Responsibilities of the Principal Associate Scientist, Analytical Chemistry:

• Develop, validate and transfer non-complex to complex analytical methods.
• Research, prepare and review technical documents, including but not limited to SOPs, drug master files, technical packages, vendor qualification, raw material and release and stability specifications, stability summaries, test methods, and certificates of analysis which conform to company standards.
• Successfully investigate and resolve analytical problems, project issues and deviations.
• Accurately maintain all related documentation in compliance with SOPs.
• Prepare documents for regulatory filings (ANDA, NDA, ANDS). Design experiments and provide data to support responses for FDA minor deficiency letters.

Requirements of the Principal Associate Scientist, Analytical Chemistry:

• BS or MS with 5+ years experience supporting bioanalysis for non-clinical studies.
• Prior experience in analytical development of nucleic acids, nanoparticles, vaccines or related biopharmaceuticals
• Working experience with standard analytical methodologies, such as HPLC, LC-MS, and colorimetric/fluorometric assays.
• Solid experience on various additional characterization methods such as viscosity/rheology, texture analyzer, thermal analysis (DSC and TGA)