Bachelor's degree in Life Science (B.Sc. in microbiology or biology preferred) with 7-9+ years' experience in a cGMP laboratory/production environment, or Master's degree with 5-7+ years' experience.
3-5 years of supervisory and people management experience required.
Cleanroom experience essential.
Must have knowledge to oversee the metrology of microbiology equipment.
Familiarity with US, EU, and global regulations necessary.
Ability to write, review, and revise Standard Operating Procedures (SOPs) required.
Knowledge or experience with Lean Six Sigma preferred.
Proficiency in MS Office applications required.
Responsibilities
Manage and maintain environmental monitoring and sterility assurance programs.
Develop and manage departmental KPIs for safety, quality, and performance.
Supervise departmental resources and personnel, conducting routine performance meetings.
Organize daily laboratory and environmental monitoring activities for the team.
Evaluate environmental monitoring results for trends indicating microbial control issues.
Oversee sterile gowning and gowning validation programs, ensuring compliance with ISO standards.
Lead investigations into microbiology and sterility assurance issues, providing expert guidance for corrective actions.
Manage finished product release testing for sterility, endotoxin, and particulate matter.
Benefits
Collaborative work environment with opportunities for professional development.
Access to advanced laboratory technologies and methodologies.
Chance to lead and innovate in microbiology practices tailored to pharmaceutical needs.
Support for continuous process improvement initiatives within the department.
Exposure to compliance practices under multiple regulatory frameworks (FDA, EU regulations).
The Microbiology - Environmental Monitoring Manager supports manufacturing activities at the NJ5 site by (1) detecting, quantifying, identifying and investigation possible contaminants that may impact the quality of product during different stages of the manufacturing process, (2) establishing and monitoring the state of microbiological control at the site, (3) assessing aseptic behavior and practices of site personnel and assessing the effectiveness of cleaning and sanitization programs at the site, and serving as site expert on the pharmaceutical/industrial microbiology.
Essential Duties and Responsibilities
Manages and maintains site environmental monitoring and sterility assurance programs by leading development, qualification and training efforts for Environmental Monitoring (EM), cleaning and sanitization, classified area gowning, media fills, and microbiology testing (including, but not limited to, sterility, endotoxin, microbiology method suitability, growth promotion, and isolate identification).
Develop and manage departmental KPI for Safety, Quality and deliverables including but not limited to annual performance goals.
Manages departmental resources and personnel, performs routine 1:1 meeting with direct reports, year-end reviews, and prepares team members for growth and advancement. Efficiently schedules resources, prioritizing between projects, clinical manufacturing, Quality needs, and other facility related tasks requiring control over aseptic conditions and environmental monitoring needs.
Manages and supervises, schedule and organize daily laboratory and EM activities for microbiologists and technicians.
Oversee and engage with the site environmental monitoring (EM) program including developing and maintaining sampling schedules in accordance with procedures, performing sampling of rooms, equipment, and personnel, and performing EM sample management from incubation through isolate ID and completion of EM documentation. Evaluate EM results for trends that may indicate declining microbiological control of the GMP production environment. Complete or oversee the completion of EM quarterly trend reports.
Oversee and engage with sterile gowning and gowning validation program at NJ5. Leads by example by maintaining gowning validation and other qualifications as necessary to enter ISO 7 production areas and ISO 5 enclosures for the purpose of performing EM and evaluating aseptic practices. Oversee and engage with the qualification of laboratory equipment at NJ5, specifically, but not limited to microbiology testing and EM equipment. Ensure that equipment is always maintained in a compliant manner.
Manage, lead and participate as a subject matter expert with development, testing, deployment and training for EM, gowning, analyst qualification, and cleaning process workflows in Laboratory Information Management System (LIMS).
Manage and lead microbiology, sterility assurance and other departmental investigations, including out of specification results associated with sterility or media fill failures, determining root cause, and providing expert guidance on required corrective actions. Review relevant trends (e.g., environmental monitoring, cleaning, sanitization, etc.) to initiate corrective and preventive actions and/or for continuous process improvement.
Manage finished product release testing such as sterility, endotoxin, and particulate matter. Perform as required
As applicable to support investigations, the ability to perform precise production visual inspection or laboratory appearance testing of finished product requiring 20/20 vision and accurate color differentiation (with or without reasonable accommodation) to assess product quality by evaluating color, clarity and absence of visible particulates for the drug product solution and evaluating attributes of the container closure system (e.g., cracks or chips in glass vials, creases in crimps, presence of stoppers, color of flip tops, etc.) in compliance with FDA, EudraLex and Rest of World guidance. These skills are also necessary to ensure detection of visual contamination in EM and other media samples.
Support aseptic process simulation activities by participating in media files and by leading (or performing or coordinating) all subsequent incubation, growth promotion, and assessment efforts.
Manage external laboratory testing. Lead and coordinate all subcontracted B/F, growth promotion and isolate ID activities, including sample control and tracking, defining testing requirements, and assuring subcontracted laboratories are aware of target completion dates.
Manage and oversee departmental inventory of EM and other lab required materials required for finished product testing and media fills Partner with the Production Manager/Scheduler to ensure adequate inventories are ordered and maintained. Proactively set up sufficient and timely order frequency to allow for completion of subcontracted or internal release testing. Enable teams to perform periodic inventory of laboratory materials and supplies.
Write, review, approve, and implement procedures, specifications, processes, and methods as required.
Conduct reviews of aseptic operations to ensure compliance with the internal procedures (e.g., gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and 21 CFR 211, EudraLex Volume 4 Annex 1, and other global regulations and guidance.
Work cooperatively with the corporate Director of Sterility Assurance to develop, evaluate, and maintain site Sterility Assurance initiatives. Also, as needed, participate in network Microbiology/Sterility Assurance initiatives and investigations. Collaborate cross functionally to enhance sterility assurance at site level.
Liaise with internal and external inspectors and representatives, as the site Microbiology expert. Practice continuous Improvement across the laboratory and identify opportunities to bring in-house and reduce external lab microbiological testing.
Liaise with clients to manage projects and serve as SME for microbiology, media fills and sterility testing.
Perform other responsibilities as required.
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 performing 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 including performing microbiological testing and environmental monitoring. 3-5 years of Supervisory and people management experience is a must.
Cleanroom experience is a must.
Knowledge to oversee metrology of microbiology equipment is required.
Knowledge of US, EU and other global regulations.
Knowledge of how and ability to write, review, and revise SOPs required.
Knowledge or experience with Lean Six Sigma preferred.
Ability to read, analyze, and interpret governmental regulations, professional journals, or technical procedures required.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.
Ability to effectively present information, deliver training, and respond to questions from groups of managers, clients, customers, and the general public required.
Ability to define problems, collect data, establish facts and draw valid conclusions required.
Ability to solve problems and handle issues required.
Proficiency in MS Office applications required.
Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors are required.
As applicable, 20/20 natural or corrected vision and normal color vision, only for performance of visual inspection or appearance testing.
