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Manager / Senior Manager, Microbiology
Pennington Rocky Hill Road, Building 21 Pennington, NJ 08534 Pennington, NJ 08534 US
Job Description
Target Pay Rate: 140-160k **salary will be commensurate with experience
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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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