Scientist - Assay Development
A vibrant biotech company invested in making products that make a difference in health care, is in search of passionate Product Development Scientist, who can thrive in a fast-paced innovative environment. The individuals must be highly independent and hands on in the laboratory. Responsibilities:
- Experience with: assay, reagent development and formulation best practices in biological and diagnostic workflows
- Lateral Flow Assays or Personal diagnostic workflows development
- Familiarity with the process of obtaining FDA clearance/approval of In Vitro Diagnostic (IVD) products, preferably in molecular diagnostics
- Conduct and analyze evaluations for multi-step, multi-component biological workflows.
- Prepare and deliver analyzed reports to the team lead.
- Conduct and analyze routine baseline operations for multi-step, multi-component biological workflows.
- Prepare and deliver relevant analyses (timeline, component performance, etc.), suggesting root cause activities and corrective actions to team lead.
- Participate in development of appropriate test regimes and analyses to evaluate procedural modifications and improvements.
- Familiarity with statistical analyses using software such as SAS, JMP, R or Minitab beneficial
- Minimum of 3 years of industry experience with a Bachelor's degree in Engineering, Biology, Biochemistry, Molecular Biology, or Biological Engineering. Minimum of 1 year with a M.S. Alternatively, 4 years of directly related experience in lieu of degree may be considered as well.
- Working experience with all aspects of biological assay development on path to commercialization.
- Excellent organization, writing and communication skills are required, and the ability to interact well in group meetings/working environments.
- Laser-like attention to detail, ability to follow complex protocols accurately and reproducibly.
- Self-starter with a ferocious work ethic who can work independently, but who also functions well in a collaborative team environment.
- Familiarity with statistical testing processes, including trend analysis, accelerated aging techniques, and study design.
- Keen powers of observation, able to identify and capture critical insights associated with testing processes.
- Takes ownership of tasks and problems and provides solutions.
- Demonstrated soft skills: able to maintain excellent rapport with colleagues in the face of tight timelines and potentially contentious results.
Please send all resumes to for consideration.
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