Senior Manager, Stability, Global Product Quality, Cell Therapy (R1550412-en-us-1)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Senior Manager - Stability, Global Product Quality
The Stability Senior Manager, 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 Stability Senior Manager will be responsible for all aspects of stability program management including but not limited to protocol design, data organization, reports and work collaboratively with teammates in Quality, Manufacturing, Supply Chain, and the project teams for externally managed studies.
The primary focus of the role will be to support cell therapy stability program from clinical development through commercialization by providing quality oversight and management of cell banks, plasmids, vectors, drug product intermediates, drug products and drug product stability studies. May provide additional support of contract manufacturing organizations (CMO) virtual plant teams.
- Support stability strategy and implementation for Global Product Quality across teams and processes.
- Lead and manage all aspects of stability program across multiple projects, including initiating and managing stability studies, protocol development, data monitoring, trending, and reporting.
- Collaborate with project teams to assess stability commitments, sampling and testing requirements, and stability specifications as applicable.
- Author, review and Approve protocols and reports for Cell Banks, Plasmids, Vectors and Drug Product stability.
- Maintain stability database including sample pull, testing and data reporting schedule
- Support regulatory submissions and response to questions from healthy authorities
- Ensure any stability issues or potential issues are communicated to the appropriate stakeholders.
- Actively participate in stability related deviations, investigations and/or CAPA
- Support operations functions associated with
- Manage change controls and GPQ owned records through document and/or quality management system(s).
- Specification management (upstream, vector, DP intermediates, and DP), change control ownership and implementation globally
- Support all early development and late development / commercial activities as needed.
- Other duties as assigned
- 7-10 years of experience in a GMP manufacturing setting with a strong focus on stability program management.
- Scientific background in analytical methods and stability
- Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological, cell therapy, or small molecule products.
- Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
- Strong written, verbal, and organizational skills, and ability to work in inter-disciplinary and cross-functional teams.
- Strong attention to detail and organization skills.
- Background in plasmid manufacturing, mammalian cell banking, DNA sequencing methods, or cell therapy.
- Experience with eQMS, CelDox, and general Quality systems
- Experience working with external suppliers: CMOs/CROs/CTLs/CSPs
- Bachelor's or Master's Degree in a relevant scientific discipline
Primary Work Location: Summit NJ or Seattle, WA
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
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.
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