The individual in this position will work within the Assay Development department to develop protein- and exosome-based assays on our proprietary detection technology platform, Verita™, AC Electrokinetics/Lab on a Chip (ACE/LOC). The candidate must be familiar with new product development phases—establishing technical feasibility of an assay, development, transfer, verification, and validation. The candidate must be able to efficiently design and execute experiments, perform data analysis, and communicate results and observations effectively both as presentations and QMS-compliant documentation. This is a hands-on role, requiring an individual capable of designing and developing new assays utilizing our proprietary detection technology. The ideal candidate must be goal-oriented and must thrive in an entrepreneurial environment which necessitates a hands-on approach at all levels.
Essential Job Duties
- Is comfortable and effective at working with un-optimized platforms and driving them to repeatably meet performance specifications by developing proper calibrators and controls
- Determines approaches for endeavors that align with the company’s product development goals, with an emphasis on protein biomarker detection and development of robust assays
- Independently designs and performs experiments for R&D activities while providing insight and recommendations for achieving short and long-term goals
- Discovers and effectively communicates insights into the fundamentals of the interaction between the ACE/LOC technology and the biological variables that allow for a detection and quantification of biomarkers.
- Serves as mentor and project lead for other scientists, engineers and research associates in areas of expertise as needed
- Partners effectively with other members of the R&D team, as well as Engineering, Quality, Marketing, and all other departments in support of Product Development objectives
- Effectively communicates experimental findings in written and verbal formats during internal and external meetings
- Develops new analysis approaches for experimental data and discovers connections between unrelated variables
- Other responsibilities/projects as assigned.
- Ph.D. in Biochemistry, Bioengineering, Molecular Biology or a closely related field and 5+ years applicable industry work experience
- Expertise in biochemical assay design, construction and rollout to manufacturing; molecular assay and/or immunoassay experience in the same
- Experience in oncology, with a focus on protein analysis
- Expertise in formulation of biocompatible buffers
- Expertise with statistical data analysis and knowledge of statistical software such as GraphPad Prism or JMP is a plus
- Detail- and goal-oriented, with the ability to exercise independent judgment to determine methods and procedures on new assignments
- Skilled at writing QMS-compliant plans, reports, and SOPs
- Effective at planning, organizing, and prioritizing
- Strong troubleshooting and problem-solving skills
- Able to handle pressure and ambiguity and maintain composure and focus in situations of uncertainty
- Demonstrated sense of urgency to deliver high quality results under tight timelines
- Adept at building strong relationships and collaborating with colleagues at all levels
- Effective communication skills, both verbal and written