Associate Scientist

Job Description

Job Summary:

• The Associate Scientist/Engineer is responsible for leading investigation reports in support of S12 CART 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 successful incumbent must interface closely with different functional organizations, including Quality Assurance teams.

Education and Experience:

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

Duties and 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 changes may have upon change implementation and develop an appropriate mitigation strategy.
• May 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.
• Notify stakeholders of any delays in a timely manner.
• Provide technical support for manufacturing investigations / CAPAs / change controls as needed.
• Support deviation investigation defense during audits and site inspections related inquiries.
• Handle complex issues and solve problems with minimal guidance.
• Serve as author or technical reviewer of departmental procedures as appropriate.
• 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.

Working Conditions:

• The incumbent will be working 80% to 90% of the time in an office environment.
• The incumbent will be working 10% to 20% of the time in a manufacturing and/or laboratory setting.
• The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
• The incumbent will need to have flexibility to work extended hours (> 8 hours/day), weekend and/or holidays when required to meet deadlines.