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About the Role Hims & Hers is seeking a Senior Scientist, R&D to join our growing laboratory organization. The role is an individual contributor reporting to the Director of R&D and focuses on developing and validating diagnostic assays for both traditional and at-home testing programs, as well as supporting assay implementation into clinical operations. This on‑site laboratory position is based in Central New Jersey. You Will Assay Development and Validation Design and execute immunoassay development, optimization, and verification studies including ELISA, chemiluminescent, and multiplex formats. Perform method validation experiments such as precision, accuracy, linearity, interference, and stability testing per established protocols. Apply Design of Experiments (DOE) and statistical methodologies to assay optimization and troubleshooting. Support LC‑MS/MS method development and validation for clinical chemistry and hormone analytes. 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. Laboratory Execution 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, covering CBC and whole blood analyte workflows. Support liquid handling automation workflows for sample processing and high‑throughput laboratory operations. Troubleshoot assay performance issues across immunoassay, clinical chemistry, mass spectrometry, and molecular diagnostic platforms. Data Analysis 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. Quality and Regulatory Collaboration 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. You Have 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. Experience applying DOE and statistical methodologies to assay development and optimization. Proven ability to work independently and drive projects from concept to completion. Preferred Experience in a CAP and/or CLIA regulated laboratory environment. Experience with at‑home or point‑of‑care diagnostic testing programs. Experience with dried blood spot (DBS) workflows and stability characterization. Familiarity with emerging biomarker categories. #J-18808-Ljbffr
Senior Scientist, R&D - Assay Development • South Plainfield, NJ, United States
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