Process Transfer Specialist

Job Location
5964 La Place Court #100
Carlsbad, CA 92008
Job Description

Purpose of the Position:Responsible for facilitating the transfer of products from R&D to Manufacturing consisting of evaluating design and manufacturability of the product. Essential Duties and Responsibilities:

  • Coordinate activities with Planning to balance the needs of R&D and Manufacturing while ensuring a quality product is manufactured.
  • Identify cGMP/QS training needs for the company and act as SME instructor.
  • Write and review GMP manufacturing documentation, coordinate resources and maintain a manufacturing schedule for projects in development.
  • Train Production, Manufacturing, and QC personnel on new processes.
  • Design and perform experiments to evaluate product design, streamline processes, and implement cost reductions as appropriate for new and existing products.
  • Generate new or modify existing documentation to comply with cGMP regulations.
  • Participate in troubleshooting of production problems.
  • Generate SOP’s which describe the use and maintenance of utilized laboratory equipment.
  • Remain current on FDA and ISO requirements as applicable.
  • Assist with special projects as requested and perform additional duties as required. 
Requirements

Key Qualifications & Experience Requirements: 

  • B.S. degree in Engineering, Physical, or Life Science discipline.
  • At least 5 years of related industry experience in a GMP manufacturing environment.
  • Mastery of common laboratory procedures and production methods.
  • Working knowledge of statistics, experimental design, and data analysis required.
  • Familiarity with spreadsheets, databases, and word processing computer programs.
  • Rudimentary understanding of inventory management systems and the ability to quickly learn the current ERP system. 
About Our Organization

GenMark Diagnostics is a leading provider of automated, multiplex molecular diagnostic testing systems that detect and measure DNA and RNA targets to diagnose disease and optimize patient treatment. Utilizing GenMark's proprietary eSensor® detection technology, GenMark's eSensor® XT-8 system is designed to support a broad range of molecular diagnostic tests with a compact, easy-to-use workstation and self-contained, disposable test cartridges. GenMark currently markets four tests that are FDA cleared for IVD use: Cystic Fibrosis Genotyping Test, Respiratory Viral Panel, Thrombophilia Risk Test, and Warfarin Sensitivity Test. A number of other tests, including HCV Genotyping, 2C19 Genotyping, and 3A4/3A5 Genotyping are available for research use only. For more information, visit www.genmarkdx.com.

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