Associate Scientist - Product Development
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POST DATE 9/15/2016
END DATE 11/4/2016
San Diego, CA
JOB DESCRIPTIONAlere 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 recently 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 creative hands-on Associate Scientist/Research Associate who will be responsible for product development and transfer work in collaboration with multiple groups and sites to transfer new molecular products to manufacturing.
The Associate Scientist/Research Associate will work within the established design control process to develop and transfer new protocols, tests and products. He/She will be responsible for development and transfer efforts. In particular, performing laboratory studies, and writing and implementing SOPs and technical reports for the feasibility, design freeze and verification of new molecular products. The position requires knowledge of scientific principles and theories and the ability to implement these scientific principles in the laboratory in creative and effective ways. The individual must have experience working under design control in a product development setting, while displaying technical proficiency. The individual will work with an integrated assay development team comprised of molecular biologists, bioengineers and manufacturing engineers to develop new diagnostics assays.
An employment opportunity is currently available with Ionian Technologies, an Alere subsidiary, at our location in San Diego, CA.
PRODUCT DEVELOPMENT Associate Scientist/Research Associate
* Perform product development efforts
* Perform product transfer efforts
* Write SOPs and study reports
* Implement experimental procedures
* Conduct test protocols, procedures, and product evaluations
* Work within the established design control process for product development and to transfer new products from R&D into manufacturing
* Work as a member of a team on product development efforts, as well as on independent development and improvement projects
* Works as part of a multi-disciplinary team with other scientists, chemists, engineers and manufacturing personnel on product transfer efforts
* Demonstrate technical proficiency in molecular techniques
* Investigate problem areas and areas of desirable product improvement
* Good communication skills, capable of communicating ideas to colleagues
* Problem-solving skills combined with analytical skills and good attention to detail
* M.S. or B.A/B.S. in biology, biochemistry, microbiology or a related field
* Minimum three years of product development and/or product transfer experience in an industrial setting
* Experience working under design control and with FDA regulatory submissions
* Understanding of the procedures, processes, record keeping, software systems and infrastructure of product development and product transfer is highly desirable
* Hands-on molecular diagnostic product development experience a plus
* Hands-on molecular diagnostic product transfer experience a plus
* Knowledge of the technical aspects of molecular diagnostics
* Excellent analytical and troubleshooting capabilities
* Ability to work as part of a team with excellent communication skills
Alere provides excellent compensation and benefits and an innovative environment. Visit our website to learn more about Alere (www.alere.com). Alere is an equal opportunity employer.