Director, Research & Development Molecular Diagnostics
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POST DATE 8/30/2016
END DATE 12/1/2016
San Diego, CA
JOB DESCRIPTIONAPPLY An employment opportunity is currently available with Ionian Technologies, a subsidiary of Alere, at our location in San Diego, CA.
Alere has developed a novel point-of-care in vitro molecular diagnostic platform, the Alere i, based on its proprietary isothermal nucleic acid amplification technology (iNAT). The Alere i is capable of detecting a DNA or RNA target in less than fifteen minutes from a crude lysate, with exquisite sensitivity and specificity. The Alere i Influenza A & B test and Alere i Strep A test were both granted CLIA waivers, with the Influenza A & B test being the first molecular test to obtain such a status. Alere is currently looking for a senior director of research and development (R&D) to lead, manage and coordinate research and development efforts as well as product transfer efforts.
The senior director of R&D will work using established design control processes to develop and transfer new products to manufacturing. He/She will be responsible for providing technical leadership, coordinating projects, managing development teams, establishing and maintaining milestones and timelines and communicating progress to cross-functional teams across multiple sites. This position requires experience in project and team management, with an expertise in leading molecular diagnostic programs, from initial assay development through product transfer to manufacturing, in a regulatory environment. The individual must have a proven record of leading the development of molecular assays that have received FDA 510(k) clearance and/or CE mark.
SENIOR DIRECTOR OF RESEARCH & DEVELOPMENT
* Oversight of all aspects of R&D including technical leadership, project planning and management, budget and resources
* Lead integration of core technology onto new and existing multiplexing platforms, automation, and sample to answer technologies
* Facilitate efficient and effective transition of products from R&D to manufacturing, which includes coordination of all activities from feasibility to transfer
* Provide technical leadership to drive innovative solutions
* Exercise independent judgment within broadly defined practices and policies in selecting methods and techniques and evaluation criteria for obtaining results
* Effectively coordinate team to determine methods and procedures on project challenges
* Build and maintain time lines for handing off products to manufacturing
* Communicate and coordinate effectively with others outside area of expertise to accomplish project deliverables
* Develop an effective and efficient approach to managing R&D employees, through motivation and mentoring
* Ph.D. in biology, biochemistry, microbiology or a related field
* Minimum ten years of full-time experience in an industrial setting
* Extensive experience managing R&D personnel ranging from B.S. level scientists through senior Ph.D. scientists
* Hands-on R&D experience, specifically with molecular diagnostics being developed for clinical utility/commercialization, from concept through commercial launch under design controlled, phase-gated development
* Ability to forge strong, interdisciplinary teams that perform exceptionally under tight time lines and demonstrate accountability
* Hands-on product transfer experience, specifically with molecular diagnostics being transferred from R&D to manufacturing
* Experience with FDA regulatory submissions and in-depth knowledge of quality management system requirements
* Expert knowledge of scientific principles and concepts
* A broad knowledge of the technical aspects of molecular diagnostics
* Excellent analytical and troubleshooting capabilities
* Keep up to date with best practice in science
* Good communication skills, capable of communicating ideas to colleagues and customers
* Project management skills and good organizational skills
* Understanding of the commercial value of the work