Senior Scientist Bio-/Chemical Quality Control

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join our Quality Control team at Thermo Fisher Scientific where you'll make meaningful contributions to our mission of enabling customers to make the world healthier, cleaner and safer. As a Senior Scientist, you will support the establishment and operational readiness of the Bio-/Chemical Quality Control (BCQC) unit at the Thermo Fisher Scientific Lengnau site in accordance with project timelines. Key responsibilities include contributing to the transfer, verification, and validation of analytical methods, as well as the qualification of laboratory equipment required for testing activities. The role also actively supports GMP inspection readiness by ensuring compliance with applicable Quality Systems, procedures, and documentation requirements. In addition, it contributes to overall QC operational readiness through the management and coordination of internal and external projects, resource allocation, and the planning and prioritization of daily team activities. This role offers excellent opportunities for professional growth while working alongside colleagues who share your commitment to science and quality.

Summary: The Senior Scientist Bio-/Chemical Quality Control (BCQC) plays a key role in establishing, implementing, and maintaining compliant QC processes and analytical methods for the testing of finished products, in-process controls, intermediates, raw materials, utilities, and cleaning samples. The position combines scientific expertise, GMP compliance, and project leadership. The Senior Scientist is responsible for coordinating analytical activities, supporting the implementation and lifecycle management of methods and equipment, leading local and global QC projects, and ensuring that activities are completed in accordance with defined quality requirements and timelines. The role works closely with QC management, internal stakeholders, project teams, external partners, suppliers, contract laboratories, and other functions to ensure operational excellence and continuous improvement within BCQC.

Processes and Analytical Methods Implementation The Senior Scientist coordinates activities required to establish and maintain QC processes and analytical methods within the assigned area of expertise. Key responsibilities include: Authoring and revising Standard Operating Procedures (SOPs), Work Instructions (WIs), and other controlled documents in compliance with GMP requirements and established timelines. Acting as Subject Matter Expert (SME) for the review and approval of analytical methods, plans, protocols, reports, and other technical documentation. Coordinating the procurement, qualification, calibration, maintenance, and lifecycle management of analytical and laboratory infrastructure equipment. Supporting the procurement, preparation, manufacturing, qualification, and verification of test, reference, and control materials. Coordinating and executing the development, transfer, verification, qualification, and validation of analytical procedures according to applicable regulatory requirements and project timelines. Reviewing analytical raw data, equipment qualification and maintenance records, and other relevant BCQC documentation to ensure accuracy, completeness, data integrity, and GMP compliance. Ensuring that analytical processes and methods are appropriately implemented and maintained to support reliable and compliant routine QC operations. Project Leadership The Senior Scientist represents BCQC in cross-functional projects, working groups, and local and global initiatives and ensures that project requirements, resources, workload, timelines, and deliverables are clearly defined. Key responsibilities include: Leading the implementation of local and global projects within QC and ensuring effective planning and execution of assigned activities. Translating project requirements into clear, data-driven workload