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Method Development Associate Scientist/Scientist

2 months ago

Painesville, Ohio, United States Olon Ricerca Bioscience LLC Full time
Job Overview

Olon Ricerca Bioscience LLC is seeking a highly skilled Scientist - Analytical Method Development to join our team in the development and validation of analytical methods for small molecule drug substances and drug products.

Key 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, ensuring 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, ensuring technical content and accuracy.
  • Maintain current expertise with relevant ICH, GMP, and FDA guidelines.

Requirements:

A B.S. to Ph.D. in Chemistry or a related field, with 5+ years of analytical laboratory experience or an equivalent combination of education and experience, is required. Relevant experience in good manufacturing practices (GMP) laboratory is essential.

Desirable Skills and Qualifications:

  • Experience with standard lab instrumentation (HPLC, UPLC, etc.).
  • Experience with LCMS and GC is preferred but not required.
  • Proficiency in Microsoft Excel and Word.
  • Basic knowledge of chemicals, their properties, structure, reactivity, and the ability to handle them safely and appropriately.
  • Basic knowledge of arithmetic, algebra, and statistics.
  • Effective communication skills to interact with all plant and office personnel.
  • Ability to effectively multitask.