Assay Development Consultant

  • location: Danvers, MA
  • type: Contract
  • salary: $40 - $45 per hour
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job description

Assay Development Consultant

job summary:
**URGENT NEED FOR A Research Associates level person who is responsible for the undertaking of research and development activities to support contracted pharma projects to develop companion diagnostics IVDs. This person will handle some lab responsibility as well as write SOPs**

 
location: Danvers, Massachusetts
job type: Contract
salary: $40 - 45 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Generating SOPs, work instructions, study protocols, and other project documentation, as needed.
  • Executing feasibility, development and verification runs for Immunohistochemistry (IHC) and In Situ Hybridization (ISH) In Vitro Diagnostic assays
  • Under the mentorship of the Technical Lead, perform routine laboratory operations tasks with supervision
  • Reagent preparation and automated biomarker staining on sectioned FFPE tissue samples
  • Data entry
  • Edit Quality documents and maintain Quality records of development
  • Work closely with Technical Lead to ensure deliverables are achieved in a timely manner through appropriate scheduling of work and communication on status of assigned tasks.
 
qualifications:
  • BS in related field
  • Ideal candidate has 1 to 4 Years industry experience preferably gained within an IVD development environment. Experience with IHC and ISH assay development is preferred
  • Outstanding writing skills with advanced proficiency in the MS suite of products
  • Ability to work in a regulated environment in which diagnostic assays are developed, commercialized and supported (i.e. FDA QSR, ISO 13485, etc.)
  • Good interpersonal skills with an ability to evaluate and concisely articulate scientific issues and contribute to the implementation of solutions.
  • Ability to perform in a dynamic, highly collaborative environment is critical
  • An ability to exercise sound scientific judgement within defined practices and techniques.
  • An ability to prioritize multiple tasks and manage priorities accordingly
  • Demonstrates a sense of urgency for project goals
  • Ability to work in a diverse team and be respectful of that diversity
 
skills: SOP, GLP (Good Laboratory Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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