QC Material Specialist

We are seeking a Material Sciences Specialist for a 6-month assignment to support the end-to-end implementation and lifecycle management of critical materials in a GMP Quality Control environment. This role is key to ensuring consistency, regulatory compliance, and assay performance across in-process control, release testing, and product characterization.

As a subject matter expert, you will work independently while maintaining close alignment with the global Quality Control Sciences team. Your contributions will directly support the readiness of materials needed to ensure timely and compliant product release.

Company Description:
You’ll be joining a biotechnology organization focused on developing breakthrough therapies in oncology and immunology. With operations in both Europe and the U.S., the company leverages science, innovation, and a decentralized manufacturing model to deliver advanced cell and biologic therapies. The organization offers a collaborative, science-driven environment where consultants are treated as integral team members and empowered to drive meaningful outcomes.

Essential Requirements:

• 5+ years of experience in the pharmaceutical or biotechnology industry, preferably in a GMP-regulated Quality Control setting

• Proven expertise in the implementation and lifecycle management of critical raw materials, reagents, reference standards, and assay controls

• Strong knowledge of regulatory expectations for material qualification

• Experience conducting material risk assessments, managing change controls, and defining incoming goods specifications

• Excellent technical writing skills for GMP-compliant documentation

• Able to work independently with a proactive, solution-oriented mindset

• Strong communication and cross-functional collaboration skills

Desirable Requirements:

• Background in biologics, cell therapy, or advanced therapeutic platforms
• Hands-on experience with mammalian cell culture

• Prior experience developing SOPs and Work Instructions in line with GMP

• Familiarity with bridging strategies for reference standards and assay controls

• Experience aligning QC material readiness with cross-functional production and program timelines

Additional Insights:

• Location: Leiden, the Netherlands (2–3 days/week on site)

• Start Date: ASAP

• Duration: 6-month assignment

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