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Principal Scientist, Analytical Science & Technology, Cell Therapy

Company: Disability Solutions
Location: Seattle
Posted on: July 2, 2024

Job Description:

Working with UsChallenging. 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: .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. Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science--- , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement. 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. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Disability Solutions, Seattle , Principal Scientist, Analytical Science & Technology, Cell Therapy, IT / Software / Systems , Seattle, Washington

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