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

BeOne Medicines

Hopewell, NJ, US
Base: $127,400.00 - $172,400.00 annually; bonus/eq...
Fda and eu regulatory compliance
Environmental monitoring program management
Utilities sampling for wfi and 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 in compiling trend reports, investigating OOS events, and implementing corrective actions to prevent recurrence.
  • BeOne Medicines offers a comprehensive benefits package including medical, dental, vision, 401(k), and opportunities for equity ownership.

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

Nice-to-have

  • Advanced microbiology laboratory concepts
  • Strong leadership and team development skills
  • Experience with LIMS and MODA systems
  • Proactive problem-solving attitude
  • Collaborative spirit across global teams

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter