A growing CRO based in the Cleveland, Ohio area is seeking an LC-MS/MS Scientist to join its team. Should have at least two years of industry experience, preferably working in an API CRO/CMO environment.
- Work on impurity isolation using semi-prep chromatography, impurity identification, structural characterization, food migration, and extractable & leachable studies
- Perform routine HPLC-MS/MS and NMR analysis
- Work in an HPLC-MS/MS laboratory performing method development and validation of LC-MS/MS and NMR methods.
- Coordinate the timely and compliant generation of data to support client projects
- Review data for technical content and regulatory compliance
- Interact with clients to design scientifically sound studies
- Participate in ongoing equipment maintenance and qualification
- Maintain current expertise with all appropriate ICH, GMP, and FDA guidelines
B.S. or M.S. with 5 years of experience, or Ph.D. with 2 years of experience in chemistry or related field or equivalent combination of education and experience is required. Relevant experience with good manufacturing practices (GMP) and quality assurance is preferred.
Specific Skills and Requirements
- Experience with HPLC-MS/MS, NMR, semi-prep chromatography, lyophilization, etc.
- Experience with food migration and/or extractable and leachable studies
- Experience with lab procedures (extraction, solid phase extraction, dilution, etc.)
- Experience with, GC-MS, FTIR, desirable, but not required
- Be proficient in Microsoft Excel, Word, and PowerPoint
- Must have basic knowledge chemicals their properties, structure, reactivity, and be able to handle them with safe and appropriate techniques.
- Must be able to communicate effectively with coworkers and have good writing skills
- Must be able to effectively multi task