Duties and Responsibilities:
The Microbiologist/Environmental Monitoring Specialist supports manufacturing activities at the Progenics Somerset 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.
Oversee 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.
Perform investigations, determine root cause and provide expert guidance on required corrective actions for EM excursions, also evaluating EM results for trends that may indicate declining microbiological control of the GMP production environment.
Support finished product release by performing sterility, endotoxin (as required).
Support aseptic process simulation activities by participating in media fills as needed and by performing (or coordinating) all subsequent incubation, growth promotion, and isolate ID if needed.
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.
Overseeing the inventory of EM materials and other materials required for media fills and finished product testing, including working with the Materials Manager and Quality Assurance to ensure adequate inventories are ordered and maintained and that order frequency is timely and sufficient to allow for completion of testing before the materials are needed.
Perform sterility failure and media fill failure investigations, if needed. Perform other sterility assurance and microbiology related investigations.
Write, review, approve, and implement procedures, specifications, processes, and methods as required.
Liaise with internal and external inspectors and representatives, as the site Microbiology expert.
Work cooperatively with Site Quality Assurance and the Site Director to develop, evaluate and maintain site Sterility Assurance initiatives and investigations.
Develop and deliver training related to microbiology and sterility assurance to site personnel.
Ensure all microbiology testing equipment, incubators and facilities are maintained in a compliant manner at all times.
Evaluate test results and write reports (e.g. environmental monitoring, cleaning, sanitization, etc.) and initiate corrective and preventive actions and/or for continuous process improvement as applicable
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
Maintain gowning validation and other qualifications as necessary (including participating in media fills) to enter ISO 7 production areas and ISO 5 enclosures for the purpose of performing EM and evaluating aseptic practices.
Other responsibilities as required.
Technical Skills Required:
• Bachelor’s Degree in a Life Science discipline (B.Sc. in microbiology or biology preferred) and 7 years in a cGMP laboratory/ production environment including performing microbiological testing or 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 microbiological testing or environmental monitoring.
• 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 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 aseptic processing techniques
• Knowledge of USP, FDA, and cGMP regulations preferred