Analytical Development Scientist needed for the development and validation of analytical methods for starting materials, intermediates, new drug substances, new drug products and related compounds, in support of Product Development projects. Position is also responsible for troubleshooting of methods and assisting in method transfer to Quality Control. First main project will be the validation of the stability-indicating method for drug in development.. Other duties include researching and implementing new methods and technologies to enhance operations. Position will contribute to the preparation of chemistry, manufacturing and control (CMC) sections of regulatory submissions.
Position requires MS or BS in Chemistry or related discipline and a minimum of 5 or 10 years respectively of pharmaceutical experience in a development setting (or Ph.D. with 0-2 years) with an emphasis on development and validation of analytical methods. Qualified applicants will have substantial knowledge of HPLC, GC, LC/MS, spectroscopic, and/or wet chemical techniques is desirable; experience characterizing impurities in drug substances; working knowledge of regulatory guidances for analytical method validation, stability, CTD, and submission of analytical data. Must have high attention to detail, excellent communication skills (both oral and written), good organizational skills and multitasking abilities, strong troubleshooting skills, and the ability to work independently.
Apply for this position