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The Senior Product Transfer Scientist (Assay Controls) will be responsible for developing new biological materials and associated production methods required for the production of these materials to be used with Cepheid Gene Xpert assays, both internally and externally. The successful candidate will have a solid understanding of basic Molecular Biology as well as Microbiology which will enable her/him to efficiently develop biological materials that will be utilized for both in-house testing as well as available for commercial sale. The position will require excellent communication skills as the person in the role will be expect to liaise with multiple other functional groups to develop the requirements for each material. This individual will develop and coordinate validation activities required for the transfer of new materials to routine manufacturing.
- Work with assay core team members to develop the requirements for controls for each assay.
- Develop a strategy for the development and production of each control required. Execute the strategy, while working with stakeholders to ensure all requirements are met.
- Develop and manage overall timeline for each project and communicate these timelines to the project teams.
- Develop and manage production scale-up, process development/optimization, technology transfer and process validation activities.
- Develop and maintain production documentation including procedures, worksheets and bills of materials.
- Maintain substantial and current knowledge of validation and process control requirements maintained by relevant regulatory bodies.
- Drive the development of new materials in a manner that ensures compatibility with manufacturing processes and capabilities.
- As appropriate, serves as a technical liaison for Development teams with respect to selection of control materials.
- Serves as a technical leader for the Product Transfer team and Manufacturing Teams with respect to control materials.
- Participate in the development of Facilities requirements, equipment requirements and manufacturing workflows for the successful transfer of production to the manufacturing team.
- Master's degree in a Life Science discipline
- Minimum of 6-10 years of relevant experience
- Detail-oriented and able to multi-task
- Ability to work within a regulated environment
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