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29 days old

Sr. Assay Development Scientist

Kelly Services
Fremont, CA 94536
**Title: Sr. Assay Development Scientist or Principal Scientist (exceptional candidates)**


**Work Type: Direct Hire, On-Site (M-F)**


**Location: Fremont, CA**


**Job Summary:**

The Sr. Assay Development Scientist is a key member of the 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 4-6+ 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


**_If you, or someone you know, would like to be considered please apply online today to discuss next steps._**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-05-30 Expires: 2022-06-30

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Sr. Assay Development Scientist

Kelly Services
Fremont, CA 94536

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