Scientist II

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

PREREQUISITES

B.S. degree in a scientific discipline with a minimum of 8 years of experience, M.S. degree

with a minimum of 6 years of experience or Ph.D. level in related discipline with a minimum of 2-4 years of experience in the Biopharmaceutical industry developing and optimizing cell-based and immunoassay methods. Experience with mammalian cell culture and cell line development are required. Working with primary cells and flow cytometry are also desirable. 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 establishing 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

Experienced with writing/reviewing scientific documents.

Knowledge of FDA, EMEA and ICH guidelines desirable but not 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


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 the resources to pursue their goals, both at work and in their personal lives.

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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