HPLC Method Development Scientist
Posted on Aug 9, 2019 by OlonRicerca Bioscience
- Develop and validate stability-indicating 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 GMP laboratory. Coordinate the timely and compliant generation of data to support client projects.
- Perform routine HPLC analysis and validation studies
- Author protocols and reports. Review data for technical content and regulatory compliance.
- 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 in standard lab instrumentation (HPLC, UPLC, etc.)
- Experience with LCMS or GC preferred but not required
- Be proficient in LIMS, 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
Olon Ricerca Bioscience LLC. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.