Scientist, Investigations Team

Scientist/Investigator – Investigations Team (BMSCART, #LI-Hybrid)
Responsible for leading manufacturing and quality control investigations supporting S12 CAR‑T operations. The role requires execution of thorough root cause investigations, interviewing personnel, hypothesis testing, interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and troubleshooting complex problems. Successful candidates will interface closely with Quality Assurance teams and other functional organizations.

Monday – Friday, Hybrid Day Shift, 9 a.m. – 5 p.m.

• Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.
• Lead investigations and cross‑functional investigation teams, and close reports in a timely manner.
• Perform GEMBA walks with stakeholders to better understand process steps, and evaluate Root Cause Analysis.
• Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness.
• Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy.
• Initiate change control documentation.
• Identify functional area SMEs to perform impact assessments as part of the change management process.
• Ensure all investigations are completed in a timely manner and notify stakeholders of any delays.
• Provide technical support for manufacturing investigations / CAPAs / change controls as needed.
• Support deviation investigation defense during audits and site inspections for QC compliance related inquiries.
• Handle complex issues and solve problems with minimal guidance.
• Provide training to new investigations team members.
• Serve as author or technical reviewer of departmental procedures as appropriate.
• Support manufacturing and Quality Control testing of CAR‑T products as needed.
• Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.
• Continuously support S12, living the “patients first” mission and fostering a “Right First Time” mindset.

• Experience with deviation investigations utilizing root cause analysis tools.
• Experience in the CAPA process and ability to identify and verify effectiveness.
• Technical writing skills and ability to collaborate effectively in cross‑functional teams.
• Ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements.
• Ability to support health authority inspections.
• Knowledge of data trending and tracking, including use of statistical analysis software.
• Advanced problem‑solving ability, technical adeptness and logical thinking.
• Ability to set priorities, manage timelines and react/manage changing priorities.
• Ability to work with management (global and site) and support corporate and departmental goals.
• Excellent communication skills—honest, transparent and effective with peers and cross‑functional teams.
• Proficiency with electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system).
• Hands‑on experience with CAR‑T or biopharmaceutical manufacturing and Quality Control preferred.
• Ability to train new team members on the investigation process.

• Bachelor’s Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred). An equivalent combination of education and experience may substitute.
• Minimum 3 years in a cGMP environment.
• 1+ years of hands‑on investigation experience.
• 1+ years of hands‑on root‑cause analysis experience.

Summit West – NJ – US: $82,420 – $99,879. The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final, individual compensation will be decided based on demonstrated experience.

• Health Coverage:
  Medical, pharmacy, dental, and vision care.
• Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Programs (EAP).
• Financial…