South San Francisco, CA

Production Assay Scientist

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Position Description

The Production Assay Scientist is an enthusiastic, self-motivated individual with great communication skills who can support the Manufacturing, Clinical Laboratory, and Service Engineering groups by working to continuously monitor and improve first pass assay yield for all of our Production grade assays. As a Production Assay Scientist at Counsyl, you will use your deep knowledge of molecular biology and next generation sequencing to actively monitor the health of each one of our production grade assays, and work with multiple groups to implement modifications to the workflow that will improve assay quality. You will be heavily involved in the day to day monitoring of the production assays, as well as ensuring that Counsyl maintains and improves upon our high standards of delivering quality results to our patients in a timely manner, by continuously working to implement both scientific and process based improvements to our current assays and systems.

The Production Assay Scientist will demonstrate a high level of individual responsibility and accountability and possess the ability to perform to the requirements listed below. The candidate will be comfortable performing root cause analyses in a clinical genomics setting, as well as devising and executing scientific experiments to generate data, draw insightful inferences, and implement process improvements.

What you'll do

  • Work to develop and maintain a deep understanding of the molecular biology, automation, and sequencing methods that are integral to each Counsyl assay.
  • Work to maintain impeccable first pass yield across all production level assays.
  • Serve as the first line of defense for any production assay performance issues.
  • Design and perform preliminary experiments to confirm or refute hypotheses relating to the root cause of assay performance issues, with the overall goal of taking effective corrective action when needed.
  • Work with the Data Analytics Team to generate and refine informative dashboards that accurately reflect the health of each production grade assay.
  • Monitor all assay health related dashboards on a daily basis and report on trends during weekly lab quality meetings.
  • Attend daily GEMBA walks on the production line.
  • Assist with the transition of new assays into a production setting.
  • Assist with the development and implementation of process improvements that raise first pass yield and improve efficiency of the laboratory.
  • Design and perform process characterization experiments for production assays.
  • Design and perform reagent characterization experiments for each of our production grade reagents.

About you

  • Hold one of the following degrees, + years of experience:
  • Ph.D. in Molecular Biology, Genetics, Bioengineering or related field, preferred
  • M.S. in Molecular Biology, Genetics, Bioengineering or related field +5 years of work experience in a clinical laboratory or similar work environment will also be considered

  • You can pull apart and identify the critical components of production workflows at a glance.
  • Experience in CLIA regulated clinical labs / Biotech start-up/ fast growth company or similar working environment will be very helpful
  • Advanced degrees will be favored

  • You are well versed in at least two of the following areas, while possessing the ability to rapidly become competent in all of the others:
  • Next generation sequencing, preferred
  • Method development for liquid handling, preferred
  • Molecular biology
  • Ability to deduce key insights from data and metrics
  • The ability to draw from historical knowledge to suggest additional metrics that would help the laboratory develop key insights on the improvements that need to be made for gains in TAT, Assay quality, COGS reduction, etc
  • Experience with writing basic scripts for data analysis
  • Experience with lean manufacturing

Interview process

Counsyl is driven by some of the brightest people in the industry. Our interview process is geared to ensure that we continue to hire the very best. We are an equal opportunity employer and value diversity at our company.

Our interview process is composed of practical and situational interviews in a series of settings spanning Skype, practical exams, and in-person meetings. Our goal is to gauge both your ability to succeed in the first 90 days as well as your capacity to scale with us as we grow.

Why Counsyl?

Throughout it all, we are looking to understand why you are driven to be a part of our company. Specifically, we want to know how you identify with our mission and will contribute to our team.