Senior Specialist, Quality Control Analytical Testing

Senior Specialist, Quality Control Analytical Testing

Summit West - NJ - US

$82K - $99K

The QC Senior Scientist is responsible for supporting the analytical testing at the QC Analytical Testing department within the CAR T manufacturing facility during clinical and commercial phases. The department focuses on flow‑cytometry and molecular‑based testing for stability, validation, critical reagent qualification, training, and other critical support as needed. Duties include interfacing with multiple groups, independently performing tasks, interpreting results, and troubleshooting.

This role is a Wed‑Sat day shift.

• Advanced hands‑on experience with various analytical techniques including flow‑cytometry and molecular techniques, and scientific knowledge in the characterization and transfer of pharmaceutical products.
• Advanced ability to understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
• Advanced technical writing skills, problem‑solving ability, and logical thinking.
• Ability to represent the group’s interests on cross‑functional teams.
• Ability to work independently in a high‑paced team environment, meet deadlines, and prioritize work from multiple projects.
• Ability to work with local and global management.
• Advanced communication skills with peers, department management, and cross‑functional colleagues.

• Bachelor’s degree or equivalent required; preferably in science.
• Advanced degree preferred.
• 2‑4 years of relevant analytical testing or QC experience, or an equivalent combination of education and experience, preferably in a regulated environment.
• Experience with sterile cell culture, polychromatic flow‑cytometry panels, flow‑cytometry data analysis, ELISA, and qPCR preferred.

Perform testing of the QC Analytical Testing Department:

• Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
• Perform cell‑based in‑vitro flow experiments, ELISA, qPCR to assess critical reagent concentration.
• Handle complex issues and solve problems with general guidance.
• Prepare and present continuous‑improvement projects to management.
• Develop, write, and execute methods, protocols, reports, and related documents independently.
• Complete all work in a timely manner.

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 reviews within required release timelines.
• Communicate effectively with peers and demonstrate teamwork regarding results of review and required corrections.

Support document revision, project, CAPA, and investigation/deviation tasks:

• Perform assigned tasks within a CAPA, deviation, or project.
• Participate in complex projects and continuous‑improvement efforts.
• Take a leadership role, as required, for projects.
• Draft and review technical documents, such as SOPs, protocols, and reports.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Demonstrate initiative, courage, and continuous improvement throughout investigation and corrective‑action life cycles.
• Perform other tasks as assigned.

• Must distinguish colors and have vision correctable to 20/20, with an annual eye exam required.
• Must analyze numerical values daily.
• Will work in a laboratory setting up to six hours per day.
• Will work around biohazardous materials, including chemical agents (up to six hours per day).

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws.

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment…