An large global industrial and medical device company that designs, manufactures, and supplies radio-frequency systems and solutions for applications that drive wireless and broadband communications is seeking a Staff R&D Scientist for its new and innovative point of care diagnostic system for its Oregon R & D biotechnology location.
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 the company's point of care diagnostic system. The incumbent leads problem solving activities involving molecular assay 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.
Key Duties, Activities and Responsibilities:
- Responsible for the development of molecular IVD assays on the company's POC system
- Develop and optimize the assays on the company'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 the company's POC 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.
Work Experience, Skills and Education Required:
- 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:
- 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