Senior Scientist, Product and Analytical Sciences

Bristol Myers Squibb • Seattle, WA

20h

About The Position

The Cell Therapy Product and Analytical Sciences (PAS) team is seeking a Senior Scientist to support the development of the Allogeneic Cell Therapy pipeline programs. The goal of BMS Cell Therapy is to revolutionize medicine by re-directing the body’s immune cells to specifically target cancer cells. Allogeneic or “off-the-shelf” CAR T cells are generated from healthy donor-derived T cells rather than the patient’s T cells and can be delivered to patients without manufacturing wait time. The Product and Analytical Sciences Team is responsible for developing and executing in depth donor starting materials and drug product characterization strategies, as well as mechanism of action studies to support the development of allogeneic and autologous CAR T cell therapies. The primary focus of the Product and Analytical Senior Scientist role will be to collaborate with PAS team members to build in depth allogeneic CAR T cell donor, product and manufacturing process knowledge, with particular focus on exploratory/investigational studies to drive: In depth Healthy Donor cellular starting materials characterization to support donor pre-screening, selection, cell sourcing workflows across allogeneic cell therapy program Developing and executing complex cellular immunoassays and generating comprehensive datasets for correlative analysis execution and the building of in-depth donor > manufacturing process > drug product understanding across pipeline Allogeneic Cell Therapy Programs Support process development studies and investigations by building and mining in depth data packages and generating hypothesis-driven conclusions and proposed risk mitigation strategies Support the identification of drug product critical quality attributes (CQA) to inform the overall drug product control strategy and the generation of drug product quality target product profiles taking into account safety and efficacy of drug products Generate in-depth product characterization data packages for inclusion in regulatory submissions (with specific attention to Module 3 S.3.1. Elucidation of Structure and S.3.2. Product Impurities) and to answer agencies’ information requests Successful candidates will have a strong foundation in Immunology and human T cell biology and experience with the design, optimization, and implementation of a broad range of in vitro cell-based and/or molecular T cell characterization assays (i.e. cytotoxicity assays, proliferation, cytokine production assays, multi-color conventional and spectral flow cytometry, gene editing, transcriptome and proteome profiling, etc.). Prior research experience with T cells / CAR T cells (including cell therapy research, allogeneic hematopoietic stem cell transplantation, etc) will be prioritized. This role is highly collaborative and requires strong ability to prioritize deliverables, independence, a demonstrated ability to support cross-functional teams, attention to detail, a healthy sense of urgency, and a passion for exploratory and investigational science. Candidates with prior people management experience will be prioritized.

Requirements

• PhD and 3+ years; MS and 10+ years; BS and 12+ years in Immunology, Cell Biology, Bioengineering, or relevant discipline
• Expertise in cellular and molecular immunology. Prior research with cell therapy products (i.e. autologous or allogeneic T/CAR T cells, NK cells, HSC and/or iPSC) will be prioritized
• Experience with routine and next generation analytical platforms for the characterization of T cell phenotype, differentiation, and function (i.e. cell-based immunoassays, cytokine/proteome analysis platforms, in vitro live imaging systems, conventional and spectral flow cytometry, metabolic profiling, CRISPR and gene editing, transcriptome and proteome profiling, etc)
• Experience with data analysis and visualization software (Flowjo, OMIQ, JMP, EXCEL, etc.) and/or coding-based analysis (R, Python, etc.)
• Independence in experimental design, data analysis, interpretation, and presentation
• Ability to work in a high-paced, cross-functional team environment, meet deadlines, & prioritize work on multiple projects
• Attention to detail and excellent interpersonal, written and verbal communication skills
• Experience in managing and/or mentoring more junior scientists

Nice To Haves

• Experience with big/omic data analysis will be prioritized
• Track record of successful internal and/or external scientific collaborations

Responsibilities

• Work collaboratively with the Product and Analytical Sciences Team members to identify, prioritize and support immediate PAS team goals
• Design, optimize, and execute in-depth characterization experiments and generate comprehensive characterization data packages focused on allogeneic cell therapy starting materials and pipeline CAR T cell products to enable immediate PAS team deliverables, leveraging cutting edge phenotypic, functional, metabolic, gene expression profiling tools and platforms
• Answer high priority PAS Team targeted questions, such as identification of donor starting material attributes that best correlate with high quality drug product manufacturing, investigation of product mechanisms of action (MoA), manufacturing investigations, responses agency’s information requests (IRs), data package generation in support of regulatory document submissions
• Present experimental findings and project updates at cross-functional team meetings and to BMS leadership
• Serve as allogeneic starting materials and product biology subject matter expert in multidisciplinary team settings that includes CMC functions, regulatory, non-clinical, clinical, translational teams
• Collaborate with members of the Product and Analytical Sciences Team to identify, prioritize, and develop novel/next generation Analytical Platforms and Technologies to interrogate cell therapy starting materials and drug product function
• Author, review, and approve electronic notebook entries (ELN), technical documents, including methods, protocols, reports, and SOPs
• Execute method and instrument troubleshooting

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree