Job Details

  • Title: Scientist/Engineer
  • Code: RCI-43274-1
  • Location: Summit, NJ 07901
  • Posted Date: 11/24/2021
  • Duration: 6 Months
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  Job Description

Onsite Position

Summary

  • 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.