Scientist I

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.

PREREQUISITES

B.S. degree in immunology, cell biology, molecular biology or equivalent field with a minimum of 6-8 years of experience, or M.S. degree with a minimum of 4-6 years of experience, or Ph.D. level in related discipline with 0-2 years of experience in biopharmaceutical industry developing and optimizing cell-based and immunoassay methods. Working with immunoassays and cell-based in-vitro assays using primary cells and

engineered cell lines are required. Experience with cell line engineering and flow cytometry are highly desirable. The position level will be dependent on experience.

Position Description:

The Biologics Development group at Summit west has an exciting opportunity for an experienced bioassay scientist to join our team. It carries responsibility for developing and implementing phase-appropriate cell-based and binding assay methods to support the release, stability, and biological characterization of BMS portfolio of biological therapeutics. Work independently with minimal supervision.

Responsibilities will include, but are not limited to, the following:

• Design, develop, optimize, phase-appropriately validate, and transfer potency methods to internal and external QC testing labs
• Develop, qualify, and support sample testing for characterization bioassays, primary cell killing assays and binding assays to contribute to the understanding of therapeutic critical quality attributes and degradation pathways.
• Generation and characterization of stable immortalized cells and cell line engineering.
• Evaluate and implement new technologies and instrumentation (e.g., automation) to support operational efficiency and improved sample throughput.
• Support in-process and GMP sample testing, coordination of sample management, and report results in a GMP or a non-GMP testing sample database.
• Review and release sample testing results per method SOP
• Monitor and evaluate method performance with assay trending tools
• Author and review scientific documents, such as method SOPs, development reports, qualification and technical reports.

Skills/Knowledge Required:

• Experienced in the development and optimization of cell-based assays and binding assays.
• Experienced in working with cultured cells, primary cells, and cell line characterization.
• Experience in developing immunoassays such as ELISA.
• Methodical and committed to high-quality results
• Knowledge or experience with SPR, BLI, or other binding assay methodologies.
• Knowledge or experience with flow cytometry
• Knowledge or experience with cell line engineering using lentiviral methods
• Experience using data analysis software such as Excel, Prism, JMP, SoftMax Pro, PLA, FlowJo, etc.
• Prior cGMP/GLP training and experience working in a cGMP/GLP environment required
• Strong scientific, interpersonal and communication skills (written and oral)
• Must be able to work in a team environment and perform corresponding job responsibilities under minimal supervision
• Experienced with writing/reviewing scientific documents.
• Knowledge of FDA, EMEA and ICH guidelines desirable but not required.

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.