Associate Director, Stability, Global Product Quality

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

Associate Director, Stability, and Global Product Quality will be a member of the Global Product Quality (GPQ) Department. GPQ supports the development and commercialization of cell therapy products through representation on virtual plant teams, oversight of product testing, and external manufacturing. The Associate Director, Stability will work collaboratively with Product Quality Lead, Manufacturing, Supply Chain, and project teams with external manufacturing needs.

The role’s primary focus will be to support cell therapy stability programs from clinical development through commercialization by providing quality oversight and stability program management of cell banks, plasmids, vectors, drug product intermediates, and drug products.

Responsibilities:

• Design and coordinates stability strategy implementation for multiple products and programs for developmental and commercial products.

• Lead a high-performing team to align stability strategy for each program, including cell bank, plasmid, vector, intermediates, and drug product.

• Manage ongoing internally or externally executed stability studies for all commercial and development and support additional stability studies as part of life cycle management.

• Manage internal and external stability programs, including review of stability protocols, reports, data trending, regulatory filings and APQR

• Collaborate with Product Quality Lead, Analytical Science, QC, Manufacturing, CMC, and External manufacturing and supply chain.

• Provide quality oversight for end-to-end stability program management, including study initiation, sample pull, and testing, data collection from internal/external labs, data trending, report generation, OOS/OOT investigations, Deviations, or quality events.

• Support preparation of relevant CMC sections and response to questions from healthy authorities

• Support Quality functions associated with Change controls, Deviation management, and Specification documents

• Other duties as assigned

Skills/ Knowledge:

• Effective written, verbal, and organizational skills

• Ability to work in inter-disciplinary and cross-functional teams

• Ability to work in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.

Basic Qualifications:

• BS in a scientific discipline

• 10+ years of experience supporting or managing stability programs

• Proven scientific background in analytical methods, stability studies

• Experience with statistical analysis tool such as JMP

• Experience managing and leading a high-performing team.

• Demonstrated understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological, cell therapy, or small molecule products.

Preferred Qualification:

• MS in a scientific discipline

• Background in biologics or cell therapy product development.

• Experience with Veeva, eDMS, and general Quality systems

• Experience working with external suppliers: CMOs/CROs/CTLs/CSPs

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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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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.

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

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