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Sr. Scientist/Sr. Engineer, Cryogenics and Transportation Science, Global MS&T Capabilities

This position of Sr. Scientist/Sr. Engineer is based in Devens, MA, and serves a global network support role for drug substance packaging/shipping in Cryogenics and Transportation Science group in the Global Product Development and Supply organization.
Responsibilities
+ Serve as a technical lead and subject matter expert for cryogenics and transportation processes of commercial and late stage biologics drug substance across BMS global network and contract storage/manufacturing sites.
+ Select, develop, and implement packaging concepts and technologies for new and existing products with specific focus on packaging systems for active and passive cold chain distribution.
+ Collaborate with third parties for planning/execution of outsourced shipping studies. Design and execute shipping validation studies (DQ/OQ/PQ) for transportation of bulk drug substance and analytical samples across global sites. These studies will include conducting risk assessment(s), authoring study protocols, executing shipments, compiling and analyzing data, and authoring technical report(s). Appropriate GLP/GMP procedures must be followed
+ Collaborate with global functions such as global packaging, global logistics, supply chain, manufacturing, and quality assurance to continuously improve and harmonize the cold-chain processes at BMS.
+ Support cryogenics and transportation related site investigations, impact assessments, change controls, and health authority inspections.
+ Keep up with industry standards and best practices by periodic review of guidance documents and participation in forums such as BPOG
Qualifications
+ BS, MS, or PhD degree in Packaging Engineering, Pharmaceutical Sciences, Biological or Chemical Sciences/Engineering, or related disciplines. BS with 13 or more years of applicable experience, MS with 10 or more years of applicable experience, or PhD with 4 or more years of experience. Advance degree is preferred.
+ Demonstration of expertize in heat transfer fundamentals is required. Knowledge of shipping qualification, transportation and packaging design is desired.
+ Knowledge of protein dynamics and stability, especially the effects of freezing and thawing on protein stability, is desired.
+ Knowledge of common protein analytical tools and demonstrated experimental skills for lab work is required.
+ Excellent verbal & written communications skills, interpersonal and facilitation skills to interface with and influence all levels of the organization, and ability to lead people and multi-disciplinary teams are desired.
+ Experience with cGMP regulations, regulatory requirements, CMC authoring for biologics processes, and health agency inspections are a plus.
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, disability or protected veteran status.


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