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.
