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.
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.