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Project Manager (Sorrento Valley)
By | September 30, 2009
InVivoScribe Technologies, Inc., a highly profitable, rapidly growing in vitro diagnostics company located in beautiful San Diego, California is celebrating its 15th year in business. We are interested in identifying exceptional, highly motivated candidates for two full-time positions as Project Managers.
Job Summary:
Direct the design, development, validation, and the preparation of submission materials for regulatory clearance or approval of quantitative and qualitative molecular diagnostic tests utilizing PCR-based methodologies.
Job Responsibilities:
Manage a team to design and develop new and improved products for the molecular diagnostics market utilizing FDA and ISO requirements for design control.
Conduct development studies in support of FDA submissions. Organize, write and maintain standard research documentation and compile project specific reports.
Interact with FDA on technical issues.
Participate and present in research related conferences.
Effectively identify, initiate and coordinate resource planning for new projects, research approaches and/or scientific opportunities.
Identify development opportunities that can augment our positive revenue stream.
Participate in development and prosecution of intellectual property, when applicable.
Requirements:
This position requires an MD and/or PhD in Molecular Biology, Biochemistry, Immunology, or closely related field, with 5-10 years experience in a research and/or development environment. Equivalent combination of education, experience and/or outstanding performance for exceptional applicants with demonstrated capabilities will be considered. Must have commercial experience developing and validating quantitative real-time PCR assays.
Requires hands-on experience with advanced molecular biology and biochemistry of nucleic acids. (i.e., DNA enzymology and new technology development).
Includes an extensive and comprehensive understanding and experience with advanced molecular biology and molecular diagnostic techniques and technologies.
Experience with preparation of data for 510(k), PMA and CE submissions.
Expertise in DOE and statistical data analysis tools
Additional knowledge in hematology, immunology, or virology a plus.
Direct working knowledge with medical device quality and regulatory requirements including QSR, ISO and EN quality system standards and the IVD Directive.
Ability to consistently meet critical deadlines.
Ability to work in a team environment.
Please contact us by email at: careers@invivoscribe.com or by facsimile at: (858) 623-8109.
InVivoScribe Technologies, Inc.
6330 Nancy Ridge Drive, Ste 106
San Diego, California 92121-3230
Salary: Commensurate with experience
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