Senior Scientist, Drug Product Analytical Science and Technology (ASAT), Cell Therapy

Bristol Myers Squibb • Seattle, WA

10d

About The Position

The Senior Scientist is a scientific and technical expert supporting Bristol Myers Squibb’s Cell Therapy product portfolio. The role requires strong hands-on laboratory capabilities and deep bioassay experience, including the ability to design and independently execute experiments, analyze complex data, interpret results, troubleshoot assay performance, and translate findings into technically sound recommendations.

The position performs laboratory studies supporting the optimization, transfer, validation, maintenance, and investigation of QC analytical methods. It serves as a scientific subject matter expert and steward for bioassay methods used for cell therapy drug products, supports method lifecycle programs, and contributes to regulatory submissions and inspection readiness. The role collaborates with cross-functional teams, development organizations, and other sites or partners, and trains and mentors colleagues. The position reports to Cell Therapy Global Quality Analytical Sciences and Technology (ASAT) management.

Requirements

• Bachelor’s degree plus 8 years, master’s degree plus 4 years, or Ph.D. plus 2 years in a relevant scientific discipline or equivalent.
• 8 or more years of relevant analytical experience or an equivalent combination of education and experience.
• Advanced experience and strong scientific background in methodologies relevant to cell therapy.
• Expertise in cell-based bioassays, including potency assays, reporter gene assays, and cell counting, including methods related to lentiviral and AAV vectors and other gene delivery platforms.
• Hands-on laboratory experience and demonstrated proficiency with standard laboratory techniques relevant to the role.
• Experience with analytical method lifecycle activities, including method transfer, validation, and maintenance.
• Experience training others in method execution, instrument operation, and standardization.
• Strong understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations for quality control of viral vectors, cell therapies, vaccines, and/or biological products.
• Strong technical writing experience, including SOPs and method validation protocols and reports.
• Effective time-management skills, initiative, resourcefulness, and flexibility to work independently and as part of a team.
• Advanced ability to communicate effectively with peers, department management, and cross-functional peers.
• Ability to travel to other BMS or partner sites.

Nice To Haves

• Advanced degree.
• Relevant analytical experience in a regulated environment, preferably GMP, cellular therapy, or gene therapy.
• Experience in other analytical areas, such as flow cytometry and molecular biology.
• Experience with cGMP regulations and their application in a Quality Control environment.

Responsibilities

• Serve as scientific subject matter expert and steward in the lifecycle of bioassay methods used for cell therapy drug products.
• Provide bioassay expertise, including cell-based potency assays, reporter gene assays, and cell counting, to support QC laboratory investigations.
• Support technical investigations to identify root causes and recommend corrective and preventive actions, including method remediation and bench studies.
• Design, plan, and independently execute laboratory experiments, including controls, experimental design, data analysis, interpretation, and scientifically justified conclusions.
• Collaborate with multiple cross-functional teams and represent the function on cross-functional project teams.
• Contribute to the development and optimization of new and existing laboratory methods and protocols.
• Present experimental findings and progress updates to the immediate team.
• Support preparation of internal technical reports and presentations.
• Support transfer of commercial methods and method validation in compliance with global regulatory requirements.
• Implement method lifecycle and maintenance programs for bioassay methods supporting cell therapy drug products.
• Author, revise, and review technical documents, including test methods, SOPs, trend reports, and investigation reports.
• Lead project, CAPA, deviation, investigation, and continuous improvement tasks as applicable.
• Support authoring analytical sections of regulatory submissions, respond to health authority questions, and serve as a method validation and transfer expert during inspections as required.
• Partner with development organizations to design development and qualification studies, select and characterize reagents, and optimize methods.
• Train and mentor others in cell biology techniques, methods, and procedures.
• Foster a positive, collaborative quality culture.
• Perform other tasks as assigned.

Benefits

• Comprehensive benefits, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• U.S.-based exempt employees are eligible for Flexible Time Off without a set accrual limit, subject to manager approval, and 11 paid company holidays.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires, subject to manager approval, 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Eligible employees may also be eligible for discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior