Associate Scientist

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. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Associate Scientist/Engineer is responsible for leading investigation reports in support of S12 CAR T operations. This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and troubleshooting complex problems. The successful incumbent must interface closely with different functional organizations, including Quality Assurance teams. Shift Available: * Monday - Friday, Hybrid Day Shift, 9 a.m. - 5 p.m. *Based on business needs potential extended hours during off shift or weekend. Responsibilities: * Conduct thorough investigations (Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools. * Lead investigations and cross functional investigation teams, and close reports in a timely manner * Perform GEMBA walks with stakeholders to better understand process steps and evaluate Root Cause Analysis. * Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness. * Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy. * May Initiate change control documentation * Identify functional area SMEs to perform impact assessments as part of the change management process. * Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner. * Provide technical support for manufacturing investigations / CAPAs / Change Controls as needed. * Support deviation investigation defense during audits and site inspections related inquiries. * Handle complex issues and solve problems with minimal guidance. * Serve as author or technical reviewer of departmental procedures as appropriate. * Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems. * Continuously support S12, living the “patients first” mission and fostering a “Right First Time” mindset. Knowledge & Skills: * Working experience of deviation investigations utilizing root cause analysis tools. * Working experience in the CAPA process and ability to identify and verify effectiveness. * Technical writing skills and ability to collaborate effectively in cross functional teams. * Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements. * Ability to support health authority inspections. * Knowledge of data trending and...