Senior Scientist, Material Qualification & Release (QC GMP)

<p style="text-align:left"><b>Work Schedule</b></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p><p>Are you ready to make a meaningful impact in the world of science? Join Thermo Fisher Scientific as a <b>Senior Scientist, Material Qualification &amp; Release (QC GMP)</b> within our Quality Control organization at our Lengnau site.</p><p>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.</p><div></div><p><b>Discover Impactful Work</b></p><p>As a Senior Scientist within Services &amp; 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.</p><p>This position requires strong technical expertise, regulatory knowledge, and the ability to lead complex quality topics across internal and external laboratories.</p><div></div><p><b>Key Responsibilities</b></p><p><b>Material Qualification &amp; Release</b></p><ul><li>Lead and execute the GMP-compliant release of raw materials used in manufacturing.</li><li>Drive the QC-related aspects of material qualification to ensure full alignment with health authority and regulatory requirements.</li><li>Serve as SME for raw material analytics, providing expert support during deviations, OOS/OOT investigations, troubleshooting, and continuous improvement initiatives.</li><li>Collaborate with internal and external laboratories to ensure robust analytical execution and data integrity.</li></ul><p></p><p><b>Compliance &amp; Regulatory Readiness</b></p><ul><li>Act as investigator for deviations and assigned change controls, ensuring timely and compliant resolution.</li><li>Author, review, and maintain GMP-relevant documentation (SOPs, risk assessments, reports, protocols).</li><li>Conduct gap assessments and define/implement remediation measures to maintain inspection readiness.</li><li>Support and actively participate in health authority and customer inspections and audits.</li></ul><div></div><p><b>Who We Are Looking For</b></p><p><b>Education</b></p><ul><li>Bachelor’s or Master’s degree in Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, or a related scientific discipline.</li><li>Equivalent professional experience in a GMP-regulated pharmaceutical or biopharmaceutical environment will be considered.</li></ul><p></p><p><b>Experience</b></p><ul><li>Minimum 5 years of experience in a GMP laboratory within the pharmaceutical or biopharmaceutical industry.</li><li>Demonstrated expertise in raw material qualification and release within a GMP-regulated manufacturing environment.</li><li>Strong working knowledge of health authority expectations and regulatory compliance.</li><li>Proficiency in technical English (written and spoken).</li></ul><p></p><p><b>Skills &amp; Competencies</b></p><ul><li>Strong commitment to quality, compliance, and data integrity.</li><li>Structured, risk-based mindset with high attention to detail.</li><li>Ability to work independently while effectively collaborating cross-functionally.</li><li>Strong analytical thinking and problem-solving capabilities.</li><li>Excellent communication, organizational, and prioritization skills.</li><li>Interest in digitalization and modernization of analytical systems and QC processes.</li><li>Continuous learning mindset with motivation to further develop technical and regulatory expertise.</li></ul><p></p><p></p><p></p><p></p>