Reagent Manufacturing Associate

Pattern Bioscience•Austin, TX

About The Position

Pattern Bioscience is working to combat antibiotic resistance by using AI and single-cell analysis to identify infection-causing bacteria and predict effective treatments. The company is optimizing processes and scaling consumable manufacturing output to support product development through commercialization. The Reagent Manufacturing Associate delivers reagent manufacturing and testing in an in vitro diagnostic (IVD) environment and contributes to manufacturing, validation, quality, and process-improvement activities. The role requires accurate documentation, attention to detail, problem-solving, and the ability to work independently and collaboratively in a changing environment.

Requirements

  • Associate degree in Life Sciences, Chemistry, Medical Technology, or a related field.
  • Experience pipetting in a laboratory and working in hands-on IVD manufacturing environments or other relevant process experience.
  • Proficiency in Microsoft Word and Excel.
  • Mathematical aptitude to perform and document basic calculations.
  • Hands-on HPLC experience.
  • Proficiency at pipetting.
  • Ability to adapt to a flexible and changing environment.
  • High attention to detail and ability to stay focused on repetitive tasks.
  • Drive to solve problems and apply critical thinking and analysis.
  • Ability to work independently and self-directed, as well as collaborate with others.

Nice To Haves

  • Familiarity with evaluating HPLC data.
  • Familiarity with ISO 13485:2012 and FDA Quality System requirements.
  • Familiarity with enterprise manufacturing systems.
  • Experience in reagent manufacturing and measurement methods.
  • Experience working in cleanrooms, laminar flow hoods, or BSL2 environments.
  • Experience with lyophilization.
  • Proficiency in aseptic technique.
  • Experience making McFarland standards and counting bacterial colonies.
  • Experience planning and executing experimental plans.
  • Experience with clinical microbiology.

Responsibilities

  • Deliver reagent manufacturing and testing requirements to meet demand in an IVD environment.
  • Complete process documentation and related business system transactions accurately and on time.
  • Participate in new product design transfer, stability studies, process and test method development, equipment validations, and process and test method validations.
  • Support experimental plans by adjusting equipment parameters or formulations and documenting observations and results.
  • Assist with projects targeting efficiency, scale, and quality improvements.
  • Update work instructions, standard operating procedures, and related change control.
  • Support investigations and resolution of findings identified through audits, non-conformances, key performance indicator trends, corrective/preventive actions, or escalated customer complaints.
  • Coordinate activities, solve problems, and communicate in a team environment.
  • Perform maintenance and calibration of measuring and monitoring devices.
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