Assay Development Scientist II

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Assay Development Scientist II

HemoSonics, LLC is seeking an Assay Development Scientist II to assist in the development of reagents, controls and assays for in vitro medical diagnostic devices.   

Key Attributes of the Successful Candidate:

  • Advanced training and education in a biological or medical field. Specific knowledge of coagulation biochemistry, clinical applications and in vitro diagnostics is highly desirable.
  • Must be able read and understand written and oral instructions and maintain detailed documentation.
  • Strong organizational skills and attention to detail.
  • Effective analytical, quantitative, and problem-solving skills.
  • Strong written and verbal communication skills.
  • Minimum of 1 year of experience in IVD development under design control.
  • Proficiency with Microsoft Office, particularly Word and Excel.
  • Familiarity with software for statistical analysis or design-of-experiments. 

Key Responsibilities:

  • Assay Development:
    • Develop IVD assays from concept through design transfer, including reagents and controls.
    • Develop pilot manufacturing processes. Manufacture and test development lots, including stability testing. 
    • Create and maintain development documentation, including but not limited to requirements, design descriptions, test plans test protocols, and test summary reports. Assemble, analyze and interpret test results.
    • In coordination and support of V&V, perform non-clinical assay performance testing.
    • Work with other R&D groups to integrate of assay designs with hardware and software subsystem designs.
    • Participate in developing and testing assay result calculation algorithms
    • Support clinical research activities.
    • Support concept-phase research activities.
  • Reagent and control development:
    • Work with Operations to formulate and optimize liquid based and lyophilized reagents and controls.
    • Work with Operations to develop manufacturing and quality control processes for reagents and controls.
    • Transfer reagent and control designs to manufacturing.
  • Under general supervision, plans, designs and performs development activities as assigned.
  • Suggests improvements in and adaptations to methodologies, processes, products and systems related to particular projects.
  • Prepares reports, including quantitative analysis, summaries and protocols. Participates in scientific/engineering meetings and presents technical findings.
  • Applies standard principles, theories and concepts in the field and has working knowledge of other related disciplines.
  • Tests, analyzes and interprets data and development situations/events requiring evaluation of identifiable factors.
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions to problems with broad scope and complexity.
  • Keeps abreast of technical knowledge in the field.
  • Decisions, recommendations and results cause moderate progress in project/program goals and schedules.
  • Conduct activities in compliance with laboratory safety, good laboratory practices, and design control requirements.
  • Support laboratory management and safety.

Education and Experience Required:

  • 1 year related experience with PhD in engineering, life sciences, or related discipline. 
  • 3 years’ related experience with MS in engineering, life sciences, or related discipline.
  • 5 years’ related experience with BS in engineering, life sciences, or related discipline.

Physical Requirements:

  • May involve travel to HemoSonics facilities in North Carolina and Virginia as needed
  • Must be able to lift/carry up to 50lbs.

The position is based in Durham, NC. To apply, please submit your cover letter, resume and salary requirements using our online Application Form, or via careers@hemosonics.com.

HemoSonics, LLC is an equal opportunity employer. All applicants will be considered for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Why HemoSonics?

HemoSonics is a growing team of scientists, engineers, regulatory and business professionals all focused on transforming the way clinicians manage coagulation dysfunctions by providing comprehensive, timely information on coagulation status at the point of care.

 

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