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 must lead a highly efficient QC microbiology team, oversee gowning qualifications, and ensure timely completion of all sampling and testing activities.
BeOne offers a comprehensive benefits package including medical, dental, vision, 401(k), paid time off, and opportunities for discretionary 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: Eligible for annual bonus plan and discretionary equity awards; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, Wellness
Skills & Requirements
Must-have
FDA/EU regulatory compliance knowledge
Environmental monitoring program management
Utilities sampling for WFI and clean steam
OOS event investigation and CAPA implementation
GMP manufacturing support experience
Microbial method verification leadership
Nice-to-have
Advanced microbiology laboratory concepts
Strong analytical and problem-solving skills
Hands-on approach with can-do attitude
Proactive initiative in busy environments
Excellent project management capabilities
Key Requirements
Bachelor's degree in Microbiology or related field
Minimum 7 years in biological drug product QC
Minimum 5 years in management roles
Expertise in Data Integrity Guidance and systems
Familiarity with USP/EP and cGMP/EU GMP regulations