FSP - Sr. Scientist - Stability

Thermo Fisher Scientific • New Brunswick, NJ

222d

About The Position

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. 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. Global Biologics Stability (GBS) manages the stability programs for all commercial biologic Drug Substance and Drug Products across internal and external manufacturing sites. The principal scientist reports to the Associate Director of GBS and is responsible for stability product strategy and oversight of product stability programs. Activities include those associated with product stability strategy, impact assessments for investigations, change controls and temperature excursions, stability program requirements, approval of stability protocols, and preparation, review and approval of CMC elements of regulatory filings to support the activities of the Global Biologics Stability program for the company and Third Party Manufacturers (TPM).