BeiGene is seeking a Senior Manager of QC Microbiology in Hopewell, NJ, to oversee environmental monitoring and utilities sampling programs in compliance with FDA/EU regulations. The ideal candidate should have extensive experience in quality control within the biotechnology or pharmaceutical sector, along with strong leadership skills
Job Summary
Manages all QC Microbiology Environmental Monitoring (EM) as well as the utilities sampling programs for WFI, Clean Steam, and Process Gases in accordance with FDA/EU regulations, applicable International Regulations, and BeOne processes and procedures.
Build a highly efficient QC microbiology team, identify and develop key talents.
Ensure that the QC Micro-Lab meets or improves on budget, cost, volume and efficiency targets (KPIs) in line with business objectives.
Matching Summary
Match Score: 85
BeiGene is seeking a Senior Manager of QC Microbiology in Hopewell, NJ, to oversee environmental monitoring and utilities sampling programs in compliance with FDA/EU regulations. The ideal candidate should have extensive experience in quality control within the biotechnology or pharmaceutical sector, along with strong leadership skills.
Salary
Base: $127,400.00 - $172,400.00 annually; Bonus/Equity: Eligible for annual bonus plan; Benefits: Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness
Skills & Requirements
Must-have
Manage QC Microbiology Environmental Monitoring
Oversee utilities sampling programs
Author and review QC Trend Reports
Support regulatory compliance inspections
Lead QC Microbiology laboratory activities
Ensure Micro-Lab EHS compliance
Nice-to-have
Introduce advanced concepts
Keep laboratory forward-looking
Highly motivated, collaborative professionals
Key Requirements
Bachelor’s Degree or above in Microbiology or Biotechnology
Minimum of 7 years’ experience in biological drug product Quality Control