Employee is responsible for assay development being done under an agreement with the Department of Defense (DoD). This entails three development teams that will develop assays that run on Cepheid's existing GeneXpert platform as well as the Omni system that is still in development. The Senior Director provides both indirect and direct guidance as needed to technical leads and teams, functions as the R&D point person for interactions with the DoD, and works closely with cross-functional leadership to ensure co-development of the assays, system, and software are integrated to meet performance requirements and timelines.
Oversee three or more development managers who each lead technical teams to develop IVD products following Cepheid's Design Control guidelines that meet CE-IVD, FDA 510(k) or PMA, and other regulatory agency requirements.
Manage Assay Development R&D staff, including hiring, training, performance management and development.
Ensure that project teams meet QSR Design Control requirements, as well as other international standards, such as ISO compliance and GLP/GMP requirements.
Participate in strategic planning for assay development projects and develop departmental plans and budgets to ensure resourcing consistent with business decisions.
Formulate and recommend policies, objectives, plans, procedures and schedules for assay development.
Provide technical and managerial support to other cross-functional assay development R&D teams within a matrix environment.
Requirements Education or Experience
Bachelor's degree with 14 years of experience OR Master's/Doctoral degree with 12 years of experience AND 4 years managing people
Demonstrated experience in leading project teams from project initiation through launch.
Demonstrated ability to successfully lead teams across both "R" (research to develop core technologies or identify relevant biomarkers) and "D" (product commercialization) phases of development.
Knowledge and Skills
Comprehensive understanding of concepts of IVD development, including demonstrated experience in full IVD development process.
Assay development experience utilizing PCR, qPCR, RT-qPCR and/or alternative amplification methods, general knowledge of nucleic acids and enzymes, and expert with nucleic acid sample preparation methods.
Strong experience with lab documentation and reporting and statistical methods for experiment design.
Effective written and oral communication skills, presenting within the company on project and departmental topics and externally on product topics.
Ability to lead and manage staff and technical leads through organization and project change.
Ability to collaborate externally and internally with peers and leaders within Cepheid to ensure effective cooperation and collaboration between functions.