Scientist, Assay Validation - Diagnostics - Somerville

Somerville Permanent USD100,000 - USD120,000 per year
  • Execute preparation efforts for regulatory filing and product commercialization
  • Contribute to the development of diagnostics that enable comprehensive treatment

About Our Client

My client's goal is to transform patient lives by progressing innovation in infectious disease diagnostics. They are currently developing testing solutions using their novel technologies, including qPCR and microarray technologies. These platforms enable rapid, quantitative, and accurate detection of microbial pathogens that lead to improved patient outcomes.

Job Description

  • Manage validation lab activities, clinical sample biobank, and critical reagent inventory
  • Experience with diagnostics in lab based position
  • Report to the VP of Research and Development
  • Extensive knowledge preparing and maintaining standard operating procedures (SOPs) in a GLP environment
  • Process patient samples using lysis, purification, and assay SOPs
  • Author new SOPs, validation protocols and reports
  • Prepare and maintain internal regulatory documents as main point of contact for the Quality Assurance team
  • Design and implement validation/verification experiments to discover limit-of-detection and dynamic ranges for target pathogens and biomarkers
  • Support of documentation for compliance with FDA
  • Collaborate with principal investigators on clinical trial design for FDA submission and compliance

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • B.S. with 5+ years of clinical laboratory experience, preferably within diagnostics
  • M.S. with 3-10 years of clinical laboratory experience, preferably within diagnostics
  • 3+ years experience executing product development, specifically in vitro diagnostic (IVD) products
  • Experience with molecular biology techniques, specifically with QPCR and nucleic acid extraction/purification
  • Excellent organizational, documentation, and communication skills
  • Demonstrated success with data analyses and attention to detail

What's on Offer

  • Highly competitive base salary
  • Great PTO and health benefits
  • Annual bonus
  • Stock options
  • Cross functional, fast paced environment
  • Amble opportunity for upward mobility
  • Ability to manage a small team
Connor Colombo
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Job summary

Life Sciences
Sub Sector
Healthcare / Pharmaceutical
Contract Type
Consultant name
Connor Colombo
Job Reference