CMC Scientist - 2055100

ASGN • Overland Park, KS

397d • $108,160 - $108,160

About The Position

The Chemist role at Apex Systems involves working on biocompatibility standards and requirements for medical devices. The position requires collaboration with various teams to develop testing strategies, assess compliance, and prepare documentation for regulatory submissions. The role emphasizes accuracy, attention to detail, and the ability to manage multiple projects effectively.

Requirements

• 3-5 years of experience in the medical device industry or biocompatibility research organization.
• Deep knowledge of ISO 10993 standards for biocompatibility.
• Experience with sample preparation and extraction techniques for material analyses.
• Familiarity with analytical chemistry and instrumentation analysis (e.g., FTIR, HPLC, GC).
• Ability to interpret laboratory data and scientific literature.
• Experience in a Design Control environment and knowledge of quality systems.
• Strong oral and written communication skills.

Nice To Haves

• Experience in polymers and analytical chemistry.
• Auditing skills and knowledge of regulatory submissions.
• Critical thinking skills to resolve technical challenges.

Responsibilities

• Develop biocompatibility testing strategies for medical devices.
• Review and assess gaps for legacy devices to ensure compliance.
• Collaborate with the Biocompatibility team on testing strategies.
• Coordinate testing through outside laboratories and monitor studies.
• Author Toxicological Risk Assessment Reports and Biocompatibility Risk Assessment Reports.
• Support interactions with regulatory bodies regarding biocompatibility data.
• Maintain biocompatibility documents for EU Medical Device Regulations (MDR).
• Prioritize assignments to meet project schedules and timelines.

Benefits

• Competitive hourly rate of $45-$52/hour.
• Potential for contract extension after 6 months.
• Access to career resources, training, and development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree