Principal Scientist, Analytical Science & Technology, Cell Therapy

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

BMS is seeking a Principal Scientist for the Cellular Therapies Development and Operations (CTDO) organization who will be responsible for the Quality oversight of Potency in support of the Cellular Therapy product portfolio.  This position will report into the Analytical Science & Technology group. Successful candidates will have a strong foundation in biochemical/immunological methods as well as a demonstrated experience working in a cGMP environment. 

Key Responsibilities:

• Responsible for the life-cycle management of commercial bioassay/cell-based (relative) potency assays in the Quality organization.

• Responsible for transfer and validation of methods in the commercial environment in compliance with global regulatory requirements.

• Implement method lifecycle and method maintenance programs to support bioassay/potency 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 commercial QC function on cross-functional project development teams.

Qualifications and Experience:

• BS/MS in relevant scientific discipline and 7+ years experience designing and leading bioassay/cell-based (relative) potency method validations and method transfers is required. Experience in cellular therapies is preferred.

• Strong scientific background and expertise with bioassay/potency assays (functional potency assay, ELISA, Luminex etc) in the biologics and/or cell therapy industry. Must be able to function independently as the lead investigator and lead analytical investigations.

• Experience with implementing bioassay/potency 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 with implementation of automated platforms is preferred.

• 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. Strong technical writing experience (SOPs, Method Validation Protocols and Reports) is required.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.