Director, Global Assay Innovations

The Director, Global Assay Innovations, based in our Solna, Sweden R&D location, will lead independent technical teams in support of Innovation Core & Research projects primarily focused on real-time PCR and RT-PCR assay innovation & research in an FDA-QSR and ISO 13485 compliant organization. Projects will include prototype assay, consumable, and instrument components/systems for early-stage in vitro diagnostic R&D activities across multiple global Cepheid R&D sites. The ideal candidate will have expertise in molecular biology, microbiology, virology, or a related biological/biomedical background including aspects such as molecular assay design, sample preparation, and chemistry. The candidate should be extremely proactive with a curious attitude and able to thrive in the face of ambiguity; an innate systems-level thought process for coordinating a large number of technically varying initiatives is key.
As a Director, it is expected that you work hands-on from time-to-time as well as providing technical and project guidance in the role of technical lead for innovation projects. The incumbent of this role will work closely with cross-functional teams to execute project tasks consistent with project timelines and deliverables. The Director position requires the ability to lead more complex projects in terms of technical difficulty, and the need to combine input from multiple functions (core chemistry, systems, and software) to resolve technical issues. Additional key responsibilities include working with external collaborators, seeking and supporting external funding, and in some case driving external collaboration projects which may include early-stage clinical/field studies. The ideal candidate will lead, energize, and engage individuals to achieve personal development and business goals; proactively cultivates and retains talent by providing challenging or "stretch" assignments to develop individuals and the team as a whole.
In addition to technical qualifications, the ideal candidate will be highly goal-oriented and organized and be able to thrive in an atmosphere of shifting demands and priorities. As a manager and leader, ownership of entire research projects is expected. The candidate should possess excellent oral and written communication skills, and the ability to create followership and work in a cross-functional team-based environment (incl. Innovation, Engineering, Systems Integration, and other groups) as well as with outside collaborators is a must.
ESSENTIAL JOB RESPONSIBILITIES:
Oversee technical innovation teams to develop core technologies to support new products or technologies towards new IVD test within CE-IVD, FDA 510(k) or PMA, and other regulatory agency requirements.
Conceive, design, and optimize real time PCR and RT-PCR assays, including sample preparation, based on early-stage requirements.
Serve as project technical lead and innovation representative on a multi-functional project core teams through all early phases of projects; product and project definition, research to develop assays to the prototype stage, and early-stage verification and validation studies internally and externally.
Ensure that laboratory staff follows quality, documentation, laboratory, and safety requirements.
Ensure that project teams meet QSR Design Control requirements as needed, as well as other international standards, such as ISO compliance and GLP/GMP requirements.
Directly manage teams across multiple R&D sites, including hiring, training, performance management and development.
Contribute technical data and advise in formulation of departmental plans, strategies and budgets to ensure resourcing consistent with business decisions.
Adapt and implement policies, plans, procedures and schedules.
Interact with other Cepheid R&D teams and/or external collaborators to solve cross-functional problems and leverage knowledge and capabilities.
Perform lab and office administrative tasks, including lab organization, equipment and materials acquisition/purchase, and experimental reports/presentations.



Education or Experience (in years):
Bachelor’s degree with 12+ years of experience OR
Master’s/Doctoral degree with 8+ years of experience
5+ years managing people



Knowledge and skills:
Experience leading or managing technical teams as evidenced by team, project or collaborations management.
Ability to lead and manage technical staff and core teams to adopt sound development decisions and conform to required business changes.
Ability to collaborate with and influence peers and leaders within innovation and R&D to leverage experience across projects.
Innovative, out-of-the-box problem solver capable of overcoming challenging and complex issues in a fast-paced environment.
Ability to work with external collaborators including pursuing outside funding grants and driving external clinical studies.
Exposure to and understanding of concepts of IVD product development, including demonstrated experience in assay optimization to establish technical feasibility as well as downstream product verification and validation activities.
Participation in the successful launch of an IVD commercial application preferred.
Detail oriented, proactive, and driven
Effective written and oral communication skills, presenting within the department, core team and to business leadership on project and departmental topics. External presentations on product and project topics is expected.
Assay development experience utilizing PCR, qPCR, RT-qPCR, general knowledge of nucleic acids and enzymes, and experienced with relevant sample preparation methods.
Effectively leverage scientific literature, databases and patents to design new assay technologies and approaches that enable improved or new functionalities
Propose new research projects and technologies that enable Cepheid to realize its strategic vision in the areas of infectious disease, oncology, and genetics
Must possess skills/knowledge in handling clinical samples and be able to work in a BSL-2 environment.
Experience with lab documentation and reporting and statistical methods for experiment design, including proficiency in the use of Minitab or JMP for data analysis and presentation.
Experience with design of experiments (DOE) methods.
Proficiency with standard Microsoft computer programs.
Experiences using bioinformatics tools and oligo design tools (e.g., BLAST, Visual OMP) a plus.