Product Development - Assay Development

Company: Apex Systems
Location: New Haven
Posted on: November 24, 2020

Job Description:

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 clearanceapproval 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 Qualifications 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 meetingsworking 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 qualified candidates to EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or

Keywords: Apex Systems, New Haven , Product Development - Assay Development, Other , New Haven, Connecticut