Associate Director, Drug Substance Manufacturing (hopewell, Nj)

BeOne Medicines

Hopewell, New Jersey, United States
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
This site leadership position at Hopewell, NJ reports directly to the General Manager and leads a team focused on fighting cancer through innovative drug substance manufacturing

Job Summary

  • This site leadership position at Hopewell, NJ reports directly to the General Manager and leads a team focused on fighting cancer through innovative drug substance manufacturing.
  • The role requires leading technical implementation of cutting-edge large molecule manufacturing including liquid aseptic filling and lyophilization while ensuring strict adherence to cGMP compliance.
  • Candidates will benefit from a comprehensive benefits package including medical, dental, vision, 401(k), and opportunities for discretionary equity awards and annual bonuses.

Matching Summary

This site leadership position at Hopewell, NJ reports directly to the General Manager and leads a team focused on fighting cancer through innovative drug substance manufacturing.

Salary

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

Skills & Requirements

Must-have

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

Nice-to-have

  • Lean Six Sigma operational excellence background
  • Master's or PhD degree preferred
  • Strong technical writing skills
  • Patient First collaborative spirit values
  • Bold Ingenuity driving excellence mindset

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 success with pre-approval inspections (PAI)

Work Rights

Not specified

Tailored Resume

Cover Letter