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

Bristol Myers Squibb • Madison, NJ

12d • $117,150 - $141,955

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 experience in bioassays, including designing and independently executing experiments, analyzing complex data, interpreting results, troubleshooting assay performance, and translating findings into technically sound recommendations. The position supports the optimization, transfer, validation, maintenance, and investigation of QC analytical methods, with particular emphasis on cell-based bioassays. Experience in a regulated laboratory environment is desired, while scientific depth, experimental rigor, and analytical problem-solving are primary qualifications.

The position reports to Cell Therapy Global Quality Analytical Sciences and Technology (ASAT) management. It collaborates with Quality Control, development organizations, and cross-functional project teams; contributes to method lifecycle activities and regulatory submissions; and trains and mentors colleagues in cell biology techniques, methods, and procedures. The role requires travel to other BMS or partner sites.

Requirements

• Bachelor’s degree plus 8 years, master’s degree plus 4 years, or PhD plus 2 years 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 a strong scientific background in cell-therapy-relevant methodologies, including cell-based bioassays such as potency assays, reporter gene assays, and cell counting related to lentiviral vectors, AAV vectors, and other gene delivery platforms.
• Hands-on laboratory experience and demonstrated proficiency with standard laboratory techniques relevant to the role.
• Experience in the analytical method lifecycle, including method transfer, validation, and maintenance.
• Strong technical writing experience, including SOPs and method validation protocols and reports.
• Strong understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations concerning 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.
• Advanced ability to communicate effectively with peers, department management, and cross-functional colleagues.
• Ability to travel to other BMS or partner sites.

Nice To Haves

• Advanced degree.
• 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 in cGMP regulations and their application in a Quality Control environment.
• Experience providing training in method execution, instrument operation, and standardization.

Responsibilities

• Serve as a scientific subject matter expert and steward for 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-based experimental studies.
• Design, plan, and independently execute laboratory experiments, including appropriate controls, experimental design, data analysis, interpretation, and scientifically justified conclusions.
• Collaborate with cross-functional teams and contribute to the development and optimization of 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.
• Implement method lifecycle and method maintenance programs for bioassays 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, and continuous-improvement tasks as applicable.
• Support authoring analytical sections of regulatory submissions, responding to health authority questions, and serving as a method validation and method transfer expert during inspections.
• Partner with development organizations on development and qualification study design, reagent selection and characterization, and method optimization; represent the function on cross-functional project teams.
• Train and mentor others on cell biology techniques, methods, and procedures.
• Promote a positive, collaborative quality culture.
• Perform other tasks as assigned.

Benefits

• 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 annually.
• Non-exempt employees, RayzeBio employees, and employees 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 of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees 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