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

BeOne Medicines

Hopewell, NJ, US
Base: $127,400.00 - $172,400.00 annually; bonus/eq...
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Fda and eu regulatory compliance
Environmental monitoring program management
Utilities sampling for wfi and clean steam
** BeOne Medicines is seeking a Senior Manager for QC Microbiology to oversee environmental monitoring and utilities sampling programs while ensuring compliance with FDA/EU regulations. The ideal candidate will have extensive experience in quality control within a regulated biotech or pharmaceutical setting, 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 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 equity awards.

Matching Summary

Match Score: 75

** BeOne Medicines is seeking a Senior Manager for QC Microbiology to oversee environmental monitoring and utilities sampling programs while ensuring compliance with FDA/EU regulations. The ideal candidate will have extensive experience in quality control within a regulated biotech or pharmaceutical setting, along with strong leadership skills. **

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, PTO, Wellness

Skills & Requirements

Must-have

  • FDA and EU regulatory compliance
  • Environmental monitoring program management
  • Utilities sampling for WFI and clean steam
  • OOS event investigation and CAPA implementation
  • GMP manufacturing support
  • Microbial method verification

Nice-to-have

  • Advanced microbiology laboratory concepts
  • Strong leadership and team development skills
  • Data integrity guidance knowledge
  • LIMS and MODA system expertise
  • Proactive problem-solving attitude

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

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