Manager, Label Operations

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.

This is work that transforms the lives of patients, and the careers of those who do it. At Bristol Myers Squibble 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 Label Operations Manager at the S12 Cell Therapy manufacturing facility is responsible for implementing and managing the site Label Operations activities at S12 Summit West (Summit, NJ) in accordance with BMS policies, standards, procedures and Global cGMPs. Functional responsibilities include supervision of all label control activities for Cell Therapy Development and Operations (CTDO);
Responsible for developing and maintaining a GMP compliant clinical and commercial label issuance and control process.

Shift Available:
Wednesday - Saturday (with e/o Wednesday off), Onsite Night Shift, 6 p.m.

- 6:30 a.m.

• The Label Operations manager will lead team to ensure Label Management and align with Global and Regional Regulatory requirements.
• Manage and motivate team members, build trust and cultivate a collaborative environment.
• Oversee team responsibilities and maintain a state of compliance.
• Work proactively to identify and address any label control compliance issues.
• Oversees, supervises, coordinates and prioritizes daily activities of the Label Operations team located at Summit, NJ S12 facility.
• Act as site lead for clinical and commercial label management related system implementation initiatives.
• Fully support projects within project timelines.
• Assures job objectives are met on a timely basis.
• Assures timely issuance of clinical and commercial in-process and final product labels for labeling operations.
• Coordinates and prioritizes project deliverables to support new drug product launches, new market and other quality management activities as assigned.
• Creates employee development plans, and oversight of functional area to assure adequate staffing.
• Coach and mentor subordinates in the areas of training, disciplinary action, problem solving, and professional growth.
• Provide support for activities using the electronic label issuance and control systems.
• Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc.
• Writes, reviews and updates SOPs while managing archival of batch records and GMP documentation for the site.
• Perform gap assessments to identify process deficiencies, provide reports to document detailed findings and recommend potential solutions.
• Develops and maintains quality metrics to monitor compliance.
• Collaborates with stakeholders to develop appropriate actions to resolve quality system issues.
• Responsible for developing, managing, and on-boarding requirement for new staff within label control.
• Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.
• Performs supplemental investigations/projects as required by management.

• Must have advanced…