Job Details
Position: Staff Scientist, IVD Assay Development
Company Overview
Join an industry-leading diagnostics company that is revolutionizing healthcare through innovative diagnostic solutions. This organization excels in developing advanced immunoassay technologies to address critical health conditions such as infectious and neurodegenerative diseases.
Job Summary
We are seeking a highly skilled Staff Scientist to spearhead and serve as the technical lead for the development of sophisticated immunoassays that can be implemented onto automated systems. This role involves driving technical projects, managing cross-functional teams, and ensuring the successful commercialization of diagnostic assays.
Key Responsibilities
- Lead the design, development, and optimization of complex immunoassays, including sandwich ELISA, competitive ELISA, and chemiluminescent immunoassays.
- Provide technical oversight and mentorship to a team of scientists, guiding experimental design and troubleshooting complex assay development issues.
- Employ advanced analytical techniques such as surface plasmon resonance (SPR), bio-layer interferometry (BLI), and flow cytometry to characterize antibody-antigen interactions and validate assay performance.
- Collaborate with engineering teams to integrate immunoassays into automated platforms, ensuring high throughput and reproducibility.
- Utilize statistical software (e.g., R, Python, JMP) to analyze experimental data, perform robustness testing, and ensure data integrity and reproducibility.
- Prepare and review documentation for regulatory submissions, ensuring compliance with ISO 13485 and FDA guidelines.
- Drive innovation by identifying and implementing new technologies and methodologies to improve assay sensitivity, specificity, and robustness.
- Work closely with cross-functional teams including molecular biology, bioinformatics, and quality assurance to ensure seamless integration of new assays into the product pipeline.
Qualifications
- B.S., M.S., or Ph.D. in Biochemistry, Molecular Biology, Immunology, or a related field.
- 5 years of experience in immunoassay development, ideally with experience in automated systems
- In-depth knowledge of immunoassay technologies, including ELISA, chemiluminescence, and multiplex assays. Experience with SPR, BLI, and flow cytometry is highly desirable.
- Proven track record of leading projects from concept to commercialization, with strong project management skills.
- Excellent written and verbal communication skills, with the ability to prepare detailed technical reports and presentations.