Associate Scientist

February 11, 2019 | San Diego, CA (USA) | Research & Development

Scope:  Contributes knowledge of IVD lateral flow product development and expertise to ongoing research and development and/or development activities of new lateral flow project proposals. Familiarity with PCR and other lateral flow technologies. Experience with IVD testing instrumentation for moderate complexity to CLIA waived devices from feasibility to verification. Independently designs, executes and interpret complex experiments and analytical procedures to address specific R&D related scientific objectives. Understanding of FDA 510k process, experience in writing Analytical study protocols and reports, QSR design control, experience in writing, submitting and post-submission FDA Q&A for 510k. 

Responsibilities:

May perform some or all of the following: 

Under supervision, performs analytical procedures and implements new techniques for lateral flow product development

Contributes to scientific literature, external conferences and/or scientific patents where applicable.

Provides consultation within and among internal groups.
Interpret and report results in oral and written formats, both within and outside the department.

Work simultaneously on several aspects of a project or multiple projects. 

Education / Experience:

BS (Chemistry/Biology) with 2-5 years’ experience.  IVD experience is a preferred.

Expertise in PCR assay development.

Understanding basic function of IVD product development under Design control

Familiar with Quality Systems and QSR compliance for documentation

Experience in 510(k) writing, submission, Q&A process

Knowledge of CLSI experimentation study protocols. 

Skills / Pre-requisites:

Strong investigative or technological orientation with independence of experimental design

Proven track record of accomplishments in IVD lateral flow product development

Understanding of Statistical software packages Minitab or SAS JMP a plus

Prior knowledge of instrumentation a plus

Good work ethic, team player

Presentation, written and oral communication skills. 

Training:

Company policies and Standard Operating Procedures as defined by QA system at the relevant Sekisui Diagnostics site.
Six Sigma training  (a plus)

NA

 

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