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 regulatory compliance
Environmental monitoring programs
Utilities sampling wfi clean steam
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 to ensure efficient daily operations, oversee gowning qualifications, and manage microbial contamination control for aseptic processes.
  • BeOne Medicines offers a competitive salary range of $127,400 to $172,400 annually along with comprehensive benefits including equity awards and health insurance.

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 regulatory compliance
  • Environmental monitoring programs
  • Utilities sampling WFI Clean Steam
  • GMP manufacturing support
  • OOS event investigation
  • Microbial method verification

Nice-to-have

  • Strong leadership and team development
  • Data integrity guidance knowledge
  • LIMS and MODA system expertise
  • Advanced microbiology concepts
  • 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 management experience
  • Knowledge of Data Integrity Guidance
  • Experience with USP/EP and cGMP/EU GMP regulations

Work Rights

Not specified

Tailored Resume

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