Specialist, Label Operations

Specialist, Label Operations

Summit West - NJ - US

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.

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.

Specialist, Label Operations at the S12 Cell Therapy manufacturing facility is responsible for supporting site Label Control activities at S12 in accordance with BMS policies, standards, procedures and Global cGMPs. Functional responsibilities include performing in-process and drug product label printing activities, ensuring accurate and timely issuance of labels for manufacturing and packaging labeling activities for Cell Therapy Development and Operations (CTDO).

Shift Available:

• Sunday - Wednesday (with e/o Wednesday off), 2nd Shift, 6:00pm-6:30am.

Responsibilities:

· Supports all activities for the Label Operations group.

· Responsible for issuing clinical and commercial in-process and final product labels for labeling operations.

· Responsible for ensuring accurate printed information on labels in compliance with health authority requirements.

· Coordinates with production teams to ensure timely issuance of labels.

· Performs training of label operations and issuance requirements for internal personnel as needed.

· Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs as required.

· Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned.

· Provides support during internal and health authority inspections and audits of facility.

· Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management.

· Performs supplemental investigations/projects as required by Management.

· Maintains knowledge of current GMPs and regulatory guidelines.

Knowledge & Skills:

· Preferred knowledge and experience with GMP, Quality, and compliance.

· Able to write and review technical reports with clarity and brevity; provides guidance to other team members in technical writing skills.

· Must have knowledge and experience with GMP, Quality, and compliance.

· Able to write and review technical reports with clarity and brevity; provides guidance to other team members in technical writing skills.

· Requires moderate direction to complete more complex tasks; completes routing tasks with little or no supervision.

· Must be time organized and possess an independent mindset.

· Good understanding of electronic document management and manufacturing execution systems.

· Has advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.

· Confident in making decisions for non-routine issues.

· Routinely recognizes and addresses quality opportunities to improve overall process/project efficiencies.

· Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.

· Builds relationships and effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams.

· Contributes to goals within the work group.

· Able to recognize conflict and notify management with proposed recommendations for resolution.

· Able to prepare written communications and communicate problems to management with clarity and accuracy.

· Able to produce data reports with precision.

· Able to muti-task.

· Able to support internal and health authority inspections of facility

Minimum Requirements:

· B.S. Degree required, minimum 2 years relevant work experience.

· Equivalent combination of education and experience is acceptable.

Working Conditions: (If applicable)

• Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
• Required to carry and/or lift up to 30 pounds / 15 kg, several times a day, while handling production equipment and/or materials.
• Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays).
• Employees holding this position will be required to perform any other job-related duties as requested by management.

Compensation Overview:

Summit West - NJ - US: $34.92 - $42.32per hour

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

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: T he 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