Company Overview
AvantGen is a San Diego–based company developing novel antibodies for therapeutic and diagnostic applications. We are seeking a hands-on immunoassay scientist to lead assay optimization, analytical validation, and configuration of our assays into reproducible, manufacturable kits. This is a bench-based role for someone who has taken antibody-based assays from prototype through validation and into production, and who wants ownership of a novel platform from feasibility to product.
Job Summary
We are seeking a highly skilled Scientist or Senior Scientist specializing in Immunoassay development and kit manufacturing, with expertise in ELISA (Enzyme-Linked Immunosorbent Assay) and CLIA (Chemiluminescent Immunoassay) platforms. This role involves leading the design, optimization, and validation of immunoassays for diagnostic kit production. The successful candidate will play a pivotal role in advancing our products by ensuring assay robustness, reproducibility, and compliance with quality standards. This position offers an exciting opportunity to contribute to cutting-edge diagnostic solutions that impact global health.
Duties
- Develop and optimize sandwich/noncompetitive immunoassays (ELISA and chemiluminescent formats) using antibody pairs, including capture/detection titration, buffer and blocking optimization, and read conditions
- Apply design-of-experiments (DOE) approaches to maximize low-end sensitivity and signal-to-background
- Perform antibody labeling/conjugation (e.g., acridinium, HRP, biotin) and evaluate plate- and paramagnetic-bead–based formats
- Execute analytical validation per CLSI guidelines — sensitivity (EP17: LoB/LoD/LLoQ), precision (EP05), linearity (EP06), and interference/specificity (EP07)
- Formulate and value-assign calibrators and controls; design and execute reagent stability studies (real-time and accelerated)
- Configure the assay into a prototype kit (reagents, calibrators, controls, protocol) and establish lot-to-lot reproducibility
- Develop and document manufacturing processes, transfer assays to production, and support scale-up and QC of reagent lots
- Maintain rigorous documentation (SOPs, batch records, validation reports); contribute to grant reports and Phase II planning
Requirements
- BS/MS with 5+ years, or PhD with 2+ years, of hands-on immunoassay development experience (ELISA and/or chemiluminescent/CLIA formats)
- Demonstrated track record taking an immunoassay from development through analytical validation
- Direct experience configuring and manufacturing diagnostic/immunoassay kits, reagent formulation, calibrator/control preparation, and lot-to-lot QC
- Working knowledge of assay performance characterization and CLSI EP validation protocols
- Strong troubleshooting skills and meticulous documentation habits
Preferred qualifications
- Experience developing low-abundance analyte immunoassays
- Antibody conjugation/labeling and chemiluminescent detection experience
- Familiarity with IVD product development under design control, ISO 13485, and/or GMP
- Experience with assay automation and tech transfer to manufacturing
Pay: From $90,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible schedule
Work Location: In person
