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44077 Ohio Full Time Posted: Thursday, 19 September 2019
Applicants who require a work visa considered

Essential Responsibilities

  • Work in a cGMP API stability laboratory.
  • Coordinate the timely and compliant generation of data to support client projects.
  • Perform OOS investigations, root cause analysis, author stability protocols and reports.
  • Review of stability protocols and reports
  • Review data for technical content and regulatory compliance.
  • Manage laboratory inventory, environmental chamber and information systems.
  • Interact with clients to design appropriate API and drug product batch release and stability studies.
  • Develop and maintain expertise with all appropriate ICH, FDA and EMEA guidelines.

Requirements Educational Qualifications

Minimal requirement a B.S. in chemistry (or related discipline) with 3+ years related analytical laboratory experience or equivalent combination of education and experience is required. Relevant experience in good manufacturing practices (cGMP) and laboratory quality control or stability is required.

Specific Skills and Requirements

Experience in standard lab instruments (HPLC, analytical balances, pH meter, etc.)

Familiarity with ICH stability guidelines is preferred

Experience with lab procedures (assay and impurities, dilution, etc.)

Be proficient in Microsoft Excel and Word

Experience with TotalChrom and ChemStation a plus

Experience with out of specification investigations, root cause analysis, would be preferred but not required

Must have basic knowledge of arithmetic, algebra, and statistics

Must be able to communicate effectively with clients and personnel

Must be able to effectively multitask

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.

44077 Ohio, United States of America
Bernadette Armbruster
9/19/2019 8:05:35 AM

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