MRB Associate Scientist Analytical Research & Development

Description Overview

The Perrigo Analytical Development (AD) department, specializing in solid and liquid Over-the-Counter (OTC) products, is looking to add a talented colleague to our AD team.  This position will require travel between the Allegan and Holland Michigan campuses. 

Applies technical expertise and complex methodologies to conduct and/or design experiments in support of product formulation and regulatory submission. Provides scientific and technical support to existing drug products in a cross-functional team setting, primarily MRB (material review board).Our primary focus is to provide technical support to assigned projects, using robust scientific methods which comply with standard operating procedures and scientific standards. Works with direction from senior scientific staff. 

Scope of the Role

• Support the qualification of raw material supplier changes and alternate sources for use in existing finished products by conducting/overseeing analytical assessments, method development, and method validation to ensure product compliance.
• Individually contribute the creation of product specifications and test methods which are robust and meet regulatory requirements. Prepare documents for regulatory filings (ANDA, NDA, ANDS).
• Perform physical and chemical testing on raw material, in-process, finished product and stability samples. This includes documentation and review.
• Research, prepare and review technical documents, including but not limited to SOP’s, drug master files, technical packages, vendor qualification, raw material and release and stability specifications, stability summaries, test methods, and certificates of analysis which conform to company standards.
• Attend and present data at project-related meetings, interact with other departments and outside testing laboratories to ensure proper analytical testing. Participate in cross-functional project teams, and exercise and build basic team effectiveness skills.
• Individually contribute to the development, validation and transfer activities associated with non-complex to complex analytical methods.

Experience Required

• The skills required for this role are normally acquired through completion of a:

Bachelor’s degree in Chemistry or Pharmaceutical Sciences OR a

Master's degree in Chemistry or Pharmaceutical Sciences

• Knowledge of a variety of analytical instruments for physical and chemical analyses including but not limited to analytical balances, pH meters, HPLC, UPLC, USP dissolution testing apparatus, and moisture analysis by Karl Fischer.
• Familiarity with a variety of compendial references including the United States and European Pharmacopeia.
• The ability to clearly document and precisely execute analyses and experiments of moderate complexity which includes maintenance of high quality documentation, analysis and proper interpretation of data, and preparation of reports, presentations, or other technical communications as necessary.
• Effective communication within direct Analytical team, on focused technical and non-technical teams, and with cross-functional groups.
• Ability to operate effectively in a team oriented culture focused on a sense of shared scientific inquiry, collaborative engagement, innovation, and the pursuit of scientific excellence.