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25 days old

Research Associate: Assay Development (Menlo Park, CA)

Kelly Services
Menlo Park, CA 94025
**Research Associate: Assay Development**


**Menlo Park, CA**


**Temp to Hire**


**Pay rate: Dependent on experience**


Position Summary: We are seeking a highly motivated, talented, and driven Research Associate to join the Assay Development group in the R D division. This is a great opportunity to join a collaborative and dynamic team effort to enable development of rapid point of care diagnostic tests.


The successful candidate will assist in R D reagent manufacturing and QC test development, perform biochemical and/or molecular testing to establish specifications and guard banding for reagents and processes. You will author, review, and edit SOPs, study protocols, reports and other documentation as needed. You will work collaboratively with others in Assay Development and also with other departments, including Assay Research, Operations, Quality, and Engineering. A strong understanding of nucleic acid biochemistry and experience working on cross-functional teams is highly desired.


Specific responsibilities include, but are not limited to:


+ Follow SOPs, work instructions, and batch records to formulate intermediate reagents used in Product Development and generate records.

+ Support studies to establish quality control metrics and associated specifications for raw materials, intermediate reagents, and finished products, some of which will be manufactured by CMOs.

+ Participate in the development and qualification of test methods and records. Participate in process validation and test method validation.

+ Assist in Installation, Operational and Process Qualification of R D instrumentation.

+ Develop clear and easy-to-follow standard operating procedures SOP and forms for manufacturing transfer.

+ Contribute to product design and development, troubleshooting and process improvements.

+ Participate in and support other reagent development projects and other duties as required.

+ Work and communicate productively and cooperatively with Assay Research, Assay Development, Operations, Quality, and Engineering groups.

+ Comply with Quality Management System policies and procedures


Education/Experience


+ BS or equivalent in Molecular Biology, Biochemistry, Biomedical Engineering, Biochemical Engineering, Chemical Engineering, or a related field with 1-5 years of experience, or MS or equivalent with 1-4+ years of experience in Biotechnology or Medical Device industries.

+ Experience working with RNA extraction, quantification, reverse transcription and a variety of other laboratory techniques required.

+ Hands-on knowledge of molecular biology with an emphasis in one or more of the following areas: nucleic acid extraction, qPCR, RT-qPCR, primer design and troubleshooting.

+ Experience with isothermal amplification technologies is a plus.

+ Experience with nucleic acid extraction approaches a plus.

+ Experience working with infectious diseases or working in a BSL2 environment is a plus.

+ Excellence in data-driven process development and optimization and the ability to communicate these findings required.

+ Strong data analysis skills.

+ Familiarity with design of experiment DOE methodology a plus.

+ Working knowledge in statistical data analysis software such as MiniTab or JMP preferred.

+ Experienced in automated liquid handling workstations and related process development a plus.

+ Experienced in current Good Manufacturing Practice cGMP and 21 CFR 820 Quality System Regulation a plus.

+ Excellent written and oral communication skills.


**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: 2021-05-19 Expires: 2021-06-19

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Research Associate: Assay Development (Menlo Park, CA)

Kelly Services
Menlo Park, CA 94025

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