Senior Scientist, Material Qualification & Release (QC GMP)

About the job

Work Schedule

Environmental Conditions

Job Description

Are you ready to make a meaningful impact in the world of science? Join Thermo Fisher Scientific as a Senior Scientist, Material Qualification & Release (QC GMP) within our Quality Control organization at our Lengnau site.

In this role, you will play a pivotal part in ensuring GMP compliance, material integrity, and operational excellence — directly contributing to our mission of enabling our customers to make the world healthier, cleaner, and safer.

Discover Impactful Work

As a Senior Scientist within Services & Support Quality Control, you will act as the subject matter expert (SME) for raw material qualification and release in a GMP-regulated manufacturing environment. You will ensure that materials and associated analytical processes meet regulatory requirements and remain in a continuous state of compliance.

This position requires strong technical expertise, regulatory knowledge, and the ability to lead complex quality topics across internal and external laboratories.

Key Responsibilities

Material Qualification & Release

• Lead and execute the GMP-compliant release of raw materials used in manufacturing.
• Drive the QC-related aspects of material qualification to ensure full alignment with health authority and regulatory requirements.
• Serve as SME for raw material analytics, providing expert support during deviations, OOS/OOT investigations, troubleshooting, and continuous improvement initiatives.
• Collaborate with internal and external laboratories to ensure robust analytical execution and data integrity.

Compliance & Regulatory Readiness

• Act as investigator for deviations and assigned change controls, ensuring timely and compliant resolution.
• Author, review, and maintain GMP-relevant documentation (SOPs, risk assessments, reports, protocols).
• Conduct gap assessments and define/implement remediation measures to maintain inspection readiness.
• Support and actively participate in health authority and customer inspections and audits.

Who We Are Looking For

Education

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, or a related scientific discipline.
• Equivalent professional experience in a GMP-regulated pharmaceutical or biopharmaceutical environment will be considered.

Experience

• Minimum 5 years of experience in a GMP laboratory within the pharmaceutical or biopharmaceutical industry.
• Demonstrated expertise in raw material qualification and release within a GMP-regulated manufacturing environment.
• Strong working knowledge of health authority expectations and regulatory compliance.
• Proficiency in technical English (written and spoken).

Skills & Competencies

• Strong commitment to quality, compliance, and data integrity.
• Structured, risk-based mindset with high attention to detail.
• Ability to work independently while effectively collaborating cross-functionally.
• Strong analytical thinking and problem-solving capabilities.
• Excellent communication, organizational, and prioritization skills.
• Interest in digitalization and modernization of analytical systems and QC processes.
• Continuous learning mindset with motivation to further develop technical and regulatory expertise.