Job Title: Senior Manager Qc Microbiology, (hopewell, Nj)

BeOne Medicines

Hopewell, NJ, US
Base: $127,400.00 - $172,400.00 annually; bonus/eq...
Not specified (assumed onsite based on job nature).
Fda and eu gmp regulations knowledge
Environmental monitoring program management
Utilities sampling for wfi and clean steam
BeOne Medicines is seeking a Senior Manager for QC Microbiology in Hopewell, NJ, to lead Environmental Monitoring and utilities sampling programs in compliance with FDA/EU regulations. The ideal candidate will have extensive experience in quality control within a regulated biotechnology or pharmaceutical environment, along with strong leadership skills

Job Summary

  • The role involves managing all QC Microbiology Environmental Monitoring and utilities sampling programs in strict accordance with FDA and EU regulations.
  • Candidates must lead the development of a highly efficient QC microbiology team while overseeing gowning and aseptic qualifications for site-wide personnel.
  • BeOne Medicines offers a competitive salary range, annual bonus eligibility, equity awards, and a comprehensive benefits package including medical and dental coverage.

Matching Summary

Match Score: 85

BeOne Medicines is seeking a Senior Manager for QC Microbiology in Hopewell, NJ, to lead Environmental Monitoring and utilities sampling programs in compliance with FDA/EU regulations. The ideal candidate will have extensive experience in quality control within a regulated biotechnology or pharmaceutical environment, along with strong leadership skills.

Salary

Base: $127,400.00 - $172,400.00 annually; Bonus/Equity: Annual bonus plan eligible; Equity: Discretionary stock awards and Employee Stock Purchase Plan available; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, PTO

Skills & Requirements

Must-have

  • FDA and EU GMP regulations knowledge
  • Environmental monitoring program management
  • Utilities sampling for WFI and clean steam
  • Microbial contamination control expertise
  • OOS event investigation and CAPA implementation
  • LIMS and MODA electronic system proficiency

Nice-to-have

  • Strong leadership and team mentoring skills
  • Advanced microbiology laboratory concepts
  • Excellent project management abilities
  • Hands-on approach with can-do attitude
  • Proactive initiative in busy environments

Key Requirements

  • Bachelor's degree in Microbiology or related field
  • Minimum 7 years experience in biological drug product QC
  • Minimum 5 years experience in management roles
  • Expertise in Data Integrity Guidance and systems
  • Knowledge of USP/EP and cGMP/EU GMP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter