Job ID: #9350
Principal Associate Scientist, Analytical Chemistry
Research & Development
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)
Commonwealth Sciences is a professional recruiting firm specializing in Life Science, Medical Device, and Engineering Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.