Associate Scientist

About the Role

The Associate Scientist/Engineer leads investigation reports in support of CAR T operations. This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and troubleshooting complex problems. The role requires close collaboration with different functional organizations, including Quality Assurance teams.

Responsibilities

• Conduct thorough investigations (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 with changes and develop appropriate mitigation strategies.
• Initiate change control documentation as needed.
• 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, and change controls.
• Support deviation investigation defense during audits and site inspections.
• Handle complex issues and solve problems with minimal guidance.
• Serve as author or technical reviewer of departmental procedures as appropriate.
• Employ lean manufacturing and Six Sigma principles to continuously improve products, processes, and systems.
• Support the "patients first" mission and foster a "Right First Time" mindset.

Requirements

• Working 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.
• Proven ability to understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
• Ability to support health authority inspections.
• Knowledge of data trending and tracking, including use of statistical analysis software (a plus).
• Advanced problem-solving ability, technical adeptness, and logical thinking.
• Ability to set priorities, manage timelines, and adapt to changing priorities.
• Ability to work with global and site management to support corporate and departmental goals.
• Strong communication skills with peers, management, and cross-functional teams.
• Experience with electronic Quality systems such as eQRMs or Infinity.
• Hands-on experience with CAR-T or biopharmaceutical manufacturing and Quality Control (preferred).

Qualifications

• Minimum Associate degree required; Bachelor’s Degree in science or engineering (preferably Biochemistry, life sciences, or related engineering discipline) preferred.
• Minimum 1 year of relevant work experience, preferably in a health authority-regulated environment.
• Previous experience in a biopharmaceutical manufacturing facility (CAR T experience a plus).
• An equivalent combination of education and experience may substitute.

Schedule

Monday–Friday (normal business hours), with flexibility to work extended hours (>8 hours/day), weekends, and/or holidays as needed to meet deadlines.

Working Conditions

• 80%–90% of time spent in an office environment.
• 10%–20% of time spent in a manufacturing and/or laboratory setting.
• Occasional travel between NJ sites for training, meetings, or corporate events.