Sr. Specialist, Manufacturing Systems Engineering & Operations, Site Labeling Operations

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.

The Sr. Specialist of Manufacturing Science and Technology (MSAT) Manufacturing Systems Engineering and Operations (MSEO) - Labeling Operations brings enthusiasm, intellectual curiosity, scientific rigor, technical knowledge, and a desire to help drive novel programs to lead activities supporting labeling systems and operations for the Summit West Manufacturing Cell Therapy site. 

The Sr. Specialist is an individual contributor responsible for supporting the labeling operations intake and design, development, delivery, validation, operational support, continuous improvement, change management, and lifecycle for the site manufacturing execution system (MES) and associated boundary systems used in the labeling and packaging of personalized cell therapy products for both global clinical trials and commercial supply. This individual must be independent, goal-oriented, flexible, able to work efficiently across multiple projects, enthusiastic, and innovative, with a good understanding of good manufacturing practices and technologies to support the needs of the Site Manufacturing Teams. 

Key Responsibilities:

• Support projects and initiatives 
• Execute site strategic and tactical label lifecycle management 
• Ensures assurance of supply and compliance to content for new product markets and indications launches, safety updates, and other core packaging and labeling materials programs or initiatives 
• Supports new product markets and indications launches 
• Provide technical direction and expertise across Site teams 
• Support/Lead site in-process labeling materials artwork strategy 
• Support network (shared) packaging and labeling materials artwork strategy 
• Support/Lead the execution of QMS deliverables -   including creation/revision of documentation Change Controls, CAPAs, technical reports, etc.  
• Ensure delivery of labeling design and content in compliance with BMS policies, practices, Global Regulatory, cGMP requirements 
• Ensure the Cell Therapy Operations organization meets its performance objectives through delivery and operational support  
• Support the planning and execution of assigned label focused projects, launches, site transfers, country/area specific changes, issue resolution both strategically and tactically  
• Responsible for creating, coordinating, ensuring accuracy, and realizing label changes and associated deliverables in the Manufacturing Execution System and boundary systems 
• Support the periodic review process of label management policies and procedures. 
• Monitor performance metrics for label change management and operations. 
• Support network shared packaging and labeling materials strategy development and maintenance over the product life cycle  
• Change Plan ownership for labeling operations 
• Support on-time and consistent execution of MES label modifications, change controls, and adherence to governing documents related to change management. 
• Provide best effort on-floor, on-site, or remote level 2/3 support to site operations teams (manufacturing, quality, supply chain, IT).  
• Support the execution of Manufacturing Systems incident resolution, quality event investigations, and impact assessment development on the labeling specifications, policies and procedures, and associated elements. 
• Effectively collaborate across th