Principal Scientist, Neurodegenerative Diagnostics
- Contribute and/or lead significant components of Alzheimer's Disease diagnostic development, optimization and testing from late phase development through clinical trials.
- Assist in developing diagnostic tests for other amyloid diseases.
- Generate reference reagents and proteins
- Define quality control specifications and calibration curves
- Perform stability testing
- Strict adherence to protocols for sample management (inventory, labeling, and handling)
- Design, execute, and interpret multiple studies to be carried out by self and others
- Author and review technical reports, manufacturing documents, regulatory submissions, peer reviewed publications, Intellectual Property submissions and publications
- Motivate and support others, setting clear goals and expectations
- You may lead a project or initiative involving other contributors. You may supervise the activities of more junior personnel and be responsible for driving the development of those employees
- Desire to work in a fast, collaborative, and team-oriented environment
- Contribute to the development of a diagnostic kit meeting FDA standard
- Degree in chemistry, biochemistry, chemical, engineering, bioengineering or related field
- Ph.D. and a minimum of 8 years in industry experience.
- Deep knowledge of peptide/protein chemistry, structures, and interactions.
- Strong in analytical, organic, and physical chemistry techniques.
- Good understanding of analytical and conformational protein characterization (including LC-MS, CD, polarimetry, and functional assays)
- Experience with assay kit development
- Experience with ELISAs, cell culture, handling human samples, protein structural studies, analytical techniques, statistical analysis of results, pharmaceutical formulation, assay optimization
- Specific experience in tackling neurodegenerative diseases is a plus
- Experience working with the FDA through the regulatory process involving medical devices is a plus
- Experience working on a successfully approved diagnostics program is a plus