Bristol Myers Squibb Company

Associate Scientist - Senior Associate Scientist, Cell Therapy Process Development

Location
Seattle, WA, United States
Posted
Aug 21, 2020
Ref
R1520261
Required Education
Bachelors Degree
Position Type
Full time
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.

Summary:

The individual will be a key contributor to the development of Chimeric Antigen Receptor (CARs) and T Cell Receptors (TCRs) late-stage manufacturing process. He/she will design, perform, and interpret complex experiments in collaboration with other process and analytical engineers focused on delivering robust CARs and TCRs manufacturing process. This individual will be involved in the implementation of new technologies and author part of commercial filing submissions for late stage/commercial programs. The successful candidate will work in a cross-functional and collaborative environment and able to provide guidance for cell culture experiments to enable understanding of process and how it impacts drug product attributes.

Responsibilities will include, but are not limited to, the following:
  • Independently design and execute complex development experiments in order to support cell therapy process development
  • Maintain proficiency in data analysis, statistical analysis, and effective data presentation within a cross-functional team
  • Author technical reports detailing experimental work and summarizing conclusions
  • Manage phase-appropriate process-related document lifecycle as it relates to new process transfer and process improvement implementation
  • Perform process residual modeling for process-related impurity risk assessments
  • Participate in appropriate regulatory filing activities
  • Interact with Analytical Development, Quality, Manufacturing, Regulatory, Pre-Clinical, and Clinical and other personnel as dictated by project need.
  • Leverage and maintain strong relationships with external partners.
  • Define/maintain a safe work environment in accordance with policies/procedures/regulations


Skills/Knowledge Required:
  • Senior Associate Scientist: B.S. in Biochemical, Chemical, or Biomedical Engineering or Biology related discipline with 5 - 8 years of relevant experience or M.S. with 4-7 years of relevant experience
  • Associate Scientist: B.S. in Biochemical, Chemical, or Biomedical Engineering or Biology related discipline with 4 - 6 years of relevant experience or M.S. with 3-5 years of relevant experience
  • Familiarity with product lifecycle management
  • Excellent organization skills and ability to handle multiple tasks
  • Highly motivated, willingness to acquire new skills and ability to work without supervision
  • Strong engineering or scientific knowledge appropriate for cellular process development
  • Ability to assess risk and develop contingency plans for process risks
  • Mastery of mammalian cell culture and aseptic technique
  • Experience working in a regulated environment and preparing regulatory documents
  • Interpersonal and leadership skills to work with teams in different functions and organizations


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.