Manager - Microbiology & Environmental Monitoring

About the role

The Microbiology – Environmental Monitoring Manager supports manufacturing activities at the NJ5 site by detecting, quantifying, identifying, and investigating possible contaminants that may impact product quality during manufacturing; establishing and monitoring microbiological control; assessing aseptic behavior and practices; and serving as the site expert on pharmaceutical/industrial microbiology.

Responsibilities

• Manage and maintain site environmental monitoring and sterility assurance programs, including development, qualification, and training for EM, cleaning and sanitization, gowning, media fills, and microbiology testing (sterility, endotoxin, method suitability, growth promotion, isolate identification).
• Develop and manage departmental KPIs for Safety, Quality, and deliverables, including annual performance goals.
• Manage departmental resources and personnel, conduct routine 1:1 meetings, year-end reviews, and prepare team members for growth and advancement.
• Schedule resources efficiently, prioritizing projects, clinical manufacturing, Quality needs, and facility tasks requiring aseptic control and EM oversight.
• Supervise daily laboratory and EM activities for microbiologists and technicians.
• Oversee the site EM program: develop and maintain sampling schedules, perform sampling of rooms, equipment, and personnel, manage EM sample workflow from incubation through isolate ID and documentation, evaluate trends indicating declining microbiological control, and complete quarterly trend reports.
• Oversee the sterile gowning and gowning validation program; maintain gowning validation and qualifications to enter ISO 7 and ISO 5 areas for EM and aseptic practice evaluation.
• Oversee qualification of laboratory equipment, ensuring compliant maintenance of microbiology testing and EM equipment.
• Manage, lead, and participate as a subject matter expert in development, testing, deployment, and training for EM, gowning, analyst qualification, and cleaning workflows in LIMS.
• Lead and participate in microbiology, sterility assurance, and departmental investigations, including OOS results and media fill failures; determine root cause and guide corrective actions; review trends to initiate CAPAs and process improvements.
• Manage finished product release testing (sterility, endotoxin, particulate matter) and perform visual inspection and appearance testing as required.
• Support aseptic process simulation by participating in media fills and leading incubation, growth promotion, and assessment efforts.
• Manage external laboratory testing: coordinate subcontracted bioburden/sterility, growth promotion, and isolate ID activities, including sample control, tracking, and ensuring target completion dates.
• Manage departmental inventory of EM and lab materials for finished product testing and media fills; partner with Production to maintain adequate inventories and enable periodic inventory checks.
• Write, review, approve, and implement procedures, specifications, processes, and methods as required.
• Conduct reviews of aseptic operations to ensure compliance with internal procedures and global regulations (21 CFR 211, EudraLex Annex 1).
• Collaborate with the corporate Director of Sterility Assurance and participate in network initiatives to enhance sterility assurance at the site.
• Liaise with internal and external inspectors as the site Microbiology expert; identify opportunities to bring in-house microbiological testing and reduce external lab reliance.
• Liaise with clients to manage projects and serve as SME for microbiology, media fills, and sterility testing.

Qualifications

• Bachelor’s degree in a Life Science discipline (B.Sc. in microbiology or biology preferred) and 7–9+ years in a cGMP laboratory/production environment including microbiological testing and environmental monitoring; or Master’s degree in a Life Science discipline (microbiology or biology preferred) and 5–7+ years in a cGMP laboratory/production environment.
• 3–5 years of supervisory and people management experience required.
• Cleanroom experience required.
• Knowledge to oversee metrology of microbiology equipment required.
• Knowledge of US, EU, and other global regulations required.
• Ability to write, review, and revise SOPs required.
• Lean Six Sigma knowledge/experience preferred.
• Ability to read, analyze, and interpret governmental regulations, professional journals, and technical procedures.
• Ability to read and interpret safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to present information, deliver training, and respond to questions from managers, clients, and inspectors.
• Ability to define problems, collect data, establish facts, draw conclusions, and solve issues.
• Proficiency in MS Office applications required.
• Strong interpersonal communication skills for interactions with site personnel, inspectors, and vendors.
• As applicable, 20/20 natural or corrected vision and normal color vision for visual inspection and appearance testing.