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Associate Scientist I at Illumina, Inc. in San Diego, California

Posted in General Business 30+ days ago.

Type: Part-Time

Job Description:

This position provides technical collaboration for product development programs focused on method validation and inter/intra-laboratory analytical method transfers of enzyme activity assays used for quality release inspections prior to assembly of consumable products kits.


  • Perform late stage analytical development, qualification, validation and transfer of inspections methods for consumable products

  • Sets standards for excellence - Establishes criteria and / or work procedures to achieve a high level of quality and productivity.

  • Consistent high quality of execution across experiments of varying complexity and a broad array of techniques. Foresees issues and works to overcome obstacles to completing tasks or assignments.

  • Able to contribute in investigation and resolution of technical problems within project.

  • Develop and execute validation protocols for inspection methods used at all levels of consumable manufacturing

  • Analyze test results, draft validation/engineering reports and make technical recommendations

  • Participate in project management meetings as analytical methods validation representative determining validation requirements, as needed.

  • Learn and understand the applicable technology and engage in technical discussions.

  • Ability to work independently and within teams to make detailed observations, plan, conduct, summarize, report consistently insightful conclusions, and create recommendations.

  • Provide expert technical input with respect to method validation requirements and related Regulatory requirements

  • Ensure test method validation program meets requirements of FDA (21 CFR Part 11) and ISO

    All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.


  • At least 3-5 years of experience in analytical method development, qualification, validation and transfer

  • Minimum 2-3years of technical writing in many of the following areas: validation protocols, validation reports, SOPs, engineering/ development reports, validation master plans

  • Must be an effective communicator, able to effectively lead teams and interface well with the organization

  • Strong user level experience with many of following techniques: biochemical (enzyme) assays, binding capacity assays, UV/fluorescence spectroscopy and qPCR.

  • Expert knowledge and working application of method validation principles for regulated industries including: FDA cGMP; ICH/USP guidelines ANSI/ISO/ASQC; FMEA, Risk Analysis and Design Controls

  • Experience with statistics, Statistical Process Control and DOE techniques is desired


  • B.S./M.S. in Biochemistry, Molecular Biology, Chemistry or similar field

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