Assay Development Scientist

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We are seeking a Assay Development Scientist for a very important client.

Job Description
The 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.

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.
Requirement:
The ideal candidate will possess the following qualifications:

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.
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