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 a highly efficient team, oversee gowning qualifications, and ensure timely completion of microbial testing to support GMP manufacturing.
BeOne offers a competitive salary range, annual bonus eligibility, discretionary equity awards, and a comprehensive benefits package including medical and dental coverage.
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 awards and ESPP available; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, PTO
Skills & Requirements
Must-have
FDA/EU regulatory compliance expertise
Environmental monitoring program leadership
Utilities sampling for WFI and clean steam
GMP manufacturing support experience
OOS event investigation and CAPA management
Nice-to-have
Advanced microbiology laboratory concepts
Strong team coaching and mentoring skills
Proactive problem-solving attitude
Experience with LIMS and MODA systems
Key Requirements
Bachelor's degree in Microbiology or related field