Manager, Senior Process Engineer I

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.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

The Manager, Senior Process Engineer I is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. Serves as process SME. Collaborates with SME from the Development 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.

Responsibilities:

• Participate on project teams to prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management
• Run internal projects (e.g. Project initiation, planning, scope, funding requests, approvals, execution and closeout)
• Work closely with Engineering /Maintenance on the design and implementation of new technology and new systems/facilities related to production process needs
• Interface with operations and serve as process SME. Learn the procedures, analytics and document any known sensitivity.
• Support monitoring, analyzing, and optimizing the end-to-end process and anticipate and permanently resolve issues that may arise during production
• Support inspection readiness and actively support regulatory inspections and ensure safe and compliant cGMP operations
• Review and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records)
• Interact with other teams including Validation, Development, Operations, QA and Regulatory
• Support Director in accomplishing productivity and financial goals with the cross-functional team
• Participate in routine plant operating meetings

Knowledge & Skills:

• Knowledge of cGMP’s and multi-national biopharmaceutical regulations. Cell therapy experience is a major plus
• Deep knowledge of facility/clean room design, process, equipment, automation, and validation
• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
• Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies
• Experience working with external parties and/or leading cross-functional teams
• Possess strong verbal/written communication skills and ability to influence at all levels
• Ability to think strategically and to translate strategy into actions
• Ability to prioritize and provide clear direction to team members in a highly dynamic environment

Preferred Requirements:

• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
• Bachelor’s Degree in science or engineering (advanced degree is preferred)
• 3 or more years of manufacturing support or related experience in the biopharmaceutical industry

 
Working Conditions:

• The incumbent will be working 60% to 75% of the time in an office environment.
• The incumbent will be working 25% to 40% of the time in a manufacturing and/or laboratory setting.
• The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
• The incumbent will need to have flexibility to work extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines.

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