Senior Specialist, Quality Control Analytical Testing

Benefits

Additional Information

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 . PURPOSE AND SCOPE OF POSITION: The QC Senior Scientist is responsible for supporting the analytical testing at QC Analytical Testing department at the CAR T manufacturing facility during clinical and commercial phases. This department is responsible for flow-cytometry and molecular based testing for stability, validation, critical reagent qualification, training, and other critical support as needed. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. This is Wed-Sat day shift. REQUIRED COMPETENCIES (Knowledge, Skills, and Abilities): Advanced hands-on experience with various analytical techniques including flow-cytometry, molecular techniques and scientific knowledge in the characterization and transfer of pharmaceutical products. Advanced ability to accurately understand, follow, interpret, and apply Global Regulatory and cGMP requirements . Advanced technical writing skill s, problem - solving ability/mentality, technically adept and logical thinking. Ability to represent the interests of the gro u p on cross - functional team s . Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Ability to work with management locally and globall y . Advanced a bi li t y to communicate effectively with peers, department management and cros s -functional peer s . EDUCATION AND EXPERIENCE: Bachelor's degree or equivalent required, preferably in science. Advanced Degree preferred. 2-4 y e ars o f relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment. Experience working with sterile cell culture, polychromatic flow-cytometry panels, flow-cytometry data analysis, ELISA, and qPCR preferred. DUTIES AND RESPONSIBILITIES: Perform testing of the QC Analytical Testing Department including: Utilize scientific principles to assist in anal y tical testing methods and the proper use of laborato r y equipment. Perform cell based in-vitro flow experiment, ELISA, qPCR to assess critical regent concentration. Capable of handling complex issues and solving problems with only general guidance. Prepare and present continuous improvement projects to management. Comprehensive understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents. Complete all work in a timely manner. Perform peer review of testing data. Review all data in accordance with applicable procedures and cGMP requirements. Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner. Complete all reviews in accordance with required release timelines. Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required. Support document revision, project, CAPA, and investigation/deviation tasks. Perform assigned tasks within a CAPA, deviation, or project Participate in complex projects and continuous improvement efforts. Take a leadership role, as required, for projects. Draft and review technical documents, such as SOPs and protocols/reports. Communicate effectively with management regarding task completion, roadblocks, and needs. Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles. Performs other tasks as assigned. WORKING CONDITIONS (US Only): The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required. The incumbent must analyze numerical values on a daily basis. The incumbent will be working a laboratory setting up to six ( 6) hours per day. The incumbent will be working around bio hazardous materials, including chemical agents up to six ( 6) hours per day. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are inte