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

beigene.se

hopewell, Nj, US
Base: $127,400.00 - $172,400.00 annually; bonus/eq...
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Qc microbiology environmental monitoring
Fda/eu regulations
Microbial contamination control
** BeOne Medicines is seeking a Senior Manager of QC Microbiology to oversee environmental monitoring and utilities sampling programs in compliance with FDA and EU regulations. The ideal candidate will have significant experience in biological drug product quality control and management, alongside a strong commitment to teamwork and excellence in fighting cancer. **

Job Summary

  • Manages all QC Microbiology Environmental Monitoring (EM) as well as the utilities sampling programs for WFI, Clean Steam, and Process Gases in accordance with FDA/EU regulations, applicable International Regulations, and BeOne processes and procedures.
  • Lead the Environmental Monitoring (EM) and Utilities Sampling programs in accordance with FDA/EU regulations and applicable International Regulations.
  • The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Matching Summary

Match Score: 75

** BeOne Medicines is seeking a Senior Manager of QC Microbiology to oversee environmental monitoring and utilities sampling programs in compliance with FDA and EU regulations. The ideal candidate will have significant experience in biological drug product quality control and management, alongside a strong commitment to teamwork and excellence in fighting cancer. **

Salary

Base: $127,400.00 - $172,400.00 annually; Bonus/Equity: Eligible for annual bonus plan, discretionary equity awards, Employee Stock Purchase Plan; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, Wellness

Skills & Requirements

Must-have

  • QC Microbiology Environmental Monitoring
  • FDA/EU regulations
  • Microbial contamination control
  • QC Trend Reports
  • QC Microbiology Deviations
  • GMP manufacturing

Nice-to-have

  • Scientific and business professionals
  • Collaborative and passionate interest
  • Keep the laboratory forward-looking
  • Hands-on approach
  • Can do attitude

Key Requirements

  • Bachelor’s Degree or above in Microbiology or Biotechnology
  • Minimum of 7 years' experience in biological drug product Quality Control
  • Minimum of 5 years' experience in management
  • Expert in environmental monitoring
  • Familiar with USP/EP and cGMP/EU GMP regulations

Work Rights

Not specified

Tailored Resume

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