Scientist

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. Location/Division Specific Information 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 clients to make the world healthier, safer, and cleaner. Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use 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. Discover Impactful Work The DDS-AD-EC(US) is well equipped with modern instrumentation for structural characterization pharmaceuticals including various mass spectrometers, biophysical and analytical tools. This position will be in the DDS-AD-EC(US) Structural Analysis and Characterization (SA&C) group and will provide an opportunity to lead key activities required for progression of small and large molecule assets. A day in the Life Provide structural characterization of various API and protein therapeutics using vibrational spectroscopy. Characterize and identify foreign particulates by optical and digital microscopy, vibrational spectroscopy, and SEM-EDX. Characterize sub-visible and visible particulates by flow-imaging and LS techniques. Develop and implement various methods for structural characterization of coformulations and long-acting injectables (LAIs). Develop and implement various methods for sizing of various APIs in coformulations and LAIs. Develop and implement various methods for analysis and characterization of aggregate and particle formation in protein therapeutics. Provide high quality data and aid in drafting of sections for characterization reports and regulatory submissions. Represent line function in project teams and/or sub teams. Keys to Success Education and Experience A BS or MS degree in protein biochemistry, biophysics, pharmaceutical sciences or related fields 4-6 years of experience with an BS degree; 1-3 years with an MS degree 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.

API characterization using vibrational spectroscopy (VCD, IR and Raman). Experience in protein structure analysis such as secondary and tertiary structure, protein folding-unfolding, aggregates, and particles characterization and quantification using various spectroscopic and biophysical techniques including FTIR, CD, VCD, DSC, AUC, Fluorescence, SEC-MALS, particle analysis technologies (DLS, Micro-Flow Imaging, and HIAC). Elemental analysis using SEM-EDX. Proficient in and demonstrates highly effective oral and written communication skills. Team player and ability to work in a matrix environment. Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance Ability to