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 to ensure strict adherence to FDA and EU regulations

Job Summary

  • The role involves managing all QC Microbiology Environmental Monitoring and utilities sampling programs to ensure strict adherence to FDA and EU regulations.
  • Candidates will lead a highly efficient team, oversee gowning qualifications, and drive continuous improvement in laboratory operations and data integrity.
  • BeOne 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 to ensure strict adherence to 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
  • OOS event investigation and CAPA implementation
  • GMP manufacturing support
  • Microbial method verification

Nice-to-have

  • Advanced microbiology laboratory concepts
  • LIMS and MODA electronic systems knowledge
  • Strong leadership and team development skills
  • Proactive problem-solving attitude
  • Experience with aseptic process contamination control

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
  • Expertise in Data Integrity Guidance and management systems
  • Knowledge of USP/EP and cGMP/EU GMP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter