Job Title
Material Qualification Scientist
Job Profile
S
ummary:
The Material Qualification Scientist provides guidance to R/D teams, Manufacturing, Quality and Regulatory Affairs personnel on testing requirements for plastics, Elastomeric components and medical devices used in pharmaceutical manufacturing processes, drug and medical device products. The Material Qualification Scientist works with project team members and coordinates biological and physicochemical testing performed by approved contract laboratories. Moreover, the Material Qualification Scientist authors scientific protocols and completes scientific reports qualifying the materials for human use.
Major Duties and Responsibilities:
Determine and coordinate USP, EP, JP and ISO 10993-1 tests on medical materials including extractions, and testing for turbidity, reducing agents, heavy metals, pH, total extractables, cytotoxicity, systemic toxicity, Intracutaneous reactivity, hemolysis, sensitization and Genotoxicity by use of contract laboratories.
Review contract lab protocols and reports and summarize data into a Scientific Report.
Author Material Qualification SOPs.
Approve commodity specification change requests for material related changes.
Maintain accurate test records and manage all documentation requirements in full conformance to cGMPs.
Skills/Experience Education/Certification
Requirements:
A Bachelors Degree in Analytical Chemistry, Microbiology, Engineering, or equivalent is required. A Masters degree is preferred. 1 - 3 years experience in a regulated environment and familiarity with GLP, GMP, ICH, USP, EP, JP and ISO requirements. Excellent communication and problem solving skills.
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Location: USA-IL |
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Posted on
Aug 18,2026 |
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Company info
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