Senior Manager, Principal Scientist (Analytical Science & Technology, Cell Therapy Quality)

Company: Bristol Myers Squibb
Location: Ayer
Posted on: November 21, 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. 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. The Cellular Therapy Quality (CTQ) organization is seeking a Principal Scientist/Senior Manager who will be responsible for the quality oversight of Flow Cytometry methods in support of the Cellular Therapy product portfolio.This position will report into the Analytical Science & Technology (AS&T) group within the CTQ organization. Successful candidates will have a strong foundation in multi-parameter flow cytometry assays and demonstrated experience working in a cGMP environment. Responsibilities:

• Responsible for the stewardship of late-phase flow cytometry methods in the Quality organization.
• Implement method lifecycle and method maintenance programs to support flow cytometry methods used in the release of cell therapy drug products.
• Responsible for transfer and validation of methods from Development to Quality Control (QC) laboratories in compliance with global regulatory requirements.
• 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 reagents, and method optimization initiatives. Represent the QC department on cross-functional project development teams.Qualifications and Education Requirements
  • MS/PhD in relevant scientific discipline and 10+ years (or equivalent combination) experience in multi-parameter (> 10-color) flow cytometry execution, training, and technical support. Experience in cellular therapies is preferred.
  • Strong scientific background and expertise with multiple flow cytometry platforms from analyzers to cell sorters.
  • Experience in analytical method lifecycle, including method transfer, validation and maintenance. Experience providing training in method execution as well as instrument operation and standardization. Experience with implementing flow cytometry methods in a commercial QC facility 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.
  • 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 essential. If you want to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today. , , 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 . Visit to access our complete Equal Employment Opportunity statement. 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: Bristol Myers Squibb, Nashua , Senior Manager, Principal Scientist (Analytical Science & Technology, Cell Therapy Quality), Healthcare , Ayer, New Hampshire