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Job Details


Bristol Myers Squibb

Manager, Bioassay Scientist, Cell Therapy (R1553951-en-us)

Science and Research

Scientist

Yearly

No

Seattle, Washington, United States

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.

The Quality Cellular Therapies organization is seeking a Manager who will be responsible for analytical lifecycle activities to support Cell Therapy drug product and vector programs. Reporting into the commercial Analytical Sciences & Technology function, this role is accountable for managing analytical life cycle activities with a focus on coordination of method transfer and validation activities. Successful candidates will have a strong foundation in biochemical/immunological methods and demonstrated experience working in a cGMP environment.

Responsibilities:

  • Responsible for the life-cycle management of late-phase cell-based potency assays, and general characteristic methods in the Quality organization.
  • Responsible for transfer and validation of methods from Development Laboratories to Quality Control (QC) in compliance with global regulatory requirements.
  • Implement method lifecycle and method maintenance programs to support bioassay and cell-based methods used in the release cell therapy drug products.
  • Responsible for authoring relevant analytical sections of submissions, responding to health authority questions and representing the QC function during inspections.
  • Function as the bioassay technical expert for QC labs during internal QC investigations and as the Quality liaison with contract test labs during QC investigations.
  • Partner with development organizations in the design of development and qualification studies, selection and characterization of critical reagents, and method optimization initiatives. Represent the QC department on cross-functional project development teams.

Qualifications and Education Requirements

  • BS/MS in relevant scientific discipline and 7 years experience with bioassay/potency method validations and method transfers is required.
  • Strong scientific background and expertise with cell-based potency assays (ELISA, Luminex etc) in a Quality Control setting is required. Experience with implementation of automated platforms is preferred.
  • Experience with implementing bioassay methods in a commercial QC facility is required. Demonstrated experience in method lifecycle management in a commercial environment is desired. Experience training QC analysts in method execution and instrument operation and strong technical writing experience (SOPs, Method Validation Protocols and Reports) is required.
  • Experience in cGMP regulations and application within the Quality Control environment. Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products is required.
  • Must possess effective time management skills, demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.