job summary: **IMMEDIATE DIRECT HIRE NEED
for an ICH/ISH Assay Development Scientist. The Scientist will be responsible for making observations, preparing documents, reporting data and providing results to support key decisions within the organization.B
location: Danvers, Massachusetts
job type: Permanent
salary: $75,000 - 80,000 per year
work hours: 9 to 5
- Perform routine laboratory operations tasks with minimal supervision including but not limited to instrument maintenance, sample receipt and tracking, and inventory management.
- Work closely with a Senior Scientist to develop and execute feasibility, development and verification studies to support the development of Companion Diagnostic Immunohistochemistry (IHC) and In Situ Hybridization (ISH) assays.
- Work closely with a Senior Scientist to ensure deliverables are achieved in according to the project plan through appropriate scheduling of work and communication on status of assigned tasks.
- Prepare study protocols, reports, and presentations. Contribute to preparation of design control documents. Ensure all work is conducted in accordance with and compliant to applicable protocols, work instructions and standard operating procedures.
- BSc in a Scientific discipline required
- At least 4 years of successful IVD development experience in biotech/pharma environment.
- Experience with IHC and/or ISH assay development.
- Awareness of requirements and experience of working competently within a regulated environment in which diagnostic assays are developed, commercialized and supported such as: FDA QSR, or ISO 13485
skills: Analytical Chemistry, Chemistry, Medicinal Chemistry, ICH Regulations
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.