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Senior Scientist, Reagent and Assay Development

Katalyst Healthcares & Life Sciences
San Jose, CA
Closing date
Dec 1, 2021

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Job DescriptionOverview
  • Independently design experimental approaches to assess viability and feasibility of new reagents and assays
  • Prepare and oversee the preparation of technical reports, summaries, protocols, and analyses of R&D projects.
  • Maintain strong understanding of state-of-the-art science and technology development in the industry.
  • Perform data analysis and reporting of flow cytometry clinical samples across a variety of cytometry assays.
  • Provide technical expertise, leadership and support for flow cytometry operations for assay/result troubleshooting.
  • Participate in streamlining processes related to PIRs and CAPAs to reach a rapid and effective conclusion.
  • Plan/participate in the sustaining projects, lead troubleshooting and risk assessment activities.
  • Effectively coordinate with other functional areas associated with the R&D activities, including Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs, Business Development, etc.
  • Participate in interactions with regulatory agencies. Provide technical input into safety and regulatory interactions.
  • Write and review standard operating procedures and policies for the department.

  • Minimum of a Master's degree in Immunology or related biological science discipline with at least 3 years of proven experience or Ph.D. with at least some relevant industry experience.
  • Experience with sample prep and experiment design for multi-parameter flow cytometry applications.
  • Experience training bench-level personnel and leading projects.
  • Extensive hands-on experience operating and troubleshooting flow cytometers.
  • Minimum of 5 years' related experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment is desired but not required
  • Experience in IVD product development is desired but not required.
  • Experience in regulatory submissions and/or interactions with regulatory agencies is desired but not required
  • Knowledge of clinical and/or research laboratory environment and quality control procedures is preferred.
  • Knowledge of design of experimental procedures and literature search for targeted information.
  • Knowledge of biostatistical methods and data analysis experience
  • Current knowledge of flow cytometry and immunology and cell-based assays.
  • Excellent listening, written, and oral communication skills.
  • Strong learning agility.
  • Self-motivated with a strong sense of urgency and willing to take hands-on work.
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