Senior Specialist QC Analytical Cell Therapy
Bristol Myers Squibb
Summary
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.
Job description
Shift: Wednesday - Saturday, AM (6:30AM-4:30PM)
Duties/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.
Job Safety Requirements & Essential Physical Demands
- 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.
Qualifications
Specific Knowledge, Skills, Abilities
- 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.
Education/Experience/Licenses/Certifications
- 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.
- Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique).
Requirements
- Bachelor's degree or equivalent required, preferably in Science
- 4+ years of relevant analytical testing or QC experience or equivalent combination of education and experience
- Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique)
- Ability to 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
- 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
- Advanced degree preferred
Benefits
- Wellbeing Support
- Retirement Benefits
- Financial Protection Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Flexible Time Off
- 11 Paid Company Holidays
- Paid Sick Leave
- Paid Volunteer Days
- Summer Hours Flexibility
- Leaves of Absence
- Annual Global Shutdown
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.