Method Development Scientist
Essential Responsibilities
- Develop and validate HPLC methods for analyzing small-molecule drug substances and drug products.
- Conduct forced degradation studies and establish stability-indicating assays and impurity methods.
- Operate within a GLP/GMP-compliant laboratory, ensuring timely and accurate data generation for client projects.
- Perform routine analyses using HPLC, GC, NMR, MS, IR, ICP, KF, and other laboratory techniques.
- Draft and review scientific protocols and reports, ensuring accuracy and technical soundness.
- Stay updated on relevant ICH, GMP, and FDA guidelines to maintain compliance.
Educational Qualifications
- Bachelor’s, Master’s, or Ph.D. in Chemistry or a related field.
- A minimum of 5 years of analytical laboratory experience or an equivalent combination of education and experience.
- Previous experience in a GMP-regulated laboratory is required.
Specific Skills and Requirements
- Proficiency in standard laboratory instrumentation (e.g., HPLC, UPLC); experience with LCMS and GC is preferred but not mandatory.
- Competency with Microsoft Excel and Word.
- Fundamental understanding of chemical properties, structures, and reactivity, with the ability to handle chemicals safely and appropriately.
- Basic knowledge of arithmetic, algebra, and statistics.
- Strong communication skills for effective interaction with both laboratory and office personnel.
- Proven ability to manage multiple tasks efficiently.
