#x 9; Critically review study protocols and reports to assess quality, clearly identify gaps, and provide mitigations for technical documentation. Solve complex problems and work in a cross-functional team-based environment. Work collaboratively as part of a team while also working independently to produce data and meet challenging timelines and goals. Research, initiate and procure clinical specimens and clinical matrices for R&D projects and execute end-to-end testing until final report genera... more details
Title: Senior Scientist, R&D Operations Location: Sunnyvale, CA- 100% onsite Shift: M-F, standard working hours Pay: $50-$65/hr Overview: The Senior Scientist is responsible for on-market product support in terms of post-market activities, to evaluate the performance of products against country-specific requirements and documentation for registration that drive significant impact to the organization.
This position relies heavily on experiences gained in design and development of molecular diagnostic products and provides hands-on experiences in molecular point of care tests in an FDA-QSR and ISO13485 compliant organization.
This position is part of the R&D, Global Market Expansion group. Responsibilities:
Critically review study protocols and reports to assess quality, clearly identify gaps, and provide mitigations for technical documentation.
Solve complex problems and work in a cross-functional team-based environment.
Work collaboratively as part of a team while also working independently to produce data and meet challenging timelines and goals.
Research, initiate and procure clinical specimens and clinical matrices for R&D projects and execute end-to-end testing until final report generation.
Requirements:
Proficiency in microbiology and molecular lab techniques, with comprehensive training in blood-borne pathogen related lab safety and chemical lab safety.
Experience with designing and executing experiments with clinical specimens to verify assay performance.
Demonstrated ability to interpret federal/state/international regulations as they apply to technical documentation.
Ability to prepare high quality technical documents on product design verification and validation for regulatory submissions.
Preferred Requirements, plus not required:
Experienced in Design of Experiments, statistical tools, interpretation and reporting of results for analytical and clinical studies.
Education and Experience Requirements:
Bachelor’s degree in related field (e.g., Microbiology, Molecular Biology, Chemistry, Biology and Genetics) with 8+ years of relevant industrial experience OR
Master’s degree in related field with 5+ years of related work experience OR
Doctoral degree in related field with 3+ years of related work experience.
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