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US-: Molecular Biology Diagnostics

Date: 29-Nov-2011
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Group Leader – Molecular Biology Diagnostics


* Develop, optimize and implement molecular diagnostic assays using next generation sequencing * Lead an assay development group to complete activities in a timely manner and in compliance with the documentation and quality policies * Solve problems of diverse scope where experimental setup requires DOEs (Design of Experiment) and where analysis of data requires computational capabilities and appropriate statistic software knowledge * Lead projects requiring collaborations with other personnel within and outside the department, and with external partners * Prepare technical reports, summaries, protocols and quantitative analysis for general documentations, assay/ product transfers to a diagnostics development team * Report and present study data in department and project meetings

Job Requirements

* PhD in Molecular Biology/Biochemistry, or a closely related field, with at least six years of industry experience, including at least four years of experience in molecular diagnostics * At least two years of supervisory experience in group setting with responsibilities of direct reports’ career development plan and performance reviews * Proven track record of innovation and implementation beyond proof of concept stage * Extensive knowledge of molecular diagnostic assays and their detection technologies. Relevant technologies include but are not limited to: microarray analysis, qPCR and DNA sequencing * Expertise in DOE and statistical data analysis tools like Minitab or JMP, Programming skills in R are high preferred * Working knowledge and experience of design control, quality system and risk assessment * Experience with assay/test development/submission and documentation for 510k or IVD a plus

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BioTech FYI Center