Engineer I, CAR-T Clinical Manufacturing Sciences & Technology

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 rich in diversity. 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.

Title: Engineer I, CAR-T Clinical Manufacturing Sciences & Technology

Location: Warren, NJ

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 Engineer I, CAR-T Clinical Manufacturing Sciences & Technology is responsible for supporting the production of personalized cell therapy products for global clinical trials. Collaborates with SMEs from the Development Group, Global MSAT Group, Supply Chain Group, Manufacturing Group, and Quality Group while providing technical support for the resolution of process deviations, the evaluation and implementation of process changes and continuous improvement support to the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

Qualifications & Experience:

• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities

• Bachelor’s Degree in science or engineering (advanced degree is preferred)

• 5 or more years of manufacturing support or related experience in the biopharmaceutical industry

• Intermediate knowledge of cGMP’s and multi-national biopharmaceutical/cell therapy regulations

• Intermediate knowledge of facility/clean room design, process, equipment, automation, and validation

• Beginner knowledge of Delta V and OSI Pi

• Intermediate strong verbal/written communication skills and ability to influence at all levels

• Intermediate ability to think strategically and to translate strategy into actions

• Intermediate ability to prioritize and provide clear direction to team members in a highly dynamic environment

• Intermediate knowledge of quality by design and risk management

• Intermediate experience with Operational Excellence and Lean Manufacturing

Key Responsibilities:

Ensure safe and compliant cGMP operations

• Maintain permanent inspection readiness and actively support regulatory inspections.

• Interface with regulatory authorities as required to support Manufacturing Operations audits.

• Foster a culture of compliance and strong environmental, health, and safety performance.

• Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.

• Provide technical input and investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements

• Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs)

• Sponsor and support the change initiatives and the implementation of process improvement initiatives

Support Clinical Production Activities

• Support production related investigations, ensuring compliance with internal standards and regulatory requirements.

• Continuously monitor, anticipate and permanently resolve issues that may arise during production.

• Interface with operators and serve as process SME. Learn the procedures, analytics and document any known