Process Engineer II

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Job Purpose / Position Summary

Bristol Myers S is developing novel cellular immunotherapies based on two distinct and complementary platforms - Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer.

We are looking for a Process Engineer to join the External team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department. The successful candidate will collaborate with the GMSAT teams in Seattle and New Jersey locations in the US and support efforts related to the tech transfer of cell therapy manufacturing technologies to external CMO's. The Process Engineer will be responsible for the implementation of technologies, including cross-departmental collaboration to enable facility fit, development of process documentation (Batch Records, Forms, etc), e-systems deployment, inspection readiness, and training. This engineer will have responsibilities like an internal MSAT organization for BMS's cell therapy drug product manufacturing site with the focus on supplementing the technical capabilities of the CMO. This person will provide support to the Tech Transfer Lead and will support processes from early clinical phase through PPQ and commercial manufacturing support. The Process Engineer will support product lifecycle management, including commercialization and evolution of cell therapy products as well as day to day operations technical support at CMOs to ensure reliable quality supply. The role will be highly cross-functional and will interact with other CTDO/GPDO groups and in-country affiliates in establishing manufacturing and technology capability, CMO selection, facility fit and design, equipment selection, and facility start up work force training.

Responsibilities include, but are not limited to, the following:

• Support process and technology transfers, change management, and provide technical process support for routine clinical and/or commercial cell therapy products at the CMO.
• Implement and support the execution of process control strategies including execution of process risk assessments, and continued process verification.
• Support production related investigations, ensuring compliance with internal standards and regulatory requirements
• Perform monitoring of manufacturing processes to understand process capability.
• Develop, understand, and manage tools and templates that can be used to quantify impact and criticality for parameters and attributes within the organization and/or CMO unit operations
• Support design activities for clinical and/or commercial facilities
• Leverage and maintain strong relationships with external partners
• Support product implementations in coordination with Development, Manufacturing, and Quality groups, including visits to contract manufacturing sites
• Support permanent inspection readiness and actively support regulatory inspections
• Ensure manufacturing processes are in a state of control, harmonized across the cell therapy manufacturing network
• Develop, execute manufacturing process improvement activities in accordance with the overall life cycle plan for the product
• Share operational and process learning with the rest of the manufacturing network
• Provide necessary technical analysis to enable decisions related to new raw materials or selection of CMOs

Skills/Knowledge Required:

• B.S. with 2-4 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline
• Experience with cellular therapies is strongly preferred
• Extensive experience in a regulated manufacturing environment
• Flexibility to work within manufacturing schedules
• Familiarity with literature on process development and cell therapy
• Ability to assess risk and develop contingency plans for process risks
• Excellent communication, writing, organizational, teamwork, and presentation skills
• Strong interpersonal and leadership skills to work with teams in different functions and organizations

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.