Senior Specialist, Label and Business 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 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.

The Senior Specialist, Label and Business Operations, is responsible for managing and executing the end-to-end product labeling process at our multi-product Clinical Manufacturing Facility in Warren, NJ. Additionally, this position will lead and execute the implementation of cross-functional projects and initiatives from the Strategy and Business Operations functional area. The ideal candidate will have the proven ability to lead projects with team members across various functions to achieve results, to manage complex data sets tracking metrics and project status, to build trust and a positive working environment within work teams, to be highly detail-oriented in sensitive GMP operations, and to work effectively under minimal supervision.

Key Responsibilities:

• Manage and execute the full product labeling process, including printing, issuance, Chain of Identity (COI) verification, and reconciliation of finished drug product labels used by Manufacturing and Supply Chain Operations. 
• Ensure completeness, accuracy, and control of changes in labeling  including maintenance of labeling related specifications, templates, work instructions, and documentation associated with these specifications.
• Seamlessly interface with the operations schedule, compliance with content requirements and timely implementation according to BMS templates and work instructions, and consistently deliver on-time accurate product labels for production use. 
• Author deviations, change controls, actions, SOPs, work instructions, templates, and other records as necessary to support the Labeling and Business Operations department.
• Collaborate with key stakeholders in global or local change processes to evaluate impact of changes on labeling processes or systems, and provide and implement solutions to maintain efficiency and compliance.
• Manage automated processes related to data transfer and data management, and take ownership of change efforts to automated label processes.
• Authors effective procedures and job aids for new programs and change requirements.
• Lead execution of continuous improvement and operational excellence projects with impact across multiple functions utilizing effective communication, problem-solving, and appropriate escalation.
• Support execution of site operations plans, supply strategies, and technology transfers into the site with cross-functional teams to meet clinical program needs and ensure timely product delivery to patients.
• Collaborate with other functional teams on system implementations and continuous improvement projects.
• Support and lead, as needed, Site Master Schedule review meetings to drive execution and monitor site KPI metrics in coordination with activities of apheresis/PBMC receipt, material kitting, process intermediates, manufacturing, and drug product shipments.
• Identify and implement policies, procedures, risk assessments, and manufacturing strategies to optimize production and performance.
• Actively builds trust, collaboration, and a positive working environment in cross-functional work teams.
• Promote a culture of collaboration, continuous improvement, and alignment across various functions and departments to achieve major site strategic manufacturing objectives.
• Prioritize and complete work with a sense of urgency based on criticality.
• Demonstrate highly effective written and verbal communication.
• Ability to work independently and lead a large cross-functional group. 
• This position will report to the Sr. Manager, Strategy and Business Operations.​
• Travel: This position requires up to 10% of travel

Specific Knowledge, Skills, Abilities:

• Knowledgeable on cGMP/Pharmaceutical regulations, cell culture, cryopreservation, purification, and aseptic processing lab technique and ERP systems and analytical tools.
• Experience with authoring deviations, change controls, actions, SOPs, and work instructions. 
• A demonstrated ability to collaboratively lead large cross-functional teams. 
• A demonstrated ability to perform highly detail-oriented tasks with compliance to GMP quality standards.  Proficient in MS Office applications, written and verbal communication skills and presentation development and delivery skills.
• Strong technical writing capability.
• Able to work independently for extended periods of time, solve routine and complex problems with minimum management support, manage complex data sets, able to provide on-call support in case of emergent issues.

Education/Experience/ Licenses/Certifications:

• Bachelor’s degree required. 5+ years of relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment.

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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.

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 an inclusive culture, promoting diversity 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 a diverse 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.

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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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/

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