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Product Development Scientist/Senior Product Development Scientist Job Details

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Job Ref:  PRODEV
Job Type:  Full Time
State:  California (CA)
City:  Irvine
Post Code:  Jan 23, 2012
Job Description:  The Product Development Scientist will support the development of molecular diagnostic oncology tests to be offered in our CLIA laboratory. In this hands-on position, the Scientist will be responsible for: 1). Development of molecular diagnostic qPCR assays 2). Ensuring the successful transfer and validation of the tests in the CLIA lab. 3.) The successful candidate must be able to work effectively across functional disciplines, under tight deadlines with minimal supervision.


-Design and develop molecular diagnostic assays under Design Controls from late stage feasibility through test launch. Identify all issues critical to successful test development and manufacture


-Evaluate suppliers of equipment, materials and reagents for suitability in product
development and assay component manufacturing


-Apply knowledge of molecular biology and oncology to evaluate and create new methods and procedures as needed


-Perform lab work according to internal quality standards, document accurately the results and archive them accordingly in order to facilitate downstream work (intellectual property, regulatory affairs or research follow-ups)


-Analyze results using statistical methods, control for consistency with previous work, summarize and communicate main outcomes to team members



-Prepare experimental plans and protocols, technical reports, summaries, and quantitative analyses that accurately and clearly communicate necessary information.



-Drive creation of all necessary documentation to support test manufacture, including manufacturing specifications, QC test procedures, raw material specifications and validation protocols.



-Effectively drive transfer and validation of new tests into the clinical laboratory


-Utilize independent project management and cross-functional teamwork skills to ensure
timely and reliable results

Requirements

1.Advanced degree (Ph.D. or M.S.) in molecular biology or related discipline
2. A strong foundational knowledge of molecular biology
3.At least 5 years' experience in advanced molecular assay development, especially qPCR
4.IVD Industryexperience with proven history of delivering commercially successful results
and working under Design Controls.
5.Strong problem solving and bench scientist skills and ability to work independently
6.Strong written and verbal communication skills required

01/24/2012
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