Director of Diagnostics

AltPep is seeking a highly motivated and creative scientist to help develop diagnostics and life-changing therapeutics for Alzheimer’s and other amyloid diseases. Our scientists use deep knowledge of scientific principles and concepts along with technical and analytical proficiency, thoughtful scientific creativity, dogged determination, collaboration with others, and an enthusiastic spirit to tackle these formidable, devastating diseases.

 

We are seeking a talented Director of Diagnostics to lead our diagnostics program.

 

About you:

You have experience in assay development and validation as well as experience with the regulatory process and overseeing clinical trials in the diagnostic space. You have experience with clinical design and biostatistics. You have experience in developing evidence for Analytical Validity, Clinical Validity and Clinical Utility for In Vitro Diagnostics. Ideally you will have worked on neurodegenerative diseases and the biomarkers used to track disease progression.

Principal Responsibilities

• Oversee diagnostic development, optimization, and testing
• Lead in-house analytical work and clinical validation
• Oversee CRO projects related to diagnostics
• Translate ELISA-like assays from an LDT (Lab Developed Test) to an FDA-approved Kit
• Contribute toward regulatory studies and clinical trials of diagnostic tests
• Independently design, execute, and interpret multiple studies. Design experiments to be carried out independently or as part of a collaborative team
• Be accountable for diagnostics project management, budgeting, timelines, and deliverables
• Primary point of contact with regulatory agencies during the development process
• Provide assay support for therapeutic development projects
• Supervise and mentor team members
• Coordinate with partner organizations for manufacturing / tech transfer

 

Preferred Qualifications/Experience

• Demonstrable experience in assay development and validation; experience in guiding an assay to FDA approval.
• 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 HPLC, MS, CD, functional assays)
• Experience with ELISAs, cell culture, handling human samples, chemical modifications, protein structural studies, planning animal experiments, analytical techniques, statistical analysis of results, pharmaceutical formulation, assay optimization
• Experience with quantitative diagnostics and biomarkers in a range of biological samples, including plasma and cerebrospinal fluid (CSF)
• Clinically validated assays used in clinical trials/designs

 

Education

• Ph.D in chemistry, biochemistry, pharmaceutical chemistry, bioengineering, or related field

 

 

Benefits

AltPep is a dynamic biomedical startup in Seattle that offers a competitive compensation package, including equity incentives, as well as a benefits program designed to support the well-being of our employees and their families. Benefits include medical, vision and dental coverage, and group life insurance. To learn more about us please visit www.altpep.com. 

AltPep is an equal opportunity employer with the desire for diversity of all types. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, disability, or any other status protected by federal, state, or local law. Must be authorized to work in the US.