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Senior/Principal Technical Specialist, Manufacturing El Segundo United States,  

Job Score (company)

Posted on : 03 July 2017

Project Description

  • Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
  •  The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
  • We are seeking a Senior/Principal Manufacturing Technical Specialist to support a 44,000-square foot biotechnology facility that includes general laboratories for bio-processing. 
  • Under minimal supervision, this position s main accountabilities are focused on the frontline technical support of manufacturing operations while closely collaborating with the Quality and Product Sciences Unit. 

Responsibilities include, but are not limited to:
  • Provide front line technical support for manufacturing of cell therapy products 
  • Ensure successful manufacturing production runs by assessing risk, implementing preventative measures, investigating, and troubleshooting equipment and process issues 
  • Partner with Product Sciences Team to execute process development studies within commercial facility to further develop a thorough understanding of operating and performance parameters 
  • In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools  
    • Devises and implements CAPAs to address root cause and ensure effectiveness   
  • Collaborating with technical and operational stakeholders, writes and/or revises SOPs, batch records, and other operational related documents 
  • Trends key performance metrics 
  • Participates in internal audit/inspection 
  • Represents Manufacturing operations in Change Control, CAPA and Deviation meetings 
  • Conducts technical training and guidance to the cell therapy specialists 
  • Participates in the implementation of ERP systems 
  • Other tasks and duties as assigned by Management 

  • BS in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent with 10 to 15 years of experience.  Engineering degree preferred 
  • Cell culture, cell/gene therapy and/or aseptic processing experience 
  • Broad technical knowledge of cGMP compliance and experience with leading investigations, writing, deviation reports, change controls, and corrective actions 
  • Experience with investigation and root cause analysis tools 
  • Skilled at creating and delivering presentations 
  • Proficiency in using Microsoft Word, Excel, Presentation, Access, and Project 
  • Utilizes technical writing strategies to ensure content is clear and concise 
  • Possesses good communication skills 
  • Experience leading cross functional teams to obtain project deliverables 
  • Working knowledge of scientific and engineering principles 
  • Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar is a plus 
  • Knowledge of ERP systems implementation is desirable 


El Segundo CA

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