Director, Drug Product Manufacturing (hopewell, Nj)

BeOne Medicines Ltd.

Hopewell, New Jersey, United States
Base: $167,100.00 - $227,100.00 annually; bonus/eq...
10 years large molecule manufacturing experience
7 years leadership role in gmp environment
Aseptic filling and lyophilization 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 product 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 product manufacturing.
  • The role requires leading process optimizations, executing tech-transfers, and managing global health authority inspections while ensuring strict adherence to cGMP compliance.
  • Candidates must demonstrate deep understanding of large molecule manufacturing processes including liquid aseptic filling and lyophilization with a proven track record in quality systems.

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 product manufacturing.

Salary

Base: $167,100.00 - $227,100.00 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

  • 10 years large molecule manufacturing experience
  • 7 years leadership role in GMP environment
  • Aseptic filling and lyophilization expertise
  • FDA/EMA regulatory inspection experience
  • Equipment FAT/SAT/IOQ commissioning skills
  • CQV commissioning and GMP readiness
  • Lean Six Sigma operational excellence

Nice-to-have

  • Patient First collaborative spirit values
  • Bold Ingenuity and Driving Excellence
  • Master's degree or PhD preferred
  • Strong technical writing communication skills
  • SAP SCADA DCS computer system familiarity
  • Global health authority inspection success

Key Requirements

  • Bachelor's degree in Biotech, Biology, Chem Eng, Biochemistry or Life Sciences
  • Minimum 10 years experience in large molecule drug product processes
  • Minimum 7 years in a leadership role
  • Deep understanding of cGMP, FDA/EMA regulations and successful PAI inspections
  • Proven experience with CAPA, deviations, and change controls

Work Rights

Not specified

Tailored Resume

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