Senior Assay Development Scientist

Company: Coagusense Inc.
Location: Fremont
Posted on: January 15, 2022

Job Description:

SUMMARY The Sr. Assay Development Scientist is a key member of the CoaguSense R&D Team and plays a primary role in driving the development of new diagnostic products for use in the hemostasis and coagulation clinical and home markets. S/he will successfully develop testing protocols which will translate to new instrumentation, consumables and reagent requirements, and support technology transfer to manufacturing. S/he will lead R&D projects and work collaboratively with other R&D teams (both internal and external), product marketing, manufacturing, and technical collaborators to take new assay products and applications through concept, feasibility, development, validation, and commercialization. ESSENTIAL DUTIES AND RESPONSIBILITIESDevelop new diagnostic assays and enhance current methodologies used to study hemostasis and coagulation therapies in a clinical and Point of Care (POC) setting.Translate market sector requirements into the creation of new coagulation-based assays, instrumentation, and testing methodologies.Interact cross-functionally to define products, transfer new designs to manufacturing, and ensure on-time regulatory submissions. Work with R&D collaborators to generate performance qualification, method comparisons, and validation reports. Facilitate with peers and external collaborators for optimization of all aspects of the development processes for increased efficiency and effectiveness.Conduct experimental designs in an organized and methodical fashion. Execute research and development activities through all phases of product development. Plan, design and execute various scientific investigations to support enhancements to existing assays and align with company goals.Conduct validation tests for new assays, instrumentation and methodologies and support clinical trials as needed.Support assay transfer to manufacturing operations and insure successful commercialization of new assay products.Manage project deliverables to ensure timely project delivery. Set clear product development timelines and prioritize efforts to deliver on commitments.Work in the lab, design and execute studies, and perform troubleshooting. Resolve technical and workflow issues in a timely fashion.Lab manager for new and existing projects, oversee junior R&D staff members and train new employees.Record and document assay development work in the scientific notebooks for reference purposes.Ensure all research and development studies adhere to company and ISO13485/FDA guidelines.Generate reports pertaining to assay development progress and contribute to new IP as needed.This position will act as a resident expert for assays in development and responsible for project lifecycle deliverables.QUALIFICATIONS Ph.D. with 6+ years' experience directly in medical device and in-vitro diagnostics assay development is required. Successful applicants should hold a degree in a life science discipline (Chemistry, Biochemistry, Biophysics, Molecular Biology, Bioengineering or closely related disciplines).Hands on experience and demonstrated track record in medical device, in-vitro diagnostics assay development. Familiarity with the process of obtaining CE-IVD and/or FDA 510K clearance/approval of In-Vitro Diagnostic (IVD) assay products. Experience in commercial blood chemistry diagnostics, quantitative assay development, consumables design, reagents development, and statistical evaluation of clinical data sets is required. Working knowledge of coagulation chemistries and assays (PT/INR, ACT, aPTT, Fibrinogen) is highly desired.Excellent organization, time-management, record-keeping, interpersonal and communication skills are essential. A self-motivated individual that is detail-oriented, excels at problem solving and can function both independently as well as part of a team is required. Must be able to work and contribute to a highly collaborative and fluid environment on multiple projects concurrently. Understanding of Quality Systems Regulations, ISO13485 and cGMP product development is required. PI160605284

Keywords: Coagusense Inc., Fremont , Senior Assay Development Scientist, Other , Fremont, California