Senior Materials Scientist: Raw Materials Qualification

cGMP Consulting Inc.; Joliet (IL); On-site; USD 110,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

PTO

401K

Job summary

cGMP Consulting seeks a seasoned materials expert to lead raw material qualification for medical devices, ensuring compliance with cGMP and FDA guidelines. You will evaluate specifications, review CoAs, and collaborate with R&D, quality, procurement, and manufacturing teams.

The role requires 5–8 years in material characterization, strong analytical skills, and hands-on experience with polymers, elastomers, metals, or coatings to support supplier changes and investigations.

Qualifications

• 5–8 years of relevant experience in raw material characterization, analytical testing, material qualification, or specification development.
• Hands-on experience evaluating raw material testing specifications, acceptance criteria, and purchasing specifications.
• Familiarity with ISO 13485, ISO 14971, ISO 10993, and relevant ASTM/ISO/USP standards.

Responsibilities

• Evaluate and develop raw material testing specifications, including test parameters, analytical methods, sampling requirements, and acceptance criteria.
• Review and optimize raw material purchasing specifications to align with product requirements and internal standards.
• Analyze supplier CoAs, safety data sheets, and other technical documentation to assess material compliance.
• Characterize raw materials using analytical techniques (FTIR, DSC, TGA, GPC/SEC, rheology, etc.) as applicable.
• Establish acceptance limits based on material properties, historical data, and risk assessments.
• Collaborate with R&D, analytical sciences, quality, procurement, and manufacturing to resolve material-related challenges.

Skills

Raw material characterization

Analytical testing

Specification development

Supplier quality documentation

Risk assessment

Change control

Education

M.S. or M.Tech in Materials Science and Engineering

B.E./B.Tech with relevant experience

Tools

FTIR

DSC

TGA

GPC/SEC

Chromatography

Rheology

Job description

cGMP Consulting seeks a seasoned materials expert to lead raw material qualification for medical devices, ensuring compliance with cGMP and FDA guidelines. You will evaluate specifications, review CoAs, and collaborate with R&D, quality, procurement, and manufacturing teams.

The role requires 5–8 years in material characterization, strong analytical skills, and hands-on experience with polymers, elastomers, metals, or coatings to support supplier changes and investigations.