Director of Diagnostic Development

Seattle, WA
Jun 19, 2022
Quality, Quality Control
Required Education
Position Type
Full time

AltPep is seeking a highly motivated and experienced industry professional to help lead AltPep’s diagnostic pipeline products through the development and regulatory process.


About you:

You have experience in assay development and validation as well as experience with overseeing clinical trials and FDA regulatory process for diagnostic devices. 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 a 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 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




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



Starting at $170,000



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. 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.


Job Type: Full-time


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