Seeking a Senior Scientist to contribute to Siemens Clinical Laboratory (SCL) and Siemens Molecular Diagnostics headquarters in Berkeley, California. This position is for a senior level scientist with diagnostics industry and/or clinical laboratory experience.
Our vision at Siemens Clinical Laboratory is to save lives by rapidly moving new in vitro diagnostic technologies and assays into clinical use.
Our mission within Siemens Clinical Laboratory R&D is to develop laboratory tests to support a new generation of therapies that will improve patient care in ways never before possible.
In order to achieve these goals, we will fully utilize decades of assay development experience and the unique resources available through our companion diagnostics development organization and global reference laboratory.
Contributions are expected at the individual level. Position reports to a Sr. Scientist or higher in the department.
• Plan and execute predevelopment and development activities, which include, but are not limited to, technology transfer, prototyping, feasibility assessment, analytical performance verification, clinical validation and regulatory submission of IVD products or testing services.
Required Knowledge/Skills, Education, and Experience
• Bachelor of Science degree in molecular biology, chemistry, or related discipline and 5 - 8 years of IVD or clinical laboratory industry experience OR an advanced degree in molecular biology, chemistry, or related discipline (an advanced degree with post-doctoral work may substitute for a portion of required working experience in the IVD or clinical laboratory industry).
• Diagnostics industry and/or clinical laboratory experience, with contributions to project planning as well as responsibility for the design and development of assays on time and within budget.
• Hands‐on experience in assay development.
• Extensive automated immunoassay development experience.
• Experience in development of molecular in‐vitro assays, in‐situ tests, and immunoassays, control system design and implementation, and 510(k) or PMA level documentation.
• Experience developing companion diagnostic assays is particularly relevant.
• Excellent communication and technical writing skills.
Desired Knowledge/Skills, Education, and Experience
• Working knowledge of the Siemens process for product development.
• Previous experience working as a member of a Product Development Core Team.
• Siemens ADVIA Centaur immunoassay platform / system experience.