Senior Scientist, Drug Product Analytical Sciences (ASAT), Cell Therapy

Bristol Myers Squibb • Madison, NJ

17d

About The Position

The Senior Scientist is a technical expert supporting Bristol Myers Squibb’s Cellular Therapy product portfolio. The role performs hands-on laboratory experiments in support of Quality Control analytical methods, drawing on expertise in bioassay, flow cytometry, molecular biology, or a combination of these areas. The scientist independently designs and executes experimental work, analyzes and documents results, contributes to method development and optimization, and collaborates across functions.

The position supports method transfer, validation, lifecycle management, and maintenance for cell therapy drug product methods. It also contributes technical expertise to laboratory investigations, regulatory submissions and health authority responses, and inspection readiness. The role reports to Cell Therapy Global Quality Analytical Sciences and Technology (ASAT) management and may require travel to other BMS or partner sites.

Requirements

• Bachelor’s degree in a relevant scientific discipline or equivalent.
• At least 8 years of relevant analytical experience, or an equivalent combination of education and experience.
• Advanced experience and strong scientific expertise in cell-therapy-relevant methodologies, including cell-based bioassays, flow cytometry, and/or molecular biology methods.
• Hands-on laboratory experience and demonstrated proficiency with standard laboratory techniques relevant to the role.
• Experience with the analytical method lifecycle, including method transfer, validation, and maintenance.
• Experience training others in method execution, instrument operation, and standardization.
• Experience with cGMP regulations and their application in a Quality Control environment.
• Strong understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations relevant to quality control of viral vectors, cell therapies, vaccines, and/or biological products.
• Effective time-management skills, initiative, resourcefulness, and flexibility to work independently and as part of a team.
• Strong technical writing experience, including SOPs and method validation protocols and reports.
• Ability to communicate effectively with peers, department management, and cross-functional peers.
• Ability to travel to other BMS sites or partner sites.

Nice To Haves

• Advanced degree.
• Relevant analytical experience in a regulated (GMP) environment, cellular therapy, or gene therapy.
• Experience with cell-based bioassays such as potency assays, reporter gene assays, and cell counting.
• Experience with a range of flow cytometry instrument platforms and standardization, multiparameter applications, and antibody titration.
• Experience with molecular methodologies related to lentiviral and AAV vectors and other gene delivery platforms.

Responsibilities

• Provide bioassay, flow cytometry, and/or molecular biology expertise for QC laboratory investigations, including root-cause analysis, corrective and preventive actions, method remediation, and bench studies.
• Design, plan, and independently execute experimental work; contribute to data analysis and documentation; collaborate with cross-functional teams; and contribute to developing and optimizing laboratory methods and protocols.
• Present experimental findings and progress updates, and support preparation of internal technical reports and presentations.
• Support transfer of commercial methods and method validation in compliance with global regulatory requirements.
• Steward bioassay, flow cytometry, and/or molecular methods in the Cell Therapy Quality organization.
• Implement method lifecycle and maintenance programs for methods supporting cell therapy drug products.
• Author, revise, and review technical documents such as test methods, SOPs, trend reports, and investigation reports.
• Lead project, CAPA, deviation/investigation-related tasks, and continuous improvement efforts.
• Support authoring analytical sections of regulatory submissions, respond to health authority questions, and serve as a method validation and method transfer expert during inspections as required.
• Partner with development organizations on development and qualification studies, reagent selection and characterization, and method optimization; represent the function on cross-functional project teams.
• Train and mentor others in cell biology, molecular biology, and flow cytometry techniques, methods, and procedures.
• Promote a positive and collaborative quality culture.
• Perform other tasks as assigned.
• Travel to other BMS or partner sites as required.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• Eligible U.S.-based exempt employees may receive Flexible Time Off without a set accrual limit, subject to manager approval, and 11 paid company holidays.
• Other eligible employees may 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.
• May be eligible for additional discretionary incentive cash and stock opportunities.

What This Job Offers

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