Lead Microbiologist

Our client is an established pharmaceutical company and is looking for a Lead Microbiologist to join their team.

Salary/Hourly Rate:

$90k – $105k Depending on experience

Position Overview:

The Lead Microbiologist will manage the company’s microbiological protocols to ensure that the manufacturing facilities and labs are in compliance with all necessary guidelines. The Lead Microbiologist will implement and maintain microbiological validation protocols to ensure laboratory compliance with industry regulations and company standards.

Responsibilities of the Lead Microbiologist:

• Develop and create validation protocols for method suitability, equipment validation, and environmental monitoring.
• Overseeing environmental monitoring programs, including air, water, cleaning, sanitization, and surface testing to ensure hygiene standards are met.
• Write or update Standard Operating Procedures to align with company and regulatory requirements.
• Conduct regular audits of laboratory practices and documentation to identify areas for improvement and implement necessary corrective actions.
• Work closely with other departments (R&D, Manufacturing, Quality, and Engineering) to assist with environmental and laboratory program activities.
• Prepare scientifically sound investigations for laboratory issues, non-conformances, and corrective action/preventive action (CAPA) reports.
• Assist with inspections and audits conducted by external agencies when needed.
• Lead investigations into microbiological contamination incidents in the laboratory and/or manufacturing, identify root causes, and implement corrective and preventive measures.
• Review, analyze, and write environmental monitoring data reports, identifying opportunities for improvement and areas requiring revalidation.
• Provide training and guidance to plant personnel on best practices for maintaining a clean and safe production environment.
• Lead daily cGMP assessments with cross-functional teams to ensure compliance with manufacturing practices, track observations, and monitor improvements until closure.
• Coordinate maintenance schedules and create schedules for machine cleaning and third-party cleaning services.

Qualifications for the Lead Microbiologist:

• 5+ years of experience in microbiology at a pharmaceutical or personal care manufacturer.
• Strong knowledge of microbiology testing and validation protocols.
• The Lead Microbiologist should have excellent leadership and communication skills.
• Knowledge of GMP regulations.

Education Requirements:

• Bachelor’s or Master’s degree in Biology, Microbiology, Biological Sciences, or a related science is preferred for the Lead Microbiologist.

Benefits:

• Medical, dental, and vision insurance.
• PTO.
• 401k and more.

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EOE/M/F/D/V/SO