- Title: Scientist/Engineer
- Code: RCI-43274-1
- Location: Summit, NJ 07901
- Posted Date: 11/24/2021
- Duration: 6 Months
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- Name:Sumit Rawat
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 232
- 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.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- 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.
- Demonstrate advanced problem-solving ability / mentality, technical adeptness and logical thinking.
- Ability to set priorities, manage timelines and effectively react/manage changing priorities.
- Ability to work with management (global and site) and support corporate and departmental goals.
- Ability to communicate honestly, transparently and effectively with peers, department management and cross functional peers.
- Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system).
- Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control.
- Ability to train new team members on the investigation process
Education and Experience:
- 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.
DUTIES AND RESPONSIBILITIES:
- 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.
- 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.