*Work Schedule* Standard (Mon-Fri)*Environmental Conditions* Adherence to all Good Manufacturing Practices (GMP) Safety Standards*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. Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner. Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. Reporting to the Associate Director, CMC QC Stability, will be responsible for managing routine operations of the cell banks, critical intermediates, Drug Substance and Drug Product for clinical GMP stability programs of cell and genetic therapies while ensuring compliance with SOPs, internal policies and industry guidance. In addition, this role will be responsible for supporting various GMP stability testing programs and Quality Systems, including handling stability Quality Events, performing stability testing, delivering stability documents and coordinating with external resources (CTOs, CMOs, etc.).
Bachelors degree or equivalent is required plus a minimum of 2 years of relevant experience; or Master's degree. CLEARANCE REQUIREMENTS: Department of Defense Secret security clearance is required within a reasonable period of time. Applicants selected will be subject ...
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