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Scientific. Clinical. Software Engineering


San Jose Metro Area, CA

Job Type: Scientific Job Number: JN -052019-24870 Region: San Jose Metro Area

Job Description

  • The successful candidate should have a strong background in molecular biology, with hands-on experience designing, optimizing and validating NGS-based assays. IVD assay development experience is highly desirable.
  • The successful candidate will perform stability studies and may manage individual projects by understanding the project and provide scientific/technical direction related to stability of reagents and systems.
  • Accurately and consistently records all stability experimental data (experimental methods, materials and results) in electronic laboratory notebooks and design history files.
  • Responsible for creating / revising and implementing standard operation procedures (SOPs), laboratory records and other related documentation. Prepares and/or reviews study protocols and final summaries/reports, performs analysis and interpretation of data with conclusions/presentations, and determines future experiments.
  • Ensures testing is performed in accordance with SOPs and regulations (cGMP and GLP) for all products and operates and maintains lab equipment as required by SOPs and testing procedures.
  • May serve as primary contact for project(s) and ensures timely initiation and completion of all studies
  • Responsible for initiating, investigating, resolving, and completing event records.
  • Good interdepartmental communication skills and ability to interact effectively across groups within a fast-paced environment are required.
  • Liaise closely with Quality department and other cross-functional departmental areas to close the events and corrective actions identified during stability testing and provides timely response and follow-ups.
  • Attends project meetings, writes reports, and makes risk assessments on stability results. Presents findings or comprehensive project status reviews at internal/external seminars/meetings.
  • Contributes/authors scientific publications/manuscripts and presents at conferences/ seminars.

Who you are

You re someone who wants to influence your own development. You re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

  • B.S. or M.S. in Biological/Life Sciences, Chemistry, Biochemistry or related fields
  • 5-7 years relevant industry experience, preferred 5 years and above.
  • Direct knowledge and experience with stability studies is highly preferred.
  • NGS experience is highly preferred.
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