AstraZeneca Pharmaceuticals LP
Production Supervisor position available in Frederick, MD (full-time) to supervise and perform on-the-floor operations pertaining to biologics manufacture in a current Good Manufacturing Practices (cGMP) environment. Establish sequence of operations to produce product to adhere to the Master Production Plan. Administer and execute policies and procedures that typically affect individual subordinate employees. Review completed MPR’s and SPR’s to ensure Right First Time per compliance standards in a timely manner. Drive LEAN application for continuous Improvement of processing steps, eliminating waste in cost and time. Support Audit by creating document/ spreadsheets to support business reporting requirements. Collaborate with Manufacturing Process Lead to resolve problems, identify root cause, and propose process improvements through clear communication to senior management. Develop Standard Work for specified tasks. Lead multifunctional project teams. Evaluate and establish potential new interdepartmental procedures and practices. Review batch records and yield variance to identify process efficiency and accuracy. Ensure that projects are completed on schedule following established procedures and schedules. Coordinate Tier 1, shift change meetings to create cross-functional resource allocation needs for issues identified and maintain production targets.
Requirements: Bachelor’s degree in Science, Biology, Chemistry or related scientific field of study plus 5 years of progressively responsible experience as a Production Technician or other pilot or commercial biologics manufacturing role. Must be Yellow Belt certified. Must have five (5) years of progressively responsible experience with all of the following: Commercial biologics manufacturing under current Good Manufacturing Practices (cGMP) and Code of the Federal Regulations (CFR); Practical application of Current Good Manufacturing Practices (cGMPs); Utilizing and navigating SABA Cloud software; Transacting goods and receipts in SAP; Using Document Management System; Utilizing SCADA software; HMI portals using Rockwell Automation platform. Additionally, must possess two (2) years of experience in the following: Performing trouble shooting and root cause analysis; Utilizing GQCLIMS; Protein concentration analysis; Trackwise; Electronic batch records including PAS-X; and MODA. In the alternative, employer will accept a Master’s degree in a stated field of study plus 3 years of experience.
Hours: Rotating 4day/3day biweekly overnight shifts (6pm -6am) plus alternating weekends.
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.