JOB SUMMARY/ESSENTIAL JOB FUNCTIONS:

Under the direction of the Director of the Plough Center the Microbiology Manager will lead the microbiology team along with providing hands-on assistance for all testing procedures. This position is responsible for the timely and accurate completion of all cGMP required microbiology testing, insure routine follow-up of static and dynamic Environmental Monitoring (EM)/Clean Utilities, raw materials, in-process and finished product testing and reports; and develop solutions to complex microbiology issues, implement, and maintain Quality Risk Management (QRM) plans for QCM Provide technical leadership to QCM staff.

DUTIES AND RESPONSIBILITIES:

1. Manages daily activities of QC Environmental Monitoring Analysts and assures that job activity deadlines are met on a timely basis.
2. Oversees the training of QC department personnel. Assures that steps are taken to maintain positive personnel morale and development.
3. Assures execution of monitoring and testing programs to assess the quality of raw materials, components, in-process and finished goods, environmental systems/utilities systems and effectiveness of production processes.
4. Oversees and if needed hands on testing of Water for Injection (WFI) routine sample testing for bioburden, sterility, conductivity and TOC (Total Organic Content).
5. Generates new/revises Standard Operating Procedures for Environmental Monitoring and Microbiology test procedures and other areas of microbiology routine testing and drug product release testing.
6. Ensures that raw materials, components, products, or monitoring results that do not meet specifications or expectations are promptly investigated.
7. Identifies adverse microbial quality trends by preparing and analyzing Environmental Monitoring summary reports.
8. Reviews work performed by department staff for accuracy, completeness and conformance to GMP and product specifications.
9. Supervises the day-to-day technical work and line management of new employees and mentor their technical and professional development.
10. Identifies potential risks prior to launch and lead efforts to find solutions and determines suitable controls strategies.
11. Performs other duties assigned.