Associate Director, Drug Substance Manufacturing (hopewell, Nj)

BeOne Medicines Ltd

Hopewell, NJ, US
Base: $139,200.00 - $189,200.00 annually; bonus/eq...
8+ years large molecule manufacturing experience
6+ years leadership role in gmp environment
Cell culture processing expertise required
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 strict adherence to compliance requirements.
  • 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

  • 8+ years large molecule manufacturing experience
  • 6+ years leadership role in GMP environment
  • Cell culture processing expertise required
  • Single-use manufacturing process knowledge
  • FDA/EMA regulatory inspection experience
  • Equipment FAT/SAT/IOQ commissioning skills
  • CQV commissioning and GMP readiness

Nice-to-have

  • Lean Six Sigma operational excellence background
  • Master's or PhD degree preferred
  • Strong technical writing and communication skills
  • Experience with liquid aseptic filling and lyophilization
  • Demonstrated behavioral competencies alignment
  • SAP, SCADA, and DCS system familiarity

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
  • Deep understanding of cGMP, FDA/EMA regulations
  • Proven experience with successful regulatory inspections

Work Rights

Not specified

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