Senior Associate Scientist Life Cycle Management

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. or M.S. or PhD in Biochemical, Chemical, or Biomedical Engineering or Biology or related discipline with relevant experience

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 :


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 or PhD with 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


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.

Company: Bristol-Myers Squibb

Req Number: R1520261_EN

Updated: 2020-01-28 00:00:00.000 UTC

Location: Seattle,Washington

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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

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