Associate Director, Quality Control Microbiology

Overview Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large. The Associate Director of QC Microbiology will provide strategic, technical, and operational leadership for QC Microbiology related activities. The individual will proactively identify and implement industry standard methodologies for Quality Control Microbiology Laboratories. Such efforts are related to rapid microbiological methods, media simulations and inspection requirements, gowning qualifications, aseptic operator qualifications, facility sanitization and cleaning, investigation assistance and continuous improvement plans. Position Summary: The Associate Director of QC Microbiology will provide strategic, technical, and operational leadership for QC Microbiology related activities. The individual will proactively identify and implement industry standard methodologies for Quality Control Microbiology Laboratories. Such efforts are related to rapid microbiological methods, media simulations and inspection requirements, gowning qualifications, aseptic operator qualifications, facility sanitization and cleaning, investigation assistance and continuous improvement plans. The Associate Director will provide guidance to the continuous improvement of Environmental Monitoring trend analysis, data integrity, assurance practices for lab information and on the floor laboratory oversight support. This individual will partner with Manufacturing Business Leaders to drive improvement in aseptic process controls, customer satisfaction and continuous improvement initiatives consistent with the Site Strategic Plan and Fujifilm Diosynth Biotechnologies values. Individuals in this role have expert understanding in strategic leadership, verbal and written communication, project management, time management, and demonstrate expert understanding in critical thinking and problem solving. In addition, role model company core values of trust, delighting our customers, Gemba, and Genki. Primary Responsibilities Lead and develop a team of individuals in alignment with department’s objectives. Provide QC Microbiology oversight for the facility startup, including qualification and validation activities. Responsible for immediate escalation of issues that could impact product quality, safety and/or efficacy to site leadership. Oversees the development and implementation of standards, methods, procedures, and sampling for environmental monitoring. Manage the Environmental Monitoring Program and Aseptic Gowning Qualification Program. Participate actively in the revision of procedure, methods, and processes for clarity and enhancement. Lead inspections by regulatory agencies or clients for microbiological topics. Support cGMP manufacture, testing, and supply of high-quality cell therapy products. Develop phase-appropriate QC Microbiology capabilities, business processes, and procedures. Coordinate execution of disinfection effectiveness studies. Develop and sustain QC Key performance indicators and metrics. Manage continuous improvement projects that may span multiple sections or departments with the objective of achieving quality, reliability, and cost improvements. Actively supports/directs strategies to continuously improve laboratory processes and results. Ensure adequate inventory of laboratory media and supplies required to perform testing. Manage overall coaching, training, development, and succession plans for the team. Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure that the QC Microbiology function remains in compliance with applicable company requirements and global regulations. Interact with the site management team to identify QC Microbiology requirements in support of New Product Introduction at the site and improvement measures. Provide technical support to laboratory investigations and trend investigations, including the identification of Corrective/Preventive Actions to prevent recurrence. Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines. Partners with critical contract laboratories to resolve issues in microbiology method, collaborating with customer/partner quality organizations, and assisting with third-party contractor and supplier quality agreement. Responsible to drive and support a strong quality culture at the site. Position Requirements/Qualifications Mastery knowledge working within a GxP regulated environment. Mastery knowledge of aseptic techniques, and aseptic gowning. Mastery knowledge of document management and lifecycle. Mastery knowledge of quality systems and their interconnections (e.g., LIMS and document revisions). Mastery knowledge in microbiological methods and respective instrumentation, including RAPID Microbiology Methods such as Sterility, Mycoplasma. Advanced knowledge of computer systems (e.g., Word, Excel, LIMS). Advanced knowledge of regulations (US, EMA, and ICH regulations and guidance method) and inspection/audit readiness. Advanced knowledge of QMS (CAPA, deviation, change control, laboratory investigation). Advanced knowledge of executing methods (e.g., casual factor analysis) for qualification, transfers and validation. Education and Professional Experience 8+ years of team management experience. Bachelor of Science (B.Sc.) with 10+ years of experience or an equivalent combination of education; or Master of Science (M.Sc.) with 7+ years of experience; or PhD in Science with 5+ years of experience. Salary and Benefits: $170,000 to $180,000 per year, depending on experience. Medical, Dental and Vision. Life Insurance. 401k. Paid Time Off.

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