Manager

Job Summary The Manager, Laboratory Services is responsible for the operation of the Metrology and Instrument Qualification, IT support of Lab Equipment, Materials Management and Glassware cleaning. Responsible for managing system administration of the QCC Empower chromatographic data system (CDS), stand-alone analytical equipment and the calibration database. The Manager assures compliance of all analytical instruments per federal guidelines and corporate requirements; provides technical leadership to calibration specialists, system administrator, and validation engineers. Works closely with instrument owner departments to ensure equipment is qualified, calibrated, and maintained per predetermined schedule, with focus on minimum equipment downtime. Serves as Site Narcotic Substance Responsible (SNSR) for Cornell site. Responsibilities Manage equipment calibration program for Quality Control laboratories. Manage qualification program for analytical instruments, environmental chambers, and supporting laboratory equipment per site's Validation Master Plan. Manage department expenses, annual budget, with focus on minimizing costs through selective mix of vendor and in-house support. Manage direct reports: Metrology, Validation, Materials Management, IT Specialist. Review deviation reports, qualification protocols, new instrument registrations, 24-month SOP reviews, periodic reviews, and engineering change controls Participate with support team for on-site audits; generate responses to internal audit observations, initiate corrective action to ensure departments maintain GMP compliance. Responsible for managing controlled substance inventory and reporting. Collaborate with SNSR team monthly (at minimum) to share controlled substance related activity, audits/findings, and other relevant learnings. Coordinate all DEA communication needs with NNSR (and/or CSC Team member) prior to communicating with the local DEA office to ensure alignment. (Ex: security modification, DEA registration(s), cs and/or listed chemical product theft/loss reporting, etc.) Lead and function as the primary site contact for all DEA and State controlled substance inspections. Collaborate with NNSR, CSC Team, and Legal changes to the site's controlled substance reporting, handling, or other compliance needs (ex: new product launches, new state reporting requirements, changes in quarterly to monthly ARCOS reporting). CS Inventory Management - Review of CS raw material inventory, oversight of CS stored in the vault (for WIP and FP), ensure physical inventory matches electronic inventory, conduct year-end inventory. Coordination of Import and Export of CS - Applying for CS permits and declaration, ensure appropriate teams are aware of CS imports and exports, work with Warehouse to schedule export of CS, provide DEA required return information for imports and exports of CS, filing of CS documentation for all imports and exports. CS Waste Management - Reconciliation of CS Waste, complete necessary paperwork for DEA (and appropriate state reporting) for CS destruction. Job Requirements Bachelor's degree in chemistry, engineering, or related technical field. 5+ years of experience in the pharmaceutical industry. 1+ years of management experience Experience managing laboratory equipment, validation, and calibration programs in compliance with applicable cGMPs. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.