Job Description: The Microbiology Manager is responsible for all activities performed by the Microbiology Laboratory. These activities include but are not limited to the collection and administration of environmental monitoring data, sterility testing, utilities monitoring, and microbial identification in a 24/7 manufacturing environment. The responsibilities include providing necessary methods, procedures, guidance, and supervision to the Microbiologists as well as any other personnel working in the laboratory. The Microbiology Laboratory Manager ensures that documentation and activities in the laboratory are compliant with all applicable regulations. Responsibilities: + Direct supervision of Microbiology Laboratory to include performing regular personnel performance reviews, personnel counseling for disciplinary issues, and the approval and scheduling of vacation time + Scheduling, coordination and overseeing of routine and non-routine laboratory activities, such as sterility testing, microbial identification testing, membrane filtration, growth promotion, LAL testing, etc. to ensure timely release of raw materials, in-process, and finished products. + Responsible for the Environmental Monitoring (EM) Program and the Contamination Control Program. This includes reviewing and disposition of EM results, auditing, training and qualification of Microbiologists, and the creation and presentation of trend reports while maintain an ongoing Contamination Control Strategy. + Responsible for In-process and Finished product testing including Utility testing. This includes reviewing and disposition of test results, training and qualification of Microbiologists, and the creation and presentation of trend reports. + Manage multiple investigations to timely and efficiently meet compliance deadlines and product release dates. Ensure investigations are closed in a timely manner. Analyze process data and evaluate trends routinely and for cause. Provide communication for investigations & CAPA’s. + Determine the root causes and immediate actions for Deviations, Non-Conformances, OOS, OOT, and environmental excursion investigations by use of appropriate investigation tools in timely manner. Define and implement effective corrective and preventative actions to prevent recurrence. Collaborate with quality and manufacturing to develop, implement and track CAPA plans. + Responsible for Training Program of Microbiology Laboratory personnel in accordance to established and current procedures and assisting trainers to ensure compliance and error reduction. Perform hands-on training as necessary + Maintenance of Microbiology Laboratory equipment to include calibration, qualifications, certifications, and repairs + Write and revise laboratory procedures as needed + Write and execute Microbiology Laboratory equipment and product method validation + Review and disposition Microbiology results for product testing, the production environment, and utilities in a timely manner + Ensure laboratory supplies are ordered and maintained in compliance + Perform Facility/CMA audits on routine basis for Contamination Control Strategy/planning, assist In regulatory audits, assist in special projects + Provide technical and hands-on assistance as needed to all shifts as necessary and to other departments as requested by management. + Ensure the Microbiology Laboratory is in compliance with all applicable Standard Operating Procedures, safety, health, and cGMP Guidelines. + Participate in Ritedose and external training programs Qualifications: + Minimum of a Bachelor of Science in a Quality / Process related field or equivalent experience + Minimum of 15 years (with advanced degree, minimum of 10 years ) quality control or quality assurance within the bio-pharma, biologics, or pharmaceutical industry in Microbiology or equivalent experience. Minimum of 5 years in a managerial/supervisory role. + Experience successfully leading environmental and laboratory investigations, Root Cause Analysis (RCA), and CAPA and analyze data/information with use of statistical tools + Strong knowledge and understanding of cGMPs, USP testing methodologies, including laboratory instrumentation and procedures, and other regulatory compliance applicable to research and commercial pharmaceutical manufacturing + Knowledge of operational processes and controls in sterile pharmaceutical manufacturing with an emphasis on Contamination Control + Experience using electronic data systems preferred + Relevant IT skills for reporting and reviewing data and creating/revising documents + Ability to think strategically be detail-oriented, work in a cross-functional environment, effectively operate as a team and independently + Analytical and problem-solving skills with strong written and oral communication + Flexible and able to adapt to company growth and evolving responsibilities for a 24 hour/7-day manufacturing site + Integrity, accountability and strong dedication to regulatory compliance with continuous improvement mindset Qualifications