The Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 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 successful incumbent must interface closely with different functional organizations, including Quality Assurance teams.
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 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.
Required Skills:
Requires a bachelor's degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).
Minimum 3 years 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.
Working experience of deviation investigations utilizing root cause analysis tools.
Working 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 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 a plus.
