Title Microbiologist II, RCM

Location Totowa, New Jersey

Department Radiopharmaceutical Contract Manufacturing

Overview The Microbiologist II /Environmental Monitoring Specialist (EMS) supports manufacturing activities at the RCM-NJ5 site by (1) detecting, quantifying, identifying and investigating 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, and (3) assessing aseptic behavior and practices of site personnel and assessing the effectiveness of cleaning and sanitization programs at the site.

Essential Duties and Responsibilities

Responsible for the site environmental monitoring (EM) program by maintaining sampling schedules in accordance with procedures, performing sampling of rooms, equipment and personnel.

Perform EM sample management in LIMS in addition to all media / sample growth promotion, subsequent incubations, result reads/ interpretation, isolate ID, and completion of EM documentation.

Initiate and perform investigations as directed, determine root cause and provide expert guidance on required corrective actions for EM excursions. Evaluate EM results for trends that may indicate declining microbiological control of the GMP production environment.

As directed, draft / revise / review SOP's, protocols, and implement procedures, specifications, processes, and methods as required.

Peer review the work of other Microbiologist II, Microbiologist I, EM Tech, or QC Tech.

Provide training to junior Microbiologist and EM technicians or designees.

Identify and perform stability and microbiology lab improvements: assist in or lead any such improvement projects.

Assist in business enhancements opportunities such as establishing growth promotion and isolate ID programs at NJ5. Become an expert on workflow for new capabilities and train junior microbiologists and EM techs.

Serve as backup to all responsibilities of Microbiologist III/Manager and relevant microbiology personnel.

Attend meetings and 1:1s with Microbiology / QC management.

Support finished product release by performing sterility, endotoxin, and particulate matter testing (as required). Perform basic QC testing as required.

Maintain initial and annual gowning validation and other qualifications as necessary. This includes initial training and retraining for aseptic gowning.

Support aseptic process simulation activities by participating in media fills to enter ISO 7 production areas and ISO 5 enclosures.

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.

Test method development, transfer, and validation projects.

Support inventory management program for EM, Media fills and release testing materials and consumables. Continuously work with Production personnel / Schedular and warehouse manager to order and maintain adequate inventory at all times. Manage external laboratory program for the department.

Perform sterility failure and media fill failure investigations, if needed. Perform other sterility assurance and microbiology related investigations.

Support lab audits, gemba and safety walk throughs as the site Microbiology expert.

Ensure data integrity and compliance of all microbiology testing equipment, incubators, and laboratory.

Review job relevant trends (e.g. environmental monitoring, cleaning, sanitization, etc.) to initiate corrective and preventive actions and/or for continuous process improvement.

Conduct review of aseptic operations to ensure compliance to internal procedures (e.g. gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations.

Ensure compliance to all applicable standard operating procedures and regulations, including 21 CFR Part 211 and Eudralex Volume 4 requirements.

Other responsibilities as required.

Qualifications

Bachelor's Degree in a Life Science discipline (B.Sc. in microbiology or biology preferred) and 5 years in a cGMP laboratory/ production environment including performing environmental monitoring, or Master's Degree in a Life Science discipline (microbiology or biology preferred) and 3 years in a cGMP laboratory/ production environment including performing environmental monitoring.

Knowledge of USP, FDA, and cGMP regulations preferred.

Knowledge of how and ability to write, review, and revise SOPs required.

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 make critical decisions backed by data.

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 required.

Knowledge of Lean Six Sigma methodologies would be a plus.