$150,000/year - $160,000/year

15% Bonus

Full Benefits

Position Overview

• We are seeking a Manager/Sr. Manager in Microbiology to oversee the daily operations and assist in strategic direction of microbiology services.
• This role involves ensuring the quality and accuracy of microbiological testing, including environmental monitoring, microbial identification, and sterility assurance.

Key Responsibilities

• Responsible for risk identification, developing and implementing strategies to control microbiological risks in raw materials, production processes and finished products.
• Oversee microbiology laboratory activities including testing, method validation/verification, equipment validation, cleaning validation, environmental monitoring performance qualification (EMPQ), microbial identification and environmental monitoring.
• Resolve technical problems in the lab.
• Lead investigation for out of specification results and EM nonconformance.
• Supervise and support a team of microbiologists and other professionals.
• Train laboratory personnel to ensure they are well versed in microbiological procedures.
• Ensure all laboratory activities comply with GMP and regulatory requirements.
• Oversee CAPAs, deviations, and change controls within Microbiology group.
• Develop, review and update SOPs, protocols and reports related to microbiological testing and processes.
• Oversee the management and storage of microbiological data, ensuring it is accurate, securely stored and easily retrievable.
• Analyze data to identify trends and areas for improvement.
• Work with LIMS for data tracking and management.
• Work as subject matter expert in microbiology for regulatory and client audits for GMP compliance.

Qualifications

• Bachelor’s degree in science or related field.
• 7-10 years of experience in a microbiology laboratory leadership role within pharmaceutical or biotechnology industries.
• Significant experience working in a Good Manufacturing Practice environment is crucial.
• Proficiency in microbial identification, environmental monitoring, Endotoxin, Mycoplasma and sterility testing.
• Strong understanding of Rapid Microbiological test methods including BacT/ALERT and mycoplasma PCR test methods.