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

BeOne Medicines

Hopewell, NJ, US
Base: $127,400.00 - $172,400.00 annually; bonus/eq...
Fda/eu gmp regulations expertise
Environmental monitoring program leadership
Utilities sampling wfi clean steam gases
The role involves managing all QC Microbiology Environmental Monitoring and utilities sampling programs in strict accordance with FDA and EU regulations

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 team in investigating OOS events and implementing corrective actions to prevent recurrence of microbial data deviations.
  • BeOne Medicines offers a comprehensive benefits package including medical, dental, vision, 401(k), and opportunities for discretionary equity awards.

Matching Summary

The role involves managing all QC Microbiology Environmental Monitoring and utilities sampling programs in strict accordance with FDA and EU regulations.

Salary

Base: $127,400.00 - $172,400.00 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

  • FDA/EU GMP regulations expertise
  • Environmental monitoring program leadership
  • Utilities sampling WFI clean steam gases
  • OOS event investigation and CAPA management
  • Microbial method verification strategy
  • Team management and development skills

Nice-to-have

  • Data integrity guidance knowledge
  • LIMS and MODA system proficiency
  • Advanced microbiology concepts application
  • Collaborative spirit and initiative
  • Budget and efficiency target achievement

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 USP/EP and cGMP/EU GMP regulations
  • Experience with aseptic process contamination control

Work Rights

Not specified

Tailored Resume

Cover Letter