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

beonemedicines.us

Hopewell, NJ, US
Base: $127,400.00 - $172,400.00 annually; bonus/eq...
Fda/eu gmp regulatory compliance
Environmental monitoring program management
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 investigation of Out-of-Specification events and ensure appropriate corrective actions are implemented to prevent recurrence.
  • 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 regulatory compliance
  • Environmental monitoring program management
  • Utilities sampling WFI clean steam gases
  • OOS event investigation and CAPA implementation
  • Microbial method verification strategy
  • LIMS and MODA electronic systems

Nice-to-have

  • Advanced microbiology laboratory concepts
  • Strong leadership and team development skills
  • Proactive problem-solving in busy environments
  • Collaborative spirit and patient-first mindset

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
  • Expert knowledge of Data Integrity Guidance
  • Experience with USP/EP and cGMP/EU GMP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter