Lead Microbiologist

Description

• Communicate effectively with other shifts and departments regarding special testing requirements and relevant issues.
• Ensure adherence to cGMP, USP, and internal SOPs across all microbiology activities.
• Support internal and external audits by providing documentation and subject matter expertise.
• Collect and analyze environmental monitoring samples, including USP Purified Water, soft water, air, and equipment surfaces.
• Assign daily tasks, monitor progress, and ensure timely completion of testing and documentation.
• Handle live microbiological agents and cultures, performing growth promotion testing as per USP and SOP requirements.
• Evaluate data for trends and contribute to the development and revision of SOPs and microbiological test methods.
• Participate in Out-of-Specification (OOS) investigations, deviations, and Corrective and Preventive Actions (CAPAs).
• Oversee aseptic microbiological testing of raw materials, in-process materials, and finished products using USP agar methods.
• Serve as the primary point of contact for technical questions and troubleshooting within the microbiology team.
• Assist with inventory management and ensure adequate lab supplies are maintained.
• Review and approve laboratory data for accuracy, completeness, and compliance with regulatory standards.
• Calibrate, operate, and maintain laboratory instrumentation used in product testing.
• Foster a culture of safety, compliance, and continuous improvement in laboratory operations.
• Supervise and mentor a team of four microbiology technicians, providing training, guidance, and performance feedback.
• Complete administrative documentation and support lab investigations as needed.
• Drive process improvements to enhance efficiency, accuracy, and compliance within the microbiology lab.

Requirements

• Ability to read, interpret, and follow technical data and SOPs.
• Strong understanding of scientific principles and logical problem-solving.
• Proficiency in relevant computer software and laboratory systems.
• Additional certifications in Quality Control or Microbiology techniques are a plus.
• Excellent math and reasoning skills; detail-oriented and highly organized.
• Familiarity with various microbiological testing apparatus.
• Advanced degree (Master’s) in Microbiology or related field preferred.
• Bachelor of Science in Microbiology, Biology, Biochemistry, or related field.
• Effective verbal and written communication skills.
• Self-motivated with the ability to work independently.

Benefits

• Employee Assistance Program
• Critical Illness, Accident, and Hospital
• Health Spending Account (HSA)
• Short and long-term disability
• Transportation benefits
• Medical, dental & vision
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Time Off/Leave (PTO, Vacation or Sick Leave)
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)

Training + Development

Interview process

Visa Sponsorship

Security clearance