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

BeOne

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 investigating OOS events and implementing corrective actions to prevent recurrence of microbial data deviations.
  • BeOne offers a comprehensive benefits package including medical, dental, vision, 401(k), and opportunities for 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: Annual bonus plan eligible; Equity: Discretionary stock awards available; Benefits: Medical, Dental, Vision, 401(k), PTO

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

Nice-to-have

  • Advanced microbiology laboratory concepts
  • Strong leadership and team development skills
  • Experience with LIMS and MODA systems
  • 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
  • Knowledge of Data Integrity Guidance and USP/EP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter