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 the organization at a global and local level to support business strategies, best practice operations, and Business Continuity (BCP).  
• Lead the execution of QMS deliverables -   including creation/revision of documentation (i.e., specification documents, standard operation procedures, work practices, training, etc.), Change Controls, Change Actions, CAPAs, technical reports, etc.

Qualifications & Experience:

• Bachelor’s degree required in Engineering, Biological/Life Sciences, Business (Supply Chain), or related field, or equivalent combination of education and work experience.
• Minimum of 4+ years of relevant work experience required in the biotechnology/pharmaceutical or related industry.
• Cell Therapy experience preferred.
• Experience working effectively across different cultures, multiple functional areas and in complex matrix environments.
• Excellent written and oral communication skills with all levels of management and personnel.
• Demonstrated success in negotiating and problem-solving skills.
• Strong interpersonal and organizational skills.
• Excellent leadership skills and a proven ability to drive cross functional collaboration.
• Understands Regulatory, Quality and Supply Chain aspects of labeling and impact of non-compliance.
• Knowledge of applicable regulations and standards affecting Cell Therapy products, specifically regulations and standards affecting the Packaging and Labeling Quality System.

#LI-Onsite

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Summit West - NJ - US: $88,026 - $106,667

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
 

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

​Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)

• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1600294 : Sr. Specialist, Manufacturing Systems Engineering & Operations, Site Labeling Operations