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