Senior Scientist Bio-/Chemical Quality Control

Job description

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. Position 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. Responsibilities: Processes and Analytical Methods ImplementationThe 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 LeadershipThe 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 and resource plans. Coordinating allocated resources in collaboration with QC management and other QC functions to ensure that timelines and project objectives are achieved. Driving collaboration within project teams and ensuring alignment with company strategy, priorities, and core values. Facilitating effective and timely communication within project teams and across relevant stakeholders. Leading and supporting structured problem-solving activities when issues arise in connection with assigned projects or tasks. Monitoring project progress, risks, milestones, deliverables, and KPIs and escalating potential delays or issues when appropriate. Promoting accountability by communicating expectations, ensuring transparency of relevant information, and proactively addressing or escalating conflicts and challenges. Supporting continuous improvement initiatives aimed at strengthening QC compliance, efficiency, quality, and overall performance. Establishing and maintaining effective relationships with external partners, including suppliers, contract laboratories, service providers, and universities. QC Execution and ComplianceThe Senior Scientist supports the compliant and timely execution of routine and non-routine QC activities and ensures appropriate documentation of analytical work. Responsibilities include: Ensuring that raw data, analytical results, reports, logbooks, and other relevant records are accurately documented, reviewed, and retained in accordance with applicable procedures and data integrity requirements. Supporting the investigation and resolution of analytical and quality-related issues, including requests associated with biochemical and chemical testing. Ensuring that deviations and laboratory investigations are initiated, investigated, documented, and completed in a timely and compliant manner. Providing scientific and technical expertise to support investigations, root cause analysis, and the definition of appropriate corrective and preventive actions, where applicable. Supporting responses to internal stakeholders, customers, sponsors, auditors, and Health Authority requests related to the assigned area of responsibility. Keeping the Head of BCQC appropriately informed regarding ongoing activities, project status, risks, and significant issues. Ensuring effective and transparent communication of relevant information to sponsors, stakeholders, project teams, and QC colleagues. Team Support and DevelopmentThe Senior Scientist contributes to the development of a strong, collaborative, and compliant QC organization by: Providing scientific and technical guidance to QC colleagues. Mentoring and supporting team members in GMP, Quality Control principles, analytical methods, and laboratory best practices. Supporting the planning and coordination of team activities and resources according to operational and project priorities. Contributing to recruitment activities and the onboarding and development of new team members. Promoting a culture of quality, accountability, collaboration, continuous improvement, and GMP compliance. Requirements: Degree (Master or higher) in biochemical / chemical/ pharmaceutical/ molecular sciences or similar Lower educational background could be accepted, as applicable, in case of former experience in the pharmaceutical industry Preferred Fields of Study: Chemistry, Biochemistry, Biology, Molecular Biology or related scientific field Min 2 years experience in GMP regulated industry 3-5 years lab experience Additional certifications in Quality Control/GMP practices beneficial Strong knowledge of GMP regulations and quality systems requirements Proficiency in analytical techniques including HPLC, GC, MS, spectrophotometry Experience with biochemical testing methods Strong documentation skills and proficiency with laboratory information management systems Knowledge of relevant regulatory standards (ISO, FDA, USP, EP) Excellent attention to detail and ability to follow written/verbal procedures