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

BeiGene

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 will lead the team in compiling trend reports, investigating OOS events, and implementing corrective actions to ensure data integrity.
  • BeOne offers a competitive salary range of $127,400.00 - $172,400.00 annually along with comprehensive benefits including medical, dental, vision, and 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), FSA/HSA, Life Insurance, 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
  • Microbial method verification

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 in cross-functional teams

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
  • Familiarity with USP/EP and cGMP/EU GMP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter