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

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

The Senior Scientist role is a technical expert supporting the Cellular Therapy product portfolio. Successful candidates will have a strong foundation in designing and conducting experiments at the laboratory bench, analyzing data, and interpreting results in bioassay, flow cytometry or molecular biology methods, or a combination thereof. This role will perform hands-on laboratory experiments in support of QC analytical methods.

Duties/Responsibilities

· Provide bioassay, flow cytometry and/or molecular biology analytical expertise in support of QC lab investigations. This encompasses supporting technical investigations to identify root cause and provide corrective and preventive actions, including method remediations and experimental studies at the bench.

· In accordance with established protocols and research objectives, design, plan and independently execute experimental work with a high degree of technical proficiency, contribute to data analysis and documentation, and collaborate within cross-functional teams. Contribute to the development and optimization of new and existing laboratory methods and protocols.

· Present experimental findings and progress updates to immediate team. Support the preparation of internal technical reports and presentations as appropriate.

· Support transfer of commercial methods and method validation in compliance with global regulatory requirements.

· Responsible for the stewardship of bioassay, flow cytometry and/or molecular methods in the Cell Therapy Quality organization.

· Implement method lifecycle and method maintenance programs to support bioassay, flow cytometry and/or molecular biology methods in support of cell therapy drug products.

· Author, revise, and review technical documents such as test methods, SOPs, trend reports, and/or investigation reports as appropriate.

· Lead project, CAPA and deviation/ investigation related tasks and/or continuous improvement efforts.

· Provide support in the authoring of the analytical sections of regulatory submissions, responding to health authority questions and to function as the method validation and method transfer expert during inspections as required.

· Partner with development organizations in the design of development and qualification studies, selection and characterization of reagents, and method optimization initiatives. Represent the function on cross-functional project teams.

· Train and mentor others on cell biology/molecular biology/ flow cytometry techniques, methods and procedures.

· Champion and foster a positive and successful collaborative quality culture.

· Perform other tasks as assigned.

Reporting Relationship

This position will report to Cell Therapy Global Quality Analytical Sciences and Technology (ASAT) management.

Qualifications

· Bachelor’s degree in relevant scientific discipline or equivalent is required. Advanced degree preferred.

· 8+ years of relevant analytical experience or equivalent combination of education and experience, preferably in a regulated environment (GMP), cellular therapy, or gene therapy.

· Advance experience and strong scientific background and expertise, encompassing various cell-therapy relevant methodologies. Bioassay: Cell-based bioassays such as potency, reporter gene assays, cell counting. Flow Cytometry: Range of instrument platforms and standardization, multiparameter applications, antibody titration. Molecular Biology: Molecular methodologies including those related to lentiviral, AAV vectors and other gene delivery platforms.

· Hands-on laboratory experience and demonstrated proficiency with standard laboratory techniques relevant to the role.

· Experience in analytical method lifecycle, including method transfer, validation, and maintenance. Experience providing training in method execution as well as instrument operation and standardization.

· Experience in cGMP regulations and application within the Quality Control environment.

· Strong understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of viral vectors, cell therapies, vaccines and/or biological products.

· Must possess effective time management skills, demonstrate initiative, resourcefulness, and flexibility to work independently and as part of a team.

· Strong technical writing experience (SOPs, Method Validation Protocols and Reports) is required.

· Advance ability to communicate effectively with peers, department management, cross-functional peers.

· Ability to travel to other BMS sites or Partner sites is required.

We hire for skills and capabilities, not just credentials - if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

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, employees may also have access to additional time-off benefits, including 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 also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings athttps://careers.bms.com/benefits

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [email protected] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1602886 : Senior Scientist, Drug Product Analytical Science (ASAT), Cell Therapy