Product Development - Assay Development

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Apex Systems
Development, FDA, Diagnostic, SAS, Engineering, Biology, Biochemistry, Systems, Scripts
Full Time

Job Description

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


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 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.

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


Company Information

Apex Systems is a world class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients’ digital visions. We provide a continuum of service from workforce mobilization and modern enterprise solutions to digital innovation to drive better results and bring more value to our clients. Apex transforms our customers with modern enterprise solutions tailored to the industries we serve. Apex has a presence in over 70 markets across US, Canada and Mexico. Apex is a segment of ASGN Inc. (NYSE: ASGN)

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Dice Id : apexsan
Position Id : BHJOB2374_1104867
Originally Posted : 1 month ago

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