Senior Scientist, Potency Assay Development

Employment Type

: Full-Time

Industry

: Miscellaneous




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.

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.

PURPOSE AND SCOPE OF POSITION:

Bristol Myers Squibb is seeking a Senior Scientist with a passion and drive to join our team in the fight against cancer. The successful candidate will join the interdisciplinary Product Potency and Function department within Product and Analytical Development. This role will be responsible for developing analytical methods that characterize novel autologous and allogenic cell therapies undergoing clinical trials, including CAR T cell products. The successful candidate will lead a team of three or more individuals who are responsible for evaluating technology platforms, developing robust analytical methods, expanding product understanding, and providing analytical support to studies that refine the manufacturing processes to improve product quality.

The Senior Scientist will lead individuals who are developing methods that assess antigen-specific function of cell therapies through gene upregulation, proliferation, cytokine secretion, and cytolytic activity. In addition, the Senior Scientist will oversee individuals who are developing methods that evaluate cell viability, cell metabolism, and cell health for informing media development, process development, and formulation studies. The successful candidate will have hands-on experience with developing these assays, demonstrated project leadership experience, a passion for mentoring, and enjoy working on projects requiring close collaboration with groups such as discovery research, product sciences, process development, and QC. The successful candidate will be enthusiastic about developing novel medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of likeminded Scientists.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education:

PhD in Immunology, Cancer Biology, or relevant discipline

Experience

Qualifications and Education Requirements
  • 5+ years of relevant experience
  • Expert knowledge in discipline; characterizing antigen-specific T cell function, cell viability, cell health, and metabolic activity.
  • Passion for mentoring
  • Experienced in assessing technology platforms
  • Proficient at developing robust analytical methods and authoring test methods, protocols, and technical reports
  • Demonstrated experience leading projects, teams, and collaborations
  • Good documentation skills
  • Outstanding written and oral communication skills


Preferred Qualifications
  • Expertise with live-cell imaging ( e.g. IncuCyte), fluorescent imaging, flow cytometry ( e.g. intracellular cytokine signaling, CFSE, metabolic assays, etc .), and quantification of secreted cytokines by MSD and AlphaLISA; experience with Luminex, ELLA, and ELISA is also desirable
  • Proficient with NanoString, scRNA-seq, CITE-seq, and/or other single cell RNA sequencing technologies; experience with RT PCR, qPCR, and ddPCR is highly desirable
  • Experience with Design of Experiment (DoEs) using JMP or other statistical software
  • Expertise with multi-dimensional analyses ( e.g. CytoBank, viSNE, SPADE, CITRUS, Sunburst, etc .)
  • Expert in media optimization, T cell stimulation, transduction, primary cell expansion, and/or cryopreservation
  • Experienced with regulatory filings and communications
  • Experience qualifying and/or validating analytical methodsand experience transferring analytical methods between labs/testing sites


DUTIES AND RESPONSIBILITIES:
  • Management and mentorship of 3+ individuals
  • Subject matter expert responsible for evaluating technology platforms, developing robust analytical methods, and expanding product understanding
  • Provide analytical expertise to development studies that refine the manufacturing process to improve product quality
  • Establish and/or maintain best practices for new technology platforms, techniques, and/or methods
  • Review and approve technical documents, including methods, protocols, technical reports, and SOPs
  • Regulatory filings, responses, and communication
  • Manage all aspects of method development, training, and transfer of analytical methods
  • Proficiency of ICH/FDA/EMEA regulations and guidance and knowledge of USP, EP, and JP


WORKING CONDITIONS (US Only):
  • Office and laboratory environments with a mix of natural and LED lighting with low level of background noise. Required computer and conferencing hardware are provided. 40% seated at a desk with ergonomic and sit/stand desks and 60% time in laboratory or meetings.
  • Local, national, and international travel up to 25%
  • This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
  • This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.


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 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.


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