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 the development of a highly efficient QC microbiology team while overseeing gowning qualifications and aseptic process contamination control.
BeOne Medicines offers a competitive salary range, annual bonus eligibility, 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 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, and Wellness
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
Strong leadership and team development skills
Experience with LIMS and MODA systems
Proactive problem-solving attitude
Forward-looking laboratory concepts
Collaborative spirit across global 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