Sr. Scientist, R&D

Job ID: BP20130602-23614
Requirements:
Expertise Scientific Research & Development
Education Bachelors
Job Type Full-time
Location United States - California - Fremont
Job Level Experienced
Description:
Posting date: February 14, 2013
Position Summary:
This position is responsible for research and development of new or improved diagnostic reagent, calibrator or control products including identification and preparation of critical raw materials and formulation components; assay protocol design; assay optimization; design verification; design validation; and design transfer.
Provides technical information or resolution to product-related issues encountered by manufacturing, marketing and customer service. Involves review and interpretation of scientific literature, laboratory investigations, project planning and interaction with other departments as needed to support company goals. Works independently with little supervision.
Key Responsibilities:
Design, plan and execute experiments on all milestone tasks for new and improved products. Compile, analyze and present data. Based on the results, plan and perform next experiments to complete R&D tasks. Write reports for all milestones according to the Design Control process. Provide product and study descriptions, data summaries and analysis, and other required information to support 510(k) and other regulatory filings.
Prepare manufacturing documents including SOPs, specification sheets and worksheets. Transfer project or product information, SOPs, reports and other needed documents to Operations. If required, create and document part numbers, product structures and routes.
Work closely with project manager, perform project management function including project planning, scheduling of tasks, and communicating project status to management. Act independently to determine methods and procedures on new assignments. If needed, supervise activities of junior team members on tasks related to project completion. Perform all activities in compliance with GMP, regulatory and safety policies.
Minimum Requirements/Qualifications:
* BS/MS/PhD in a scientific discipline and minimum 8 years (BS/MS) or 5 years (PhD) of industry experience in-vitro diagnostics product development.
* 5+ years IVD industry experience
* Demonstrated expertise with product design, design control processes, product stability studies, and preparation of materials for regulatory filings.
* Demonstrated technical proficiency, scientific creativity, problem solving skills and collaboration with other departments.
* Ability to work independently on multiple projects.
* Presentation and written communication skills in a clear and concise manner are essential.
* Experienced with product design and manufacture in compliance with cGMP and ISO quality regulations.
* Advance MS Office 7.0 experience
* Experience with QSR/design control process in a regulated environment
* Experience with IVD product development including product stability determination and product optimization
* Experience with project management and adherence to timeline deliverables
* Experience in interacting with business partners/clients/customers
* Demonstrated ability for technical proficiency, scientific creativity, problem-solving skills and collaboration with other departments