Advanced Cell Diagnostics, Inc. (ACD) is a leader in the field of molecular pathology and tissue-based diagnostics. Our core RNAscope® technology is the world’s first multiplex fluorescent and chromogenic in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single molecule sensitivity. RNAscope® is an ideal platform for developing the next generation of tissue-based companion diagnostics. We are committed to continued innovation to bridge the gap between basic research and clinical medicine to fulfill the promise of personalized medicine.
We seek a highly creative and driven In Vitro Diagnostics (IVD) Development Scientist to join our Development team. You will work within a highly dynamic group to develop new and improved in vitro diagnostic reagents kits, molecular diagnostics assays and instruments based on our RNAscope technology
B.S in molecular biology, biochemistry, cell biology or related field with minimum of 5 years of industry experience in IVD product development or MS/PhD with minimum 2 to 3 years of industry experience
- Expertise in molecular diagnostics product design and development, design control process, product stability studies, designing and validating QC testing, and setting product, process, and material specifications
- Experience in IVD product design, transfer and manufacturing in compliance with QSR and ISO quality systems
- Experience in conducting analytical and clinical validation studies and analyzing data in support of IVD FDA 510(k)/PMA submissions and CE Mark/IVDD Technical Files/Dossiers
- Experience in conducting troubleshooting and non-conformity/CAPA investigation, supporting postmarket surveillance & customer complaints, and working with RA and QA in resolving issues with regulatory agencies
- Experience in tissue/cell-based assays such as immunohistochemistry and in situ hybridization
- Excellent computer skills including Microsoft Excel
Duties and Responsibilities
- Design, plan and execute experiments according to ACD’s Design Control process.
- Generate IVD product design validation studies and data for regulatory FDA submission and IVDD/CE Mark.
- Provide IVD product information, data summaries and other required documentation to support FDA regulatory submissions/CE Mark IVDD Technical Files.
- Develop analytical test methods for testing of intermediate components.
- Write and execute technical and verification study protocols and reports.
- Prepare design transfer manufacturing documents including DMR, SOPs, QC, specifications and templates.
- Transfer product design and validation information, SOPs, reports, training and other needed documents to Manufacturing/Operations.
- Provide technical support to manufacturing, QA, QC, RA and marketing/sales.