Senior Assay Development Scientist

Company: Coagusense Inc.
Location: Fremont
Posted on: May 16, 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 RESPONSIBILITIES

• Develop 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.
    
    
    
    PI174252070

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