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Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is f... Read More
|Address||904 Caribbean Drive Sunnyvale, CA 94089 USA|
|Holding||No Holding Details|
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Product Transfer Scientist
The Product Transfer Scientist will combine knowledge of basic molecular biology, real-time PCR, fluidics, and a technical understanding of Cepheid systems to play a key role in product sustaining and support within the Product Transfer group. Lead the Manufacturing, Quality and Planning Departments in assuring the continued production of cost-effective quality products. Identify and implement streamlined and improved processes. Occasionally lead activities of junior staff.
Successfully implement assay/process/product improvements in Production, including:
o Project planning and timeline management
o Risk assessments
o Training of personnel, as required
o Implementation of all supporting documentation (BOMs, SOPs, worksheets, etc.)
o Updating design history and other documentation
* Design and execute validation/qualification activities on reagents, parts or processes.
* Coordination of multidisciplinary teams is often required.
* Act as the technical lead representing Operations in project team meetings.
* Provide coordination of Operation activities as needed to support projects.
* Provide technical support to the Manufacturing, Quality and Materials/Planning Departments which may
involve assessment of reagent formulations, process or test method development and/or troubleshooting existing product performance issues
within the organization.
* Lead investigations within production; design laboratory experiments and execute hands-on when needed, to assist in troubleshooting, process
development or improvement activities.
Required Knowledge - Skills - and Abilities:
Master's degree in Life Science or a related discipline with 6+ years of relevant professional experience. Or, Ph.D. in Life Science or a related discipline with 4+ years of relevant professional experience.
* Track record of successful project leadership and cross-functional project management in a regulated industry
* Experience working in a regulated industry such as biotechnology, medical device, etc.
* Excellent organizational and communication skills (oral and written)
* Ability to work independently and provide effective updates at executive level
* Ability to successfully lead multiple projects simultaneously towards completion within short deadlines
-Experience in real-time multiplex PCR is highly preferred
-Experience with statistical analyses of data
-Basic knowledge of costing, bills of materials and other production parameters
• Ability to work in an office, laboratory and production environment
Other Job Information
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