Job Description
Our client, a dynamic biopharmaceutical company with a global footprint in both R&D and manufacturing, is seeking a Microbiology Manager to join their growing team on a contract to hire basis.
Job Title: Microbiology Manager
Job Type: Contract to Hire
Location: Middlesex County, NJ
Rate: $48-$50/hr
Position Summary:
The Microbiology Manager will play a critical leadership role within the Quality organization, supporting departmental strategy and serving as a subject matter expert in microbiology. This individual will oversee day-to-day microbiological testing activities—including product release, validation support, and environmental monitoring—while supervising and developing a team of microbiologists in a GMP-compliant pharmaceutical or biotechnology environment.
Key Responsibilities:
- Lead and coordinate microbiological testing activities, including product release and protocol-driven validation testing.
- Supervise, train, and mentor microbiology staff; provide performance feedback and development planning.
- Conduct and review microbial identification and provide technical expertise on microbiological testing methodologies.
- Oversee and interpret environmental monitoring (EM) results, sterility testing, growth promotion, microbial limits, and other critical microbiological assays.
- Review batch records, laboratory data, EM reports, and equipment logs to ensure compliance with cGMP, FDA, and company quality standards.
- Participate in or lead method validation, troubleshooting investigations, and the development and revision of SOPs and quality documentation.
- Ensure laboratory operations remain in a state of audit readiness; generate regular reports and manage documentation lifecycle.
- Collaborate cross-functionally with Quality Assurance, Manufacturing, and Regulatory Affairs to support business objectives and ensure timely product release.
- Promote a culture of safety, compliance, and continuous improvement within the laboratory.
Required Qualifications:
- Bachelor’s degree in Microbiology, Biology, or a related scientific field (Master’s preferred).
- 10+ years of experience in microbiology or quality control within a GMP-regulated pharmaceutical or biotech setting.
- At least 3–4 years of supervisory or managerial experience with direct reports.
- Demonstrated expertise in environmental monitoring programs and aseptic processes.
This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!