The Assay Development Scientist will join a fast-growing team of chemists, biochemists, and bioengineers at Zymeron to develop in vitro diagnostic (IVD) assay technologies and products. The candidate will serve as a technical project manager/product development lead with main responsibilities including project planning, experiment design and execution, reports writing, collaborator communication and coordination, and scientific presentations. The candidate will work with assay developers to advance rapid diagnostic technologies toward product development and regulatory approval.
Duties and Responsibilities
1) Track 1 (material): Conduct rapid immunoassay development, including reagent screening, feasibility study, assay optimization and validation; Evaluate assay formats to enhance product commercial values.
2) Track 2 (device): integrate off the shelf and specially designed and 3D printed devices, develop novel device configurations to enhance product commercial values and marketability.
3) Coordinate technical transfer of new assays and procedures for validation and scaling up to clinical study sites and/or collaborator facilities
4) Design and lead studies to test hypotheses related to target product profiles. Analyze data, evaluate results, form conclusions, and determine future experiments
5) Present findings or project status reviews at internal or external meetings. Applies advanced technical writing skills to produce reports, proposals, and tech briefs
Required Key Competencies
1) Ph.D. or M.S. in Analytical Chemistry, Biomedical Engineering, Biochemistry, or related fields with 5+ years of relevant laboratory research or product development experience.
2) Strong background with minimum 5 years of experience in diagnostic tests, immunoassays, or paper-based assay technologies. Hands on experience in assay optimization, experimental design and versatile laboratory practice is a must.
3) Familiarity with in vitro diagnostic regulations such as CE-IVD, CLIA, LTD, and FDA US-IVD is preferred.
4) Proficiency in diagnostic assay, medical device product development is a plus.
5) Demonstrated attention to details.
6) Strong self-direction and well-developed interpersonal skills.