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Scientist

Company: PEAK Technical Staffing USA
Location: Fremont
Posted on: May 3, 2021

Job Description:


PEAK is looking for an Assay Development Scientist for a client in the East Bay, CA.


The Assay Development Scientist plays a primary role in driving the development of new diagnostic products for use in the hemostasis and coagulation clinical and home markets. You will successfully develop testing protocols which will translate to new instrumentation, consumables and reagent requirements, and support technology transfer to manufacturing. You 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.


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 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.
  • Manage lab inventory for new and existing projects. 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.


QUALIFICATIONS

  • Hands on experience in medical device, in-vitro diagnostics product development. Familiarity with the process of obtaining CE-IVD and/or FDA clearance/approval of In Vitro Diagnostic (IVD).
  • 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.
  • Applicants should minimally hold a B.S./B.A. in a life science discipline with 8+ years, M.S. with 5+ years, or a Ph.D. with 3+ years experience, preferably in medical device and in-vitro diagnostics.
  • Experience in commercial blood chemistry diagnostics, automation, and statistical evaluation of clinical data sets is highly desirable. Working knowledge of coagulation chemistries and assays a definite plus.
  • Understanding of Quality Systems Regulations and cGMP product development a plus.

Keywords: PEAK Technical Staffing USA, Fremont , Scientist, Other , Fremont, California

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