Scientist, Assay Transfer

Organization
GenMark Diagnostics
Job Location
Carlsbad, CA
Job Description

Position Summary Reach out throughout the organization and engage other departments to align and deliver results in product development in GenMark’s R&D team.  Lead development of a product transfer process. Coordinate development of QC methods and drive formulation transfer for in vitro diagnostic (IVD) products through FDA and CE mark approvals to commercialization. Initiate, direct and execute development strategies for QC method development and transferring formulations to manufacturing. Investigate, create, and develop new methods and technologies for assay QC. Integrate results with project objectives. Independently plan and design experiments; critically analyze complex data. Act as technical lead for QC method development and regularly interface with other R&D groups and manufacturing to coordinate product transfer. Maintain high level of expertise through scientific literature and competitor products. Exercise judgment within broadly defined practices and policies. May supervise junior associates in daily experiments and troubleshooting. May contribute toward or produce invention disclosures, patents and publication. Essential Duties and Responsibilities 

  • Responsible for the design, execution, and analysis of scientific experiments.
  • Responsible for carrying out work to Company standards, including documentation and accurate record keeping in order to support product development timelines.
  • Responsible for coordinating with other internal departments including manufacturing, platform development, and assay development to plan and expedite project objectives.
  • Practice industry standard good laboratory and manufacturing practices.
  • Prepares documents, including data summaries, BOMs, SOPs and Material Specifications and procedures within the document control system at GenMark Dx. Conducts directed molecular biology and biochemical tasks, including quantitative PCR amplification of target sequences, DNA quantification, analysis by gel electrophoresis, and enzymology for QC method development.
  • Analyzes and compiles experimental data and reports and records results in laboratory notebook.
  • Represents work at meetings as required, and proposes new strategies and methods to address immediate and upcoming technical or QC issues.
  • Implements the company’s health and safety policies and procedures in the functional area.
  • Provides scientific support and leadership to develop a product transfer process and assist R&D teams in completing transfer objectives for diagnostic products.
  • Ensures fact-based scientific, engineering and analytical best practices and principles are utilized to accomplish tasks.  
  • Provides an open environment and promotes teamwork across the organization. 
  • Demonstrates and advocates the Cultural Beliefs.  
Requirements
  • B.S./M.S./Ph.D. in Biochemistry, Microbiology, Molecular Biology, Analytical Chemistry or a related field. 
  • 10+/5+/0+ years of experience as a scientist in medical diagnostic product development
  • In depth knowledge and troubleshooting of applied molecular biology and biochemical assays and related instrumentation.
  • In depth knowledge of design control, risk assessment, QC method development, product specification development, and technology transfer.
  • Experience with development and transfer of IVD products is highly desired.
  • Experience with document control and inventory systems.
  • Training and experience in statistical analysis and Design of Experiments methodology and tools is highly desired.
  • Ability to understand complex scientific, engineering and business concepts.
  • Uses professional concepts to contribute to meeting the company strategic goals and to achieve personal objectives in creative and effective ways.
  • Established technical expertise; serves as a resource to other groups.
  • Possesses and applies comprehensive knowledge of a particular field of specialization to the completion of complex assignments.
  • Demonstrates competence in data analysis, research design, and the evaluation of new techniques and procedures for products, systems or technologies.
  • Excellent organizational skills, including the ability to efficiently evaluate, prioritize, and handle multiple changing projects and priorities.
  • Proven ability to lead and provide work direction to junior associates.
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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