Senior Scientist, Material Qualification and Release (QC GMP)
As the world leader in serving science, our work is more than something that fills our days – what we do has great purpose. Our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint. Our broad customer base, from research to clinical to commercial production means you can have a broad and meaningful impact here at Thermo Fisher Scientific. All while working in an environment where you will be supported, valued and rewarded for your performance.
Senior Scientist, Material Qualification and Release (QC GMP)
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
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 for raw material qualification and release in a GMP-regulated manufacturing environment. You will ensure that materials 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.
