Role SummaryThe Analytical Scientist will perform analytical testing of pharmaceutical products, drug-device combination products, and materials supporting current products, new product development, stability studies, and analytical services. Responsibilities include chromatographic analysis, method development and validation, and GMP-compliant documentation.ResponsibilitiesPerform wet chemistry and instrumental testing using HPLC, GC, dissolution, and texture analysis.Analyze raw materials and finished products according to approved methods and specifications.Use Empower or similar chromatography data systems.Document and archive results using electronic laboratory notebooks and LIMS in compliance with GMP.Support method development, validation, stability, and product understanding studies.Prepare technical documents, including methods, protocols, reports, work instructions, and specifications.Support laboratory equipment qualification, calibration, and maintenance.Apply critical thinking, problem-solving, and data analysis skills.Prioritize multiple projects and adapt to changing priorities.Maintain a strong commitment to laboratory safety and quality.Work effectively both independently and as part of a team.Basic QualificationsBachelors degree or higher in Chemistry or a related science discipline.Basic understanding of GMP.At least 1 year of analytical testing experience or equivalent laboratory coursework.Preferred QualificationsExperience with Empower or similar chromatography data acquisition systems.Experience with GMP-compliant laboratory documentation.Demonstrated technical writing and data analysis skills.
Not specified in the original listing.
Not specified in the original listing.
