Pennington, NJ- fully onsite

Permanent, full time position

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

Oversight: Responsible for risk identification, developing and implementing strategies to control microbiological risks in raw materials, production processes and finished products.

Manage Laboratory Activities: Oversee microbiology laboratory activities including testing, method validation/verification, equipment validation, cleaning validation, environmental monitoring performance qualification (EMPQ), microbial identification and environmental monitoring.

Problem Solving: Resolve technical problems in the lab. Lead investigation for out of specification results and EM nonconformance.

Team Leadership: Supervise and support a team of microbiologists and other professionals. Train laboratory personnel to ensure they are well versed in microbiological procedures.

Compliance: Ensure all laboratory activities comply with GMP and regulatory requirements. Oversee CAPAs, deviations, and change controls within Microbiology group.

Documentation: Develop, review and update SOPs, protocols and reports related to microbiological testing and processes.

Data Management: 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. Familiarity with LIMS for data tracking and management.

Client and Audit Management: Subject matter expert in microbiology for regulatory and client audits for GMP compliance.

Qualifications

Education: Bachelor’s Degree in Science or related field.

Experience: 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.

Skills: 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.