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

About the role

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Responsibilities

• Provide bioassay, flow cytometry and/or molecular biology analytical expertise in support of QC lab investigations, including root cause analysis, corrective and preventive actions, method remediations, and experimental studies at the bench.
• Design, plan, and independently execute experimental work with a high degree of technical proficiency in accordance with established protocols and research objectives; 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 the immediate team.
• Support the 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 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.
• Lead project, CAPA, deviation/investigation-related tasks, and/or continuous improvement efforts.
• Provide support in authoring analytical sections of regulatory submissions, respond to health authority questions, and 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, and flow cytometry techniques, methods, and procedures.
• Champion and foster a positive and successful collaborative quality culture.
• Perform other tasks as assigned.

Qualifications

• Bachelor’s degree in a 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.
• Advanced experience and strong scientific background in 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.
• Effective time management skills, initiative, resourcefulness, and flexibility to work independently and as part of a team.
• Strong technical writing experience (SOPs, Method Validation Protocols and Reports).
• Ability to communicate effectively with peers, department management, and cross-functional teams.
• Ability to travel to other BMS sites or Partner sites is required.

Pay

The starting compensation range(s) for this role are listed below for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may also be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

• Seattle, WA: $117,150 - $141,955
• Summit West, NJ: $106,500 - $129,049

Benefits

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment.

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life Benefits:
  • Paid Time Off:
    • US Exempt Employees: Flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or Rayzebio employees).
    • Phoenix, AZ, Puerto Rico, and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
  • Based on eligibility, additional time off may include:
    • Unlimited paid sick time.
    • Up to 2 paid volunteer days per year.
    • Summer hours flexibility.
    • Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.
    • Annual Global Shutdown between Christmas and New Year’s Day (for all global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year).

Schedule

BMS has an occupancy structure that determines where an employee is required to conduct their work. This role may be:

• Site-essential: Requires 100% of shifts onsite at your assigned facility.
• Site-by-design: Eligible for a hybrid work model with at least 50% onsite at your assigned facility. Onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive company culture.

For this role, the ability to physically travel to other BMS sites or Partner sites and attend meetings on behalf of BMS as directed is an essential job function.