Principal QC Specialist Analytical

As the global biologics research and development arm of AstraZeneca, MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic including respiratory, inflammation, and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines.

Those who join the Global Biologics Operations team feel a sense of ownership about their future. They thrive with a recognized leader in biologics manufacturing. Here, you will join passionate professionals who advance science and technology to deliver products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities... that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/metabolic disease and neuroscience. Explore a career in the biologics manufacturing field, as we strive to better more lives, more often, around the world.

* Responsible for establishing and maintaining an analytical testing function within a cGMP Quality Control environment. * Testing will include raw material, in-process, lot release, and stability support. * This functional area will be responsible for a diverse set of analytical technologies including chromatography, electrophoresis, PCR, ELISA, cell-based bioassay, and general chemistry methods. * Responsible for assisting in the implementation and maintenance of quality control systems and activities, procedures, support of production and facility activities, and project management. * Ensures programs are designed to meet cGMP requirements in support of large molecule bulk drug manufacturing. * Will assist in the training of staff in various analytical techniques, processes, and applicable Quality Systems. * Responsible for participating in investigations of analytical and process results. * Has responsibility for the implementation of the Corporate policies at the manufacturing site as they apply to this functional area. * Responsible for presenting programs and data to regulatory auditors. * Designs and implements process improvements to increase efficiency and productivity of operations utilizing Operational Excellence techniques. * Oversees implementation of the testing programs and processes at the site. * Ensure that day-to-day QC operations are run efficiently. * Ensure that programs and procedures are compliant with the cGMP standards established by the company and relevant regulatory agencies. * Manage and execute method transfers, validations, and verifications. * Troubleshoot day to day assay performance issues * Assist in development and management of processes which coordinate testing internally and at contract testing laboratories. * Proactively identify corrections and improvements required, developing solutions and leading their implementation. * Ensures that projects are completed on schedule and within budget. * Exerts influence in the development of overall objectives and long range goals of the organization. * Frequent contacts with stakeholders concerning results, projects, operational decisions, scheduling requirements, and investigations. * Author regulatory document sections related to testing methods utilized * When required, performs deviation investigations and/or Out-of--Specification investigations. * Reviews data generated in the laboratory prior to release of information. * Represents QC at internal, partner and external regulatory audits during laboratory tours and QC process discussions/requests * Generates Standard Operating Procedures and protocols. * Assists in validation of new equipment. Recognizes, troubleshoots, and resolves moderately complex problems with equipment or individual assays. * Responsible for on-time delivery or closure of QC owned deliverables (TrackWise records, testing plans, specifications, biennial reviews of procedures, PQR sections, regulatory submissions, KPIs, etc) with help of other management and technical specialists as needed. * Performs trending analysis as required for analytical results, OOS, analyst performance, etc. * Represent QC department on cross-functional teams delivering major projects and programs.

* 0 years of pharmaceutical or bio industry experience, with a minimum of 6 or more years or analytical testing experience in a GMP compliant environment required. * Direct experience with a diverse set of analytic technologies required. * These include chromatography, ELISA, cell-based bioassay, PCR, electrophoresis, and general chemistry. * Candidate must have an excellent working knowledge of the principles and philosophies for product testing and associated Quality systems. * Bachelors: Scientific / Biotech / Pharmaceutical * Ability to communicate within and outside the organization. * Ability to independently represent the organization in providing solutions to difficult technical issues associated with specific projects and applications. * Works under general direction and is able to find solutions independently. Present solutions for approval and able to implement. * Ability to successfully work in ambiguity. * Ability to be flexible and adaptable with changes.