Associate Scientist, QC Cell Therapy Bioanalytics

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 rich in diversity. 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.

Title: Associate QC Scientist, Cell Therapy Bioanalytics, CAR-T

Location: Warren, NJ

The QC Associate Scientist is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products.  This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will be able to assist with training and assay transfer.

Qualifications & Experience

• Bachelor’s degree required, preferably in Science.
• 3-5 years of relevant work experience, preferably in a regulated environment.
• An equivalent combination of education and experience may substitute.

• Hands-on experience with various bioanalytical techniques in Flow.  Experience with Elisa and qPCR is a plus.
• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Technical writing skills.
• Problem-solving ability/mentality, technically adept and logical.
• Ability to represent the interests of the group on cross-functional teams.
• Ability to set priorities of the group and manage timelines.
• Ability to work with management locally and globally.
• Ability to communicate effectively with peers, department management and cross-functional peers.

Key Responsibilities

Perform testing of in-process, final product, and stability samples.

• Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
• Anticipate and troubleshoot problems.
• Recommend corrective actions and participate in the development of best practices.
• Understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.
• Complete all work in a timely manner.
• Work and communicate effectively within the team to ensure timelines are met.

Perform peer review of testing data.

•  Review all data in accordance with applicable procedures and cGMP requirements.
•  Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
• Complete all review in accordance with required release timelines.
• Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.

Train new analysts to general job duties.

• Complete necessary training to become a qualified trainer.
• Perform training effectively.
• Document training per procedural and cGMP requirements.

Support document revision, project, CAPA, and investigation/deviation related tasks.

• Perform assigned tasks within a CAPA, deviation, or project
• Draft and review technical documents, such as SOPs and protocols/reports.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.
• Performs other tasks as assigned.

Working Conditions

• The incumbent should be able to distinguish colors and possess correctable vision to