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Qorvo Staff RandD Scientist - Molecular or Immunoassay Development - 958 in Plymouth, Minnesota

SUMMARY: Qorvo Biotechnologies is developing diagnostic point-of-care (POC) platforms with the goal of increasing the speed and accuracy of medical testing, moving healthcare closer to the patient. Qorvo combines expertise in acoustic filter technology with microfluidics and medical test system integration to POC solutions for the medical diagnostics market. Qorvo Biotechnologies is part of Qorvo s Infrastructure and Defense Products (IDP) business, which manufactures and markets high performance RF and mixed-signal integrated circuits for communications markets that connect, protect and power the world. Assay development for new business initiative within a non-medical company focused on bringing a novel Point of Care solution to the In Vitro Diagnostic (IVD) testing market with a TAM of over $5B. The Staff Scientist position has significant impact on the company's ability to launch a point of use diagnostic system. Staff Scientist will lead the effort for the pre-launch development, regulatory submission and post launch support of Qorvo Biotechnologies point of care diagnostic system. The incumbent leads problem solving activities involving molecular and/or immunoassay development, reagent manufacturing and issues with product performance. The Staff Scientist has the technical capacity to develop experimental hypotheses, design and perform experiments, analyze data sets, and write protocols and reports. Activities in this role include presenting technical aspects of assignments, leading team efforts, working effectively with all levels within the department and being responsive to project priorities. RESPONSIBILITIES: Responsible for the development of molecular and/or immunoassay IVD assays on Qorvo s PON system Develop and optimize the assays on Qorvo s biosensor platform through assay design including capture method, blocking method, reagent selection, predicate method selection, calibrator/calibration development, and assay conditions to achieve high level of assay performance Participates on multifunctional teams related to launching Qorvo s PON system. Assist in process development, product optimization, including manufacturing and QC procedures. Conducts verification and validating studies leading to regulatory submissions. Resolves manufacturing discrepancies using knowledge of the technical product details, design control and basic manufacturing and regulatory issues. Possesses strong computer skills. Can manage and analyze statistical data sets. Conducts technology transfer to manufacturing. Keeps current on standards and trends in IVD market. QUALIFICATIONS: Located in Qorvo s Plymouth, MN site. Bachelor s Degree Molecular Biology, Chemistry or related degree 10+ years of Commercial Assay Development experience or equivalent Proven skills and experience in experimental design, trouble-shooting, preparing SOPs, validation and bioanalytical reports Molecular Assay development on POC analyzers Extensive hands-on experience in isothermal amplification technologies and validation Good understanding of FDA guidance on methods for validating human IVD Experience with the following analytical systems preferred: HPLC SPR, QCM, or equivalent Nucleic acid amplification and detection Advanced data reporting and communication skills Master s degree preferred. Prefer candidate is a US citizen or a permanent resident capable of obtaining a security clearance MAKE A DIFFERENCE AT QORVO We are Qorvo. We do more than create innovative RF solutions for the mobile, defense and infrastructure markets we are a place to innovate and shape the future of wireless communications. It starts with our employees. As a unified global team, we bring a commitment to excellence, growth and a passion for creating what's next. Explore the possibilities with us. We are an Equal Employment Opportunity (EEO) / Affirmative Action employer and welcome all qualified applicants. Applicants will receive fair and impartial