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

Bristol Myers Squibb • Madison, WI

18d • $108,210 - $144,241

About The Position

The Senior Scientist is a technical expert supporting Bristol Myers Squibb’s Cellular Therapy product portfolio. The role conducts hands-on laboratory experiments in support of QC analytical methods, with expertise in bioassay, flow cytometry, molecular biology, or a combination of these areas. The scientist independently designs and executes experiments, analyzes and documents results, and contributes to development and optimization of laboratory methods and protocols.

The position supports analytical method transfer, validation, lifecycle stewardship, and maintenance for cell therapy drug products, in compliance with global regulatory requirements. It also contributes to QC investigations, root-cause analysis, corrective and preventive actions, regulatory submissions, health authority responses, and inspection readiness. The role collaborates with development organizations and cross-functional teams, and trains and mentors colleagues in relevant techniques and procedures.

The position reports to Cell Therapy Global Quality Analytical Sciences and Technology (ASAT) management. Ability to travel to other BMS or partner sites is required. The posting lists full-time salary ranges by location: $108,210–$131,129 for Madison/Giralda, New Jersey and Summit West, New Jersey; and $119,030–$144,241 for Seattle, Washington. Eligible employees may receive discretionary cash and stock incentives and may participate in the company’s benefit and time-off programs.

Requirements

• Bachelor’s degree in a relevant scientific discipline or equivalent combination of education and experience.
• At least 8 years of relevant analytical experience, or an equivalent combination of education and experience.
• Advanced experience and strong scientific background in cell-therapy-relevant methodologies, including cell-based bioassays such as potency, reporter gene assays, and cell counting; flow cytometry platforms, standardization, multiparameter applications, and antibody titration; and molecular methods related to lentiviral, AAV vectors, and other gene-delivery platforms.
• Hands-on laboratory experience and demonstrated proficiency in standard laboratory techniques relevant to the role.
• Experience in analytical method lifecycle activities, 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 related 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, method validation protocols, and reports.
• 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 preferred.
• Relevant analytical experience in a regulated (GMP) environment, cellular therapy, or gene therapy is preferred.

Responsibilities

• Provide bioassay, flow cytometry, and/or molecular biology expertise for QC laboratory investigations, including technical investigations, root-cause identification, corrective and preventive actions, method remediation, and bench studies.
• Design, plan, and independently execute experimental work in accordance with protocols and research objectives; contribute to data analysis, documentation, and cross-functional collaboration.
• Contribute to development and optimization of laboratory methods and protocols.
• Present experimental findings and progress updates to the immediate team 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, including 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 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 on cell biology, molecular biology, and flow cytometry techniques, methods, and procedures.
• Champion and foster a positive, collaborative quality culture.
• Perform other tasks as assigned.
• Travel to other BMS sites or partner sites as required.

Benefits

• Wellbeing support.
• Retirement and financial protection benefits.
• Medical, dental, vision, life, and disability insurance offerings, subject to applicable plan terms and eligibility.
• Flexible Time Off without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• For specified employee groups, 160 hours of annual paid vacation for new hires, subject to manager approval.
• 11 paid company holidays; specified employee groups also receive 3 optional holidays.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and medical, personal, parental, caregiver, bereavement, or military leaves of absence.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year’s Day.
• Potential eligibility for additional discretionary incentive cash and stock opportunities.

What This Job Offers

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