Senior Specialist, QC Analytical

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:  .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.

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