Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

• Responsible for the development and implementation of the bioanalytical strategy by working closely with cross-functional team members and acting as a key member of project/indication teams.
• As a bioanalytical expert, responsible for developing assay validation strategies that comply with regulatory guidelines and industry best practices.
• In collaboration with the sourcing manager and program manager, oversee the timely commissioning of validation packages and the bioanalysis of clinical trials by bioanalytical vendors. Participate in vendor governance meetings, as appropriate.
• As a bioanalytical study monitor, responsible for the oversight of bioanalytical study phases of clinical trials, including the review of sample analysis plans and reports, and for providing input into clinical trial documents (e.g., clinical study protocols, data transfer agreements, lab manuals, etc.).
• Participate in project team meetings as a recognized bioanalytical expert.
• Collaborate with medical writers in drafting the bioanalytical modules in regulatory documents.
• Contribute to interactions with regulatory agencies.
• Stay current with relevant literature, maintaining awareness of scientific and bioanalytical developments and how they may apply to argenx clinical development programs.
• Present results and findings at internal multidisciplinary project, clinical, and bioanalytical team meetings.

• PhD degree or equivalent experience.
• At least 5 years of industry experience in the field of bioanalytical sciences.
• Hands-on experience with ligand binding assay methods and platforms; experience with LC-MS technology for large molecules is a plus.
• Experience in analyzing human samples in support of clinical trials, with a solid understanding of GCP/GCLP guidelines and other current global regulations.
• Experience in the development and validation of PK, PD, and immunogenicity assays for large molecules, including knowledge of the respective regulatory guidelines.
• Experience running outsourced activities.