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Senior Scientist, R&D - Assay Development

Hims & Hers· LABS
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South Plainfield, New Jersey$125k - $140kFull-timePosted 7mo ago

About the role

Senior Scientist, R&D to design, develop, validate, and implement diagnostic assays across traditional and at-home testing programs; hands-on role spanning feasibility to validation in a fast-moving, early-stage laboratory environment in Central New Jersey.

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
  • 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
  • Perform hands-on laboratory testing using specimens collected via at-home devices (e.g., Tasso, YourBio Health) across multiple 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 (Roche Cobas Pro, Sysmex) including CBC workflows
  • Support liquid handling automation workflows for high-throughput operations
  • Troubleshoot assay performance issues across immunoassay, clinical chemistry, mass spectrometry, and molecular platforms
  • Analyze experimental data and perform statistical evaluation of assay performance
  • Prepare figures, tables, and technical summaries for internal review and scientific communication
  • Contribute to peer-reviewed publications and conference presentations
  • Partner with Quality to meet CAP/CLIA and regulatory requirements
  • Support investigation of sample rejection issues and audit readiness
  • Collaborate with Clinical Laboratory Operations during assay transfer and implementation

Qualifications

  • PhD in Clinical Chemistry, Biochemistry, Analytical Chemistry, Molecular Biology, or related field with 4+ years; OR Master’s with 7+ years; OR Bachelor’s with 10+ years in diagnostic/clinical lab
  • Hands-on experience in immunoassay development (singleplex and multiplex)
  • Experience with LC-MS/MS instrumentation including sample prep and method validation
  • Experience with capillary and venous blood-based specimens
  • Experience leading assay validation and verification studies
  • Experience applying DOE and statistics to assay development
  • Ability to work independently and drive projects from concept to completion

Skills

Required:Immunoassay developmentLC-MS/MS method development and validationDOE and statistical methodologiesData analysis and reporting
Nice to have:Regulatory compliance (CAP/CLIA)

Benefits

  • Competitive salary & equity compensation for full-time roles
  • Unlimited PTO, company holidays, and quarterly mental health days
  • Comprehensive health benefits including medical, dental & vision, and parental leave
  • Employee Stock Purchase Program (ESPP)
  • 401k with employer matching
  • Offsite team retreats
Last updated Aug 12, 2026. Interested? Apply on the company site.

About Hims & Hers

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