Senior Specialist, QC Analytical
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.
About the role
This 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 with minimal guidance, the ability to interface with multiple cross-functional groups, and the ability to work in a fast-paced team environment.
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.
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.
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, 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.
Working Conditions
- Ability to lift up to 45 lbs at floor and waist height.
- 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.
Pay
Summit West - NJ - US: $40.97 - $49.64 per hour 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.
Benefits
- 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 for 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, and an annual Global Shutdown between Christmas and New Year’s Day.
All global employees (full and part-time) who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.