Scientist - Assay Validation - Product Commercialization - MA

Arlington Permanent USD100,000 - USD120,000 per year
  • Report Directly into the VP of Research & Development
  • Join a Company Pioneering Approaches to Quantitative DNA/RNA Detection

About Our Client

This Client's mission is to transform patient lives by delivering breakthrough innovations in infectious disease diagnostics. The Company is currently developing testing solutions based on the integration of novel technologies, including qPCR and microarray technologies, that enable rapid, quantitative, and highly multiplexed detection of microbial pathogens, resistance genes and host immune-response markers that ultimately lead to improved patient outcomes

Job Description

  • Extensive knowledge preparing and maintaining standard operating procedures (SOPs), with familiarity and adherence to GLP
  • Additional responsibilities will include support of documentation for compliance with FDA
  • Process patient samples using established lysis, purification, and assay SOPs as well as author new SOPs, validation protocols and reports
  • Design and implement validation and verification experiments to determine limit-of-detection and dynamic ranges for target pathogens and biomarkers on product panels.
  • Manage validation lab activities, includes reporting to the VP of Research and Development, managing clinical sample biobank, and critical reagent inventory
  • Prepare and maintain internal regulatory documents and SOPs as main point of contact for the QA team
  • 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

  • S. with 5+ years or an M.S. with 3-10 years of clinical laboratory experience.
  • 3+ years' experience or managing/leading in product development with a specific focus on in vitro diagnostic (IVD) products.
  • Experience with current molecular biology techniques with a focus on QPCR and nucleic acid extraction and purification
  • Excellent organizational, record keeping and communication skills
  • Demonstrated proficiency with data analyses and attention to detail

What's on Offer

  • Highly visible role, reporting to the VP of Research and Development
  • Work with highly disruptive technologies deliverying breakthrough innovations that change lives
  • Fun atmosphere, scientific career paths, opportunities to wear many hats
  • Competitive Compensation Package
  • Comprehensive Benefits Plan
  • Lots of opportunity for growth!
Faith Emery
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Job summary

Life Sciences
Sub Sector
Healthcare / Pharmaceutical
Contract Type
Consultant name
Faith Emery
Job Reference