Manager, Microbiology

DUTIES AND RESPONSIBILITIES This position is responsible for leadership and management of the QC Microbiology (QCM) Team. The QCM team is responsible for microbiological testing of product and raw materials, environmental monitoring and development /validation of microbiological test procedures. The position provides technical leadership, direction and guidance to Operations on aseptic processing controls, microbial control and related regulatory requirements and is also responsible to support Operations by ensuring that all testing, disposition, investigation resolution and other activities are performed in a safe, high quality, efficient and timely manner. The incumbent ensures all activities are performed and documented according to required procedures, regulatory submissions and cGMPs. The position provides technical input to the CMC section of regulatory submissions. Provides leadership to ensure that QC microbiology testing and other activities are performed in a safe, high quality, efficient and timely manner to support raw material and product release, stability testing, utility testing and qualification of new /revised products and processes. Manages and prioritizes laboratory activities and test scheduling. Ensures proper support for validation of processes, systems, and methods. Provides technical guidance and direction to QCM team regarding QCM system requirements and compliance. This includes calibration, maintenance and validation of test equipment, validation and technical transfer of microbiological test methods, validation of QCM computerized systems, process validation support and regulatory requirements. Process validation support includes media fills, gowning qualification, SIP qualifications, sanitization methods qualification, etc. Provides technical leadership, direction and guidance to Dey Operations on matters of aseptic processing control requirements, microbial control, microbiology testing technologies, laboratory GMP and microbiology related regulatory requirements. Provides input to CMC sections of regulatory submissions. Oversees final review of microbiological testing and reviews /approves test and procedure non-conformance investigations to ensure these activities are performed properly according to Dey procedures, specifications and regulatory requirements. Provides input to non-conformance investigations and dispositions nonconforming product as needed. Provides direction in troubleshooting by applying scientific knowledge. Ensures proper maintenance and control of datasheets, laboratory notebooks, logbooks, procedures and other documentation. Prepares, reviews and approves new /revised procedures, test methods, specifications, protocols and reports. Reports include test summary reports and microbiological testing trend reports. Prepares raw material and product investigations, microbiological test reports, and monthly reports. Performs coaching and mentoring to support development of QCM team members. Monitors performance of team members and provides feedback including formal performance appraisals. Facilitates training and education to ensure all QCM team members are capable, properly trained and qualified to perform their work tasks. Designs and administers training and development plans for subordinates. Conducts performance appraisals of subordinate employees. Oversees training, and proper use of equipment. Ensures departmental compliance with regard to GMPs, housekeeping and safety requirements. Provides leadership in management of internal and external audits including those performed by the Food and Drug Administration and other regulatory authorities. Interacts with auditors and responds to observations and recommendations. Participates in monthly safety and housekeeping audits. Consults with executive management. Provides input on business direction. Prepares budget proposals for capital, expense, and census for the Microbiology department. Provides leadership to drive continuous improvement in QCM department operations as well as support initiatives in Operations. Serves as a back-up to the QC Director and QCM supervisors. REQUIRED EDUCATION/EXPERIENCE/SKILLS BS degree in biological science (Microbiology preferred). Advanced degree in Microbiology preferred. At least five years of pharmaceutical industry experience. At least two years of supervisory /management experience. Excellent verbal and written communication skills. Strong interpersonal/group skills with ability to motivate and direct others. Work experience and accomplishments demonstrate strong technical competency Strong knowledge of regulations and guidelines concerning aseptic processing, sterilization, environmental monitoring, microbial control for pharmaceutical manufacturing, advanced microbiological test methods, and microbiological related process validations. Strong knowledge of cGMPs, USP/NF, CFR, validation guidelines, FDA guidelines and other applicable regulatory requirements. Strong analytical ability and problem solving skills. Strong computer skills: Experienced with typical office software including spreadsheets, database, etc. Strong knowledge of modern microbiological test methods including sterility testing employing isolator technology, advanced microbiological identification instrumentation such as Microlog, Vitek, MIDI, RiboPrinter, etc. DEY supports diversity in the work place. We are an Equal Opportunity Employer.