Senior Specialist QCSS Instrumentation

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. The Role Cruiserath Biologics are seeking to recruit a QC Shared Services Instrumentation Senior Specialist to execute Laboratory Instrumentation Purchase, Installation, Qualification and Lifecycle management. Reporting to the QC Instrumentation Team Lead, the specialist will manage the purchase and qualification of laboratory instruments and will be responsible for providing an Instrument Calibration and Maintenance service to the QC laboratory teams. The candidate must have strong experience in all aspects of instrument management in a GMP environment, in addition to an understanding of the needs and best practices of routine biopharmaceutical drug product and drug substance laboratories. They will have responsibility for establishment of project plans and instrument qualification procedures. Experience in Data Integrity management (21 CFR 11/EU Annex 11) is desired. A strong fundamental understanding of protein biochemistry is desirable, in addition to technical expertise in the following Biopharmaceutical analytical platforms (HPLC/UPLC, CE, cIEF, SDS-PAGE, Biacore, HIAC, KF, Liquid Handlers). The main responsibilities for this position include; • Providing a Calibration and/or Maintenance Service to the QC laboratory that includes instrumentation calibrations, scheduling and tracking of instrument maintenance and instrument lifecycle management. • Review and approve analytical instrumentation qualification, calibration, repairs and documentation. • Ensure instrument maintenance and verification is appropriate to the use of the instrument • Manage all instrument specific investigations such as calibration deviations • Trend lab instrument performance and lifecycle management. • Participate in new instrument purchase and qualification • Participate as part of a team of QC Specialists, QA validation Specialists and Computer System Validation personnel to deliver on the qualification of new instruments. • Liaise with sister sites and vendors on instrumentation purchase, qualification and lifecycle management. • Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, calibration and lifecycle management. • Participate in definition and establishment of instrument related procedures. • Participate in troubleshooting complex instrumentation issues. Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs. Qualifications, Knowledge and Skills Required: * The ideal candidate should hold a minimum of a B.Sc. in scientific related discipline and must have at least 3 year’s experience, at least 1 of which should be related to instrument qualification experience in a GMP laboratory setting. Previous experience in technology transfers would be advantageous. * The successful candidate must demonstrate the ability to...