Biocompatibility Materials Qualification Coordinator

Fresenius Kabi; Lake Zurich (IL); On-site; USD 75,000 - 80,000; Full time

Benefits offered by this job

Bonus plan (6% target)

401(k) with company contributions

Vacation and holidays plus personal/s.

Health benefits: medical, dental, and視

Job summary

Fresenius Kabi Lake Zurich, IL, seeks an Associate Project Manager to support medical device material qualification activities within the Transfusion and Cell Therapies division. You will coordinate outsourced biocompatibility studies, manage protocols and documentation, and support risk-based testing plans under ISO and FDA guidelines.

The role requires 3+ years in related fields, a chemistry/biology degree, and strong communication skills.

Qualifications

• Bachelor’s degree in chemistry, biology, or related discipline required.
• Minimum 3 years of experience in a related role.
• 1 year of project management experience preferred.
• Familiarity with ISO 10993-1 and related parts, USP standards.
• Advanced knowledge of Office software applications.
• Experience coordinating outsourced scientific service providers.
• Experience coordinating scientific studies.
• Strong attention to detail and excellent communication skills.

Responsibilities

• Coordinate Fresenius Kabi Lake Zurich Biocompatibility program for high-volume material qualification projects.
• Prepare, review and approve protocols and reports for materials qualification and biocompatibility testing.
• Identify risks, perform gap analyses and communicate mitigation strategies.
• Assist engineering with materials qualification documentation.
• Develop and maintain policies and standards for medical device material qualification processes.
• Coordinate CRO relationships and supplier quality audits; ensure GLP compliance and regulatory alignment.
• Review study protocols and CRO reporting; resolve non-conformances; ensure data accessibility.

Skills

Project management

Communication

Analytical skills

Attention to detail

Research skills

Life science knowledge

Education

Bachelor’s degree in chemistry/biology or related discipline

Tools

Microsoft Office (Outlook, Word, Excel, PowerPoint)

Job description

Fresenius Kabi Lake Zurich, IL, seeks an Associate Project Manager to support medical device material qualification activities within the Transfusion and Cell Therapies division. You will coordinate outsourced biocompatibility studies, manage protocols and documentation, and support risk-based testing plans under ISO and FDA guidelines.

The role requires 3+ years in related fields, a chemistry/biology degree, and strong communication skills.