Principal Scientist, Bioanalytical Development

Company: Bristol Myers Squibb
Location: Seattle
Posted on: May 14, 2022

Job Description:

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.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.Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS's continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.Position Summary:Cell Therapy Product and Analytical Development (P&AD) is seeking an enthusiastic, self-driven Principal Scientist to join its Residual, Ancillary Materials and Protein Characterization analytical development team. The Principal Scientist will lead development of analytical methods to characterize process-related impurities and assess impurity clearance in autologous and allogenic cell therapies. The Principal Scientist will be responsible for developing impactful methods, including QC methods for lot release testing as well as characterization methods that support process development and comparability assessments. These methods will be used to further our understanding of cell therapies, and support development of manufacturing processes, and/or QC release of the drug product. The successful candidate must have extensive hands-on experience in assay development and possess excellent communication skills in order to work on projects requiring close collaboration with other groups, such as discovery research, product sciences, process development, and QC. Additionally, the Principal Scientist will interface with external vendors (e.g., CMO's) for the successful management of any transferred analytical methods. The Principal Scientist should be passionate about developing novel medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of likeminded scientists.Roles and Responsibilities

• Serve as a subject matter expert responsible for developing robust analytical methods and expanding product and process understanding
• Independently develop and execute bioanalytical or molecular assays (e.g. chromatography, electrophoresis/CE, qPCR assays)
• Identify issues, lead troubleshooting experiments, and determine solutions with minimal to no guidance
• Train users on method execution, data analyses, and proper use of instrumentation
• Lead qualification and transfer of analytical methods to external stakeholders
• Routinely present work at team, technical team, and department meetings
• Maintain meticulous laboratory notebooks
• Analyze, interpret, and present data to internal and external stakeholders
• Author, review and approve technical documents, including methods, protocols, reports, and SOPs
• Deliver lifecycle-managed analytical methods for multiple programs with an understanding of ICH/FDA/EMEA best practices and current thinking.
• Supervise and mentor technical staff
• Facilitate smooth operation of the laboratory, including ordering, assisting in the cryopreservation of cellular material, sample management, etc.Qualifications & ExperienceEducation
  • Advanced degree in Molecular Biology, Analytical Biochemistry, Immunology, Microbiology, Cell Biology, or related field. PhD with 5+ years of industry experience, MS with commensurate amount of industry experience.Basic Qualifications
    • Proven experience with physicochemical analytical techniques such as chromatography, electrophoresis/CE, qPCR, etc.
    • Strong problem-solving ability to troubleshoot complex technical and scientific problems.
    • Experience with writing technical and regulatory documents for interdepartmental use and external vendors (e.g., CMO's).
    • Strong attention to detail and timelines.
    • Outstanding written and oral communication skills.
    • Strong interpersonal skills - ability to work effectively in a collaborative team setting.
    • Ability to work in a rapidly changing environment with frequent changes in priorities.
    • Supervisory, mentorship, or leadership experiencePreferred Qualifications
      • Knowledge of immunology and T cell biology as applied to the cell therapy field
      • Knowledge of or experience with vector analytics
      • Experience with molecular techniques (e.g., qPCR, RT-qPCR, and/or ddPCR).
      • Experience with data analysis and interpretation using software (e.g., Softmax Pro, Gen5, Excel, Prism Graphpad).
      • Familiarity with statistical analysis and design on experiments (DoE) using JMP software.
      • Track record of successful transfer and management of analytical methodsBMSCARTAround 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.

Keywords: Bristol Myers Squibb, Seattle , Principal Scientist, Bioanalytical Development, Other , Seattle, Washington