviors aligned with BeOne global competencies.
  • The role focuses on leading technical implementation of cutting-edge large molecule manufacturing related to liquid aseptic filling and lyophilization while ensuring GMP readiness.
  • BeOne offers a comprehensive benefits package including Medical, Dental, Vision, 401(k), Life Insurance, Paid Time Off, and opportunities for discretionary equity awards.

Matching Summary

This site leadership position reports directly to the General Manager and requires robust demonstration of key leadership behaviors aligned with BeOne global competencies.

Salary

Base: $139,200.00 - $189,200.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Comprehensive package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, PTO

Skills & Requirements

Must-have

  • Large molecule manufacturing experience
  • Cell culture processing expertise
  • Single-use manufacturing processes
  • cGMP regulatory compliance knowledge
  • FDA/EMA inspection leadership
  • Equipment commissioning FAT/SAT
  • Quality system CAPA/DEV management

Nice-to-have

  • Lean Six Sigma background
  • Continuous improvement track record
  • Strong technical writing skills
  • Collaborative spirit and teamwork
  • Bold ingenuity in problem solving
  • Patient first mindset
  • Financial excellence awareness

Key Requirements

  • Bachelor's degree in Biotech, Biology, Chem Eng, Biochemistry or Life Sciences
  • Minimum 8 years experience in large molecule manufacturing
  • Minimum 6 years in a leadership role
  • Master's degree preferred
  • Deep understanding of cGMP environment
  • Proven experience with FDA/EMA regulations
  • Successful regulatory inspections (e.g., PAI)

Work Rights

Not specified

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