The role involves managing all QC Microbiology Environmental Monitoring and utilities sampling programs in accordance with FDA and EU regulations
Job Summary
The role involves managing all QC Microbiology Environmental Monitoring and utilities sampling programs in accordance with FDA and EU regulations.
Candidates must lead the team to ensure efficient day-to-day operations of the Microbiology laboratory while supporting GMP manufacturing.
BeOne offers a comprehensive benefits package including medical, dental, vision, 401(k), and opportunities for discretionary equity awards.
Matching Summary
The role involves managing all QC Microbiology Environmental Monitoring and utilities sampling programs in 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
Skills & Requirements
Must-have
FDA/EU regulations compliance
Environmental monitoring program management
Utilities sampling WFI Clean Steam
Microbial contamination control
OOS event investigation
CAPA implementation
GMP manufacturing support
Nice-to-have
Advanced microbiology concepts
Data Integrity Guidance knowledge
LIMS MODA systems expertise
Team development and mentoring
Budget and efficiency targets
Proactive problem solving attitude
Key Requirements
Bachelor's degree in Microbiology or Biotechnology
Minimum 7 years experience in biological drug product QC