Principal Scientist, Flow Cytometry, Analytical Sciences & Technology (CTQ) Apply locations Seattle - WA - US
time type Full time
posted on Posted 6 Days Ago
job requisition id R1586582
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.
Position Summary: BMS is seeking a Principal Scientist for the Cellular Therapies Development and Operations (CTDO) organization who will be responsible for the Quality oversight of Flow Cytometry 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 flow cytometry methods as well as a demonstrated experience working in a cGMP environment.
Responsibilities: Responsible for the life-cycle management of commercial flow cytometry methods 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 flow cytometry 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 flow cytometry 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 & Experience: BS/MS in relevant scientific discipline and 7+ years experience designing and leading flow cytometry method validations and method transfers is required. Experience in cellular therapies is preferred. Strong scientific background and expertise with a range of flow cytometry platforms from analyzers to cell sorters, multi-parameter flow cytometry methods and antibody titration and qualification procedures is required. Experience with spectral flow cytometry, auto-gating algorithms and implementation of automated platforms is highly desired. Must be able to function independently as lead investigator and lead analytical investigations. Experience with implementing flow cytometry 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. Strong technical writing experience (SOPs, Method Validation Protocols and Reports) is required. The starting compensation for this job in Seattle, WA is a range from $127,000-$159,000, plus incentive cash and stock opportunities (based on eligibility).
Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
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