$80K - $90K/yr
Full-time
Posted 2 hours ago
Job description
Position Summary
The Microbiology Manager is responsible for leading and overseeing all microbiological operations within Medivant’s 503B pharmaceutical outsourcing facilities. This role ensures compliance with FDA regulations, cGMP standards, USP requirements, and internal quality systems while supporting sterile manufacturing through effective environmental control, microbiological testing, contamination prevention, and continuous improvement initiatives.
The ideal candidate will provide leadership to the microbiology team, maintain inspection readiness, and collaborate cross-functionally with Quality Assurance, Manufacturing, and Validation teams to ensure product quality and regulatory compliance.
Key Responsibilities
Provide leadership and oversight for all microbiological programs including Environmental Monitoring (EM), Personnel Monitoring (PM), Sterility Testing, Endotoxin Testing (BET), Bioburden Testing, and Microbial Identification.
Supervise, train, mentor, and develop microbiology staff while ensuring adherence to cGMP standards, aseptic practices, and ISO cleanroom requirements.
Review, approve, and trend microbiological data including EM/PM results, sterility testing outcomes, and microbial identification reports.
Lead investigations related to OOS, OOT, contamination events, and environmental excursions, ensuring timely closure and implementation of CAPAs.
Support qualification and validation activities including microbiological methods, disinfectant efficacy studies, sterilization cycles, and cleanroom controls.
Partner closely with Quality Assurance and Manufacturing teams to provide microbiological guidance for aseptic processing and contamination control strategies.
Serve as Subject Matter Expert (SME) during FDA inspections, customer audits, and regulatory reviews.
Ensure laboratory readiness through proper inventory management of media, reagents, consumables, and equipment.
Develop, review, and approve SOPs, protocols, validation reports, and technical documentation related to microbiology operations.
Maintain training programs to ensure staff competency, compliance awareness, and aseptic qualification standards.
Evaluate and implement new technologies, testing methods, and process improvements to enhance quality, efficiency, and compliance.
Promote a culture of safety, quality, accountability, and data integrity (ALCOA+ principles).
Qualifications
Required:
Bachelor’s degree in Microbiology, Biology, or related scientific field.
6–10+ years of pharmaceutical microbiology experience, preferably within sterile manufacturing or 503B outsourcing facilities.
Strong knowledge of cGMP regulations and USP chapters including <71>, <61>, <62>, <85>, <1116>, and <797>/<800> as applicable.
Proven experience managing microbiology laboratory operations, environmental monitoring programs, sterility assurance, and investigations.
Hands-on experience with CAPAs, Change Controls, Deviations, OOS/OOT investigations, and audit readiness.
Strong leadership, communication, organizational, and technical writing skills.
Preferred:
Master’s degree in Microbiology, Biology, or related scientific field.
Experience with electronic Quality Management Systems such as MasterControl, Progen, or similar platforms.
Previous experience supporting FDA inspections or regulatory audits in a pharmaceutical environment.
Key Competencies
Leadership & Team Development
Regulatory Compliance & Inspection Readiness
Technical Expertise in Microbiology
Problem Solving & Root Cause Analysis
Data Integrity & Quality Focus
Cross-Functional Collaboration
Continuous Improvement Mindset
Please note that we are not providing H1B visa sponsorship for this role. Candidates will be solely responsible for managing and maintaining their own visa sponsorship status.
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Frequently asked questions
Q: What skills or qualities help someone succeed as a Microbiology Manager?
A: To succeed as a Microbiology Manager, key technical skills include expertise in microbiological testing methods, quality control procedures, and regulatory compliance (e.g., FDA, ISO 17025). Soft skills such as strong communication, leadership, and problem-solving abilities are also crucial, as they enable effective collaboration with cross-functional teams, data-driven decision-making, and strategic planning. By combining these technical and soft skills, a Microbiology Manager can drive quality improvement, ensure regulatory compliance, and advance their career through leadership opportunities and professional development.
Q: What is the career path for a Microbiology Manager?
A: A Microbiology Manager typically starts as a Microbiologist or Quality Control Specialist, progressing to roles such as Senior Microbiologist, Quality Assurance Manager, and eventually, Microbiology Manager, overseeing laboratory operations and ensuring compliance with regulatory standards. Key opportunities for skill development include staying up-to-date with industry regulations, developing leadership and communication skills, and expanding knowledge in areas like microbiological testing, quality control, and risk management. Long-term career prospects may include transitioning into senior leadership roles, such as Director of Quality or Laboratory Operations, or pursuing specialized roles like Regulatory Affairs Specialist or Consultant in the pharmaceutical, biotechnology, or food industries.
