Quality Control Microbiology Manager

Quality Control Microbiology Manager needed! Summary:The Manager, Quality Control (QC) Microbiology, is responsible for oversight of day-to-day microbial QC operations at Cell Therapy Center (iCTC). The role will be responsible for working in a GMP- regulated environment and have good understanding of QC microbiology test methods and environmental monitoring. This role must be able to apply phase appropriate cGMPs and regulatory requirements in the product development life cycle, including but not limited to: lot release and stability testing, method qualification and validation, method technology transfers, and writing/review of QC procedures.Shift: Monday to Friday from 11:00pm to 7:30amEssential Functions and Responsibilities:Manage several analysts at the iCTC in the day-to-day cGMP QC testing of drug products for lot release and stability; Manage microbial testing at contract laboratoriesManage the technical transfer, qualification, and validation of microbiology test methods for in- process materials, lot release, and/or stability, as neededManage the environmental monitoring program for the facilityAuthor, review, and approve SOPs, protocols, reports, specifications, and other quality control documents.Ensure trend analysis and trend reports for environmental monitoring data are performed timely.Lead investigations for out-of-specification test results, corrective actions, and verification of effectiveness.Support product stability programs including generation of stability protocols, execution of stability testing, stability data analysis, and final reporting of stability data.Support of site contamination control programs.Oversee the maintenance and built of a microbial identification database for all in-house isolates recovered from the various monitoring programs.Ensure trend analysis and trend reports for environmental monitoring data are performed timely.Support site qualification/validation/commissioning activities, as needed.Serve as a qualified trainer, as needed.Support career development of microbiology team members.Establish positive working relationships with internal and external partners, and implement processes for performance management, including routine meetings, onsite visits, performance monitoring, and issue notificationSupport problem solving for technical issues pertaining to GMP quality control, working alongside technical SMEs as neededOperate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environmentAll duties are performed with minimal supervision and oversightRequired Education, Skills, and Knowledge:Bachelors degree in a relevant discipline (biological sciences or equivalent)Minimum (8) years of experience in the biopharmaceutical industry within a Quality Control role Experience managing a team a plusBroad knowledge of biological drug development with respect to Quality ControlDemonstrated ability to manage external partners with respect to quality control activities Successfully interface with multi-disciplined teams in a global settingExtremely detail-oriented with strong analytical, written, and verbal communication skillsAbility to effectively manage multiple priorities involving aggressive timelines at a high level of productivityDemonstrate sense of urgency; ability to recognize time sensitivityFlexible and adaptable style with an eagerness to take on challengesProblem solver who not only identifies issues but leads efforts to resolve themPreferred Education, Skills, and Knowledge:Experience with cell therapy products

Created: 2024-11-01