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 .

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.

This role is responsible for leading the Material Review Board (MRB) and the Disposition groups at the Summit Cell Therapy S12 site. Responsibilities include but not are not limited to the oversight of the cross functional Material Review Board meetings at S-12 ensuring all related actions and follow ups to the meetings are completed timely. The incumbent will be responsible for all quality activities associated with the final disposition / release of product as well as improving and maintaining systems related to lot release needs, communicating those needs, and driving organizational changes to improve time to release.

Shift Available:

• Monday - Friday, Hybrid role

Responsibilities:

• Accountable for the effective and efficient execution of the MRB and disposition processes in full compliance with all internal and external regulatory requirements.

• Sets the mission, strategy, goals, objectives, and KPIs for the teams.

• Ensuring teams remain flexible and agile to respond to changing business needs by promoting cross-training between teams.

• Assures standard operating procedures (SOPs) related to the team’s job responsibilities define the steps necessary to complete tasks in an efficient and compliant manner.

• Accountable for any global, regulatory, or corporate inquiries related to the MRB and disposition processes.

• Supports site and functional teams during regulatory inspections or audits, which may include direct interaction with inspectors/auditors as well as writing and/or reviewing responses.

• ​Manages departmental operational expenses in alignment with allocated budget.

• Strong supporter of Culture of Excellence across CTDO and adherence to BMS core behaviors.

• Provide leadership and support for systems project teams, site initiatives, and committees to ensure that all system issues and opportunities are addressed in a timely, effective, and First-Time manner.

Knowledge & Skills:

• Understanding of technical areas related to pharmaceutical, biological, and/or cell therapy manufacturing, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes, validation and qualification requirements, etc.

• The position requires strong capabilities associated with organizing workload and tracking progress of multiple deliverables tied to multiple batches pending release simultaneously.

• Experience leading continuous improvement and operational excellence transformations within Quality Operations.

• Demonstrated Quality leadership and a partnership approach with Operations to enable high-quality and compliant product distribution to patients.

• Experience managing regulatory audits or regulatory inquiries.

• Must have a thorough understanding and practical application of domestic (FDA) and international (e.g., EMA, PMDA) Good Manufacturing Practices for drug products and biologics.

• Demonstrated influential leadership expertise and experience with senior and mid-level management. Ability to partner and influence site leadership functional areas inside and outside of Quality Operations.

• Demonstrated enterprise mindset with an ability to think and act across functions and divisions.

• Demonstrated ability to work in an organization with a range of technically, culturally, and geographically diverse teams, to influence areas not under direct control to achieve objectives, and to effectively communicate challenging goals and objectives.

• Demonstrated strong leadership capability with the ability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results that meet high-quality requirements with tight deadlines.

• Demonstrated agility in anticipating and leading others through change and ambiguity.

• Ability to provide innovative ideas or alternatives that create value, including seeking new information and external insights without compromising compliance.

• Excellent teamwork, interpersonal, and communication skills, with the ability to establish direction, create an atmosphere of trust, and build relationships within the group and between the group and its suppliers and customers.

• Must be skilled in managing direct and indirect reports as well as planning and organizing group activities and priorities. Able to create pragmatic solutions with limited resources.

• Highly contributes to departmental performance and Quality initiatives.

• Can effectively communicate simple and complex issues in written format or in person through face-to-face or virtual (MS Teams) environments.

• Proficient in MS Office software applications and able to develop materials within MS Office to aid in effective communication.

Basic Requirements:

• Bachelor’s degree required, preferably in chemistry, microbiology, pharmacy, or related science.

• Minimum of 10 years of proven experience in quality operations within the pharmaceutical/biological or cell therapy industries.

• Minimum of 7 years of experience with project management.

• Minimum of 7 years of experience with being Manager of Managers (tiered leadership).

Preferred Requirements:

• Advanced degree, preferably in chemistry, microbiology, pharmacy, or related science.

• Experience within a Quality role.

• Health authority experience.

• cGMP experience.

#BMSCART, #LI-Hybrid

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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.

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

Company: Bristol-Myers Squibb

Req Number: R1580665

Updated: 2024-05-04 01:22:13.759 UTC

Location: Summit-NJ

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.