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Process Engineer - United States  

Company managed [?] Still accepting applications

Posted on : 06 June 2017

Project Description

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. 
  • Our company is seeking a highly motivated individual with cell culture experience to work on innovative T cell therapy for cancer treatment.  
  • As a Process Engineer, you will provide process development and engineering support for process design and development, process characterization, and leading process improvements in GMP manufacturing. 
  • Primary responsibility will be to lead and execute lab studies to develop and characterize the manufacturing process. 
  • Experiments will be performed to identify and define Critical Process Parameters and process ranges.  
  • Additionally, you will draft and review study plans and reports, analyze and trend process data, perform Design of Experiment (DoE) , and provide technical support for engineering and process changes.  
  • You will work with the Process Science & Engineering team to design and scale-out cell therapy processes, and support process characterization, as well as draft documentation for regulatory filings to advance company's product portfolio. 

 

Responsibilities include, but are not limited to:
  • Lead and execute laboratory studies to support process design and development, characterization and process improvements 
  • Perform hands on work in a cell culture lab 
  • Write and review technical documentation 
  • Participate and report to a cross-functional development team to advance production activities 
  • Develop manufacturing processes for cell therapy products and develop process improvements and efficiencies 
  • Perform process analysis and trend process performance 
  • Design and execute process development studies to develop a thorough understanding of operating and performance parameters 
  • Act as technical expert to train and supervise process technicians 
  • Perform risk assessments 
  • Provide technical support for selection of raw materials and process materials 
  • Other duties as assigned 


Requirement
  • Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical/biotech manufacturing & process development experience required 
  • Fluency with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices 
  • Be familiar with basic cell culture lab techniques such as cell passaging, cryopreservation, formulation of media, aseptic technique using a BSC, cell counting, calculation of reagent quantities 
  • Working knowledge of scientific and engineering principles 
  • Experience in statistical analysis using JMP or Minitab 
  • Practical experience in GMP operations 
  • Document work accurately using GDP 
  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development 
  • Ability to think critically, and demonstrated troubleshooting and problem solving skills 
  • Excellent interpersonal, verbal and written communication skills 
  • Ability to function efficiently and independently in a changing environment 
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description 
  • Well-developed computer skills 
  • Pharmaceutical products GMP manufacturing experience is a must 
  • Cell culture and aseptic processing experience is a must 
  • Process modelling and simulation experience is a plus 
  • Previous experience with cell therapy products is a plus 
  • Process validation experience in a cGMP environment is a plus 
  • Process automation experience is a plus 
  • Six Sigma Green Belt or Black Belt certification is a plus 
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment 
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities