Product Development Scientist
CurrentOncoMasTR is a novel prognostic assay for early stage breast cancer currently being developed by OncoMark. This multi-biomarker qPCR panel will determine the risk of recurrence for early breast cancer patients as either high or low risk. This assay will aid the clinicians to determine the best treatment options for their patients.Core responsibilities include:• In vitro diagnostic (IVD) assay development • Preparation of and adherence to technical project plans to cover all stages… Show more OncoMasTR is a novel prognostic assay for early stage breast cancer currently being developed by OncoMark. This multi-biomarker qPCR panel will determine the risk of recurrence for early breast cancer patients as either high or low risk. This assay will aid the clinicians to determine the best treatment options for their patients.Core responsibilities include:• In vitro diagnostic (IVD) assay development • Preparation of and adherence to technical project plans to cover all stages of product development (feasibility, verification, validation)• Compilation of IVDD files and associated documentation for CE-IVD products• Experience with Quality Management System (ISO 13485)• Writing and reviewing technical documents, SOPs and batch records• Implementation, validation and monitoring of manufacturing processes• Product documentation review and approval for batch release Show less