Scientist

POSITION DESCRIPTION

We seek an In Vitro Diagnostics (IVD) Development Scientist who integrates rigorous scientific principles, actionable innovative ideas and a passion to drive advancement of clinical diagnostics to join our Development team. You will work within a highly dynamic group in collaboration with multiple disciplines to develop novel in vitro diagnostics assays based on our RNAscope technology.

Customer Relationship
Personal Evolution
Autonomy
Administrative Work
Technical Expertise

KEY RESPONSIBILITIES:

  • Lead assay optimization and product development activities for clinical applications of RNAscope.
  • Design, execute and analyze investigational experiments and product development studies, individually or as part of a small team.
  • Develop and validate test methods to assess materials and processes.
  • Draft study protocols and reports to support regulatory submissions.
  • Transfer product design to Manufacturing and Operations through specifications, SOPs, and training.
  • Identify potential product and process improvement
  • Support Quality Control through technical investigations.
  • Contribute to product and process risk assessments.
  • May supervise one or more Research Associates, as assigned.

QUALIFICATIONS:

  • Ph.D. in molecular biology, biochemistry, cell biology or related field (BS or MS with minimum of 5 years of industry experience.)
  • Track record of successful molecular assay development and optimization.
  • Excellent analytical and problem-solving skills.
  • Ability to write accurate, concise technical documents, including study reports and procedures.
  • Ability to present clearly and effectively to technical and non-technical audiences.
  • Commitment to the interdisciplinary nature of product development and process control.

PREFERRED QUALIFICATIONS:

  • Expertise in analyzing histology and tissue-based assays such as immunohistochemistry and in situ hybridization.
  • Strong understanding of the fundamental principles of nucleic acid-based hybridization assays.
  • Experience in IVD, medical device or pharmaceutical development under a Quality System.
  • Experience conducting analytical or clinical validation studies in support of regulatory submissions.
  • Quality Control and/or Manufacturing experience is a plus.
  • Strong scientific writing abilities.
  • Bioconjugation experience.

Where permitted by applicable law, candidate must have received or be willing to receive an FDA authorized COVID-19 vaccine by date of hire to be considered for this position.