Senior Specialist, QC Analytical

Bristol-Myers Squibb; Bend (OR); On-site; USD 56,000 - 69,000; Full time

Job summary

Bristol Myers Squibb is seeking a Senior Specialist for its CAR T Manufacturing QC Analytical team in Summit, NJ. The role supports in-process, final product, and stability testing, with emphasis on data review and GMP documentation.

The position requires strong problem-solving, cross-functional collaboration, and the ability to work in a fast-paced environment. The Senior Specialist will transfer/validate methods, review complex data, and contribute to investigations, CAPAs, and documentation

Qualifications

• Bachelor’s degree or equivalent in science is required; advanced degree preferred.
• 4+ years of analytical testing or QC experience in a regulated environment.
• Experience with cell/molecular biology techniques and GMP documentation.

Responsibilities

• Perform method transfer/validation and routine testing of samples.
• Review GMP documentation and data to support final product release.
• Train and mentor others on QC test methods and processes.
• Support continuous improvement and CAPA activities.

Skills

Cell biology techniques

GMP documentation

Data review

Problem solving

Communication

LIMS/ELN

Cross-functional teamwork

Education

Bachelor's degree in Science

Advanced degree preferred

Tools

LIMS

ELN

Job description

Working with Us 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. Read more: careers.bms.com/working-with-us.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure.

If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.

Senior Specialist

The Senior Specialist position is responsible for performing routine testing of in-process, final product, and stability samples in accordance with BMS policies, standards, procedures, and Global Regulatory and cGMP requirements to support the Quality Control Analytical department in the Bristol Myers Squibb (BMS) CAR T Manufacturing facility located in Summit, NJ. Additionally, this role performs data review for general and complex methods to support final drug product release. This position requires high problem-solving skills/mentality with minimal guidance, the ability to interface with multiple cross functional groups, as well as the ability to work in a fast-paced team environment. Shift Available: ?

Responsibilities

• Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
• Anticipate and perform routine troubleshooting and problem solving with minimal guidance.
• Perform data verification, data review and review of GMP documentation for general and complex methods.
• Perform document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
• Train and mentor others on QC test methods, processes, and procedures.
• Perform other tasks as assigned.

Knowledge & Skills

• Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique).
• Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
• Demonstrated technical writing skills.
• High problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.

Minimum Requirements

• Bachelor’s degree or equivalent required, preferably in Science.
• Advanced degree preferred.
• 4+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.

Working Conditions

• Ability to lift up to 45 lbs at floor and waist height (commonly <20 lbs), lift up to 10 lbs overhead, and push or maneuver carts to transport materials.
• Ability to operate and handle scissor lift carts requiring 15–20 lbs of initiation force.
• Ability to perform frequent pipetting and laboratory tasks within a biological safety cabinet, including prolonged seated work.
• Ability to independently don, doff, and wear required PPE (e.g., lab coat/frock, gloves, safety shoes, eye/face protection) during work shift, including cryogenic gloves as needed.
• Ability to safely handle chemical disinfectants, flammable materials, and hazardous chemicals.
• Work may involve handling liquid nitrogen and other cryogenically cooled materials.
• Ability to use step stools to reach and handle materials.

Compensation Overview

Summit West - NJ - US: $40.97 - $49.64 per hour. The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may 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. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: 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 include: 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 for employees 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,