The Senior Product Transfer Scientist represents Manufacturing/Operation in the cross-functional core teams for Cepheid's GX assay development. This person will be the technical partner to the R&D team throughout the life cycle of new GX assay products. Daily interaction and heavy engagement with R&D, Manufacturing Engineering, Manufacturing, and other functions within Cepheid is expected of this Sr. Product Transfer Scientist.
- Actively participate in the development of new products as a representative and "voice" of Product Transfer, Manufacturing Engineering and Manufacturing to ensure compatibility with current and future manufacturing processes and capabilities.
- Partner with R&D team to assess manufacturability throughout the life cycle of new GX assay products.
- As appropriate, serve as a technical liaison for other departments with regards to production activities, including, but not limited to, incoming Inspection, reference material, reagent formulation, and product or consumables testing.
- Lead, coordinate, or participate in operations-related activities required for the transfer of new products to routine production:
o production scale-up
o process development/optimization
o technology transfer
o process validation
o test method validation
- Develop and maintain production documentation including procedures, worksheets, and bills of materials.
- Use professional skills to solve a wide range of difficult problems in imaginative and practical ways within the bounds of company policies and procedures.
- Maintain substantial and current knowledge of validation and process control requirements mandated by applicable regulatory bodies.
- Ph.D. degree in Life Science
- Minimum of 5 years of R&D or relevant experience in medical devices, biotech, and/or pharmaceutical industries
- Experience with QSR and ability to work within a regulated environment
- Detail-oriented and multi-tasking
- Ability to work effectively with cross-functional core teams
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