Scientist III - Process Development & Characterization Support

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking to fill a Scientist III - Process Development and Characterization Support position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in West Point, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship. Description: Support of standard analytical testing of samples from vaccines and large molecule process development/characterization. Other potential opportunities include method development/optimization. Qualifications - B.S./M.S. in Chemistry, Biology or similar life sciences Scientist 3 - B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience Required Skills and Experience Must have separations experience for large molecules Experience in analyzing vaccines and other large molecules using at least one of the following techniques: Liquid Chromatography (HPLC / UPLC) Other techniques such as: Protein A Titer, Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX, AEX, CEX), Reverse Phase (RP), or Hydrophobic interaction chromatography (HIC) Experience using spectroscopic techniques for investigating biopharmaceuticals (UV280, Raman, FTIR, fluorescence, light scattering Desired Skills and Experience General knowledge of process or analytical Ability to follow and execute against scientific protocols / procedures Preparation of analytical reagents (dilutions / solutions / buffers / mobile phases) Good documentation practices & utilization of electronic lab notebooks (Signals) Familiarity working in GxP environments, including standard method validation workflows Analytical software including Empower and/or Chemstation Ability to handle data from multiple analytical platforms Familiarity with Microsoft Office Applications (Outlook, Excel, Word, PowerPoint, OneNote, Teams, etc.) Responsibilities Laboratory stewardship including reagent and instrumentation maintenance Preparation and analysis of process samples Results processing and documentation by following appropriate methods / protocols / procedures Sample management and monitoring of controlled temperature units Analytical method validation support and method transfer Following all appropriate laboratory safety and hygiene procedures About Parexel FSP The CMC Operations group is part of Parexel FSP. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us! #LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.