Senior Scientist, Chromatography

Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Join us as Senior Scientist! 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. Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. As a Senior Scientist, your role will be to conduct advanced diagnostic tests, ensure the highest accuracy and reliability of laboratory data, mentor junior scientists, and drive continuous improvements in laboratory methodologies and quality standards. What You’ll Do: Trains on routine operation, maintenance, and theory of complex  analytical instrumentation, SOPs, and regulatory procedures and  guidelines. • Independently performs and gives guidance on a variety of routine to  complex sample preparation and analysis procedures to  quantitatively measure pharmaceutical and biopharmaceutical  compounds in a variety of formulations and/or biological matrices for  stability and analytical testing. • Completes all laboratory documentation in clear and accurate  language and according to SOP and GLPs. • Independently troubleshoots equipment & instruments. Mentors’ others in troubleshooting when applicable. • Reviews and compiles results from assignments and makes initial  determination on acceptability per SOP acceptance criteria. Navigates  the OOS/OOT/Atypical investigation process. Leads investigations and  Root Cause Analysis and proposes CAPAs. • Performs work assignments accurately, and in a timely and safe  manner. • Independently manages QC responsibilities. Communicates project  status to project leader and helps to identify gaps and anticipates  roadblocks in project team workflow. • Coordinates laboratory activities of other team members in  conjunction with the lab supervisor. • Assists with the study design & protocol authoring. Leads data  evaluation and study close-out. • Independently completes QA facing tasks. Authors and leads more  complex quality records (eg. quality records which may require more  in-depth investigation to identify true root causes, quality records  requiring cross-departmental input and/or collation of data etc.) Education and Experience: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 5+ years). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Knowledge of routine operation, maintenance, and theory of analytical instrumentation,  SOPs, and applicable regulatory authority, compendia and ICH guidelines and ability to  interpret and consider SOP