Method Development Associate Scientist/Scientist
Essential Responsibilities
- Develop and validate HPLC procedures for small molecule drug substances and drug products.
- Perform forced degradation studies and develop stability-indicating assay and impurities methods
- Work in a GLP/GMP laboratory. Coordinate the timely and compliant generation of data to support client projects.
- Perform routine HPLC, GC, NMR, MS, IR, ICP, KF and other analysis and validation studies.
- Author and review protocols and reports. Review data for technical content and accuracy.
- Maintain current expertise with relevant ICH, GMP, and FDA guidelines.
Requirements Educational Qualifications
B.S. to Ph.D. in Chemistry or related field with 5+ years analytical laboratory experience or equivalent combination of education and experience is required. Relevant experience in good manufacturing practices (GMP) laboratory is required.
Specific Skills and Requirements
- Experience with standard lab instrumentation (HPLC, UPLC, etc.)
- Experience with LCMS and GC preferred but not required.
- Be proficient Microsoft Excel and Word
- Must have basic knowledge chemicals their properties, structure, reactivity, and be able to handle with safe and appropriate techniques.
- Must have basic knowledge of arithmetic, algebra, and statistics.
- Must be able to communicate effectively with all plant and office personnel.
- Must be able to effectively multi task
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