Senior Scientist, R&D - Assay Development
About the role
Hims & Hers is seeking a Senior Scientist, R&D to join our growing laboratory organization. This individual contributor will report to the Director of R&D and work closely to develop and validate diagnostic assays supporting both traditional and at-home testing programs, and support assay implementation into clinical operations.
Responsibilities
Design and execute immunoassay development, optimization, and verification studies including ELISA, chemiluminescent, and multiplex formats
Perform method validation experiments including precision, accuracy, linearity, interference, and stability testing per established protocols
Apply Design of Experiments (DOE) and statistical methodologies to assay optimization and troubleshooting
Evaluate performance characteristics of capillary versus venous specimens, investigate interference, and develop strategies to extend sample stability
Develop and revise SOPs to support consistent, reproducible laboratory operations
Prepare validation summaries, protocols, and technical reports in compliance with quality and regulatory standards
Perform hands-on laboratory testing using specimens collected via at-home devices such as Tasso and YourBio Health, including whole blood, plasma, serum, and other biological matrices
Operate LC-MS/MS instrumentation (SCIEX 4500MD or equivalent) including sample preparation, method validation, and data review
Support testing on automated chemistry and hematology platforms including Roche Cobas Pro and Sysmex systems, including CBC and whole blood analyte workflows
Troubleshoot assay performance issues across immunoassay, clinical chemistry, mass spectrometry, and molecular diagnostic platforms
Analyze experimental data and perform statistical evaluation of assay performance including precision, bias, and total allowable error modeling
Prepare figures, tables, and technical summaries for internal review and scientific communication
Contribute to peer-reviewed publications and scientific conference presentations
Partner with the Quality team to ensure study designs and documentation meet CAP, CLIA, and applicable regulatory requirements
Support investigation and resolution of sample rejection issues to improve overall laboratory quality metrics
Support laboratory inspection readiness and audit preparation activities
Collaborate with Clinical Laboratory Operations during assay transfer and implementation
Requirements
PhD in Clinical Chemistry, Biochemistry, Analytical Chemistry, Molecular Biology, or related field with 4+ years; OR Master’s degree with 7+ years; OR Bachelor’s degree with 10+ years of relevant bench experience in a diagnostic or clinical laboratory setting
Demonstrated hands-on experience in immunoassay development including singleplex and multiplex formats
Experience with LC-MS/MS instrumentation including sample preparation and method validation
Experience with capillary and venous blood-based specimen types
Demonstrated experience leading assay validation and verification studies
Proven ability to work independently and drive projects from concept to completion
Preferred Experience
Experience in a CAP and/or CLIA regulated laboratory environment
Experience with at-home or point-of-care diagnostic testing programs
Familiarity with emerging biomarker categories relevant to metabolic health, longevity, and consumer wellness testing
Experience with NGS-based workflows including library preparation and bioinformatics data review