Scientist/Sr. Scientist AR&D
Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it.
Provides technical support to assigned projects, using robust scientific methods which comply with standard operating procedures and scientific standards. Works with limited direction. As appropriate, may serve as a project leader to manage analytical support for projects with minimal supervision.
- Perform physical and chemical testing on raw material, in-process, finished product and stability samples. This includes documentation and review.
- Develop, validate and transfer non-complex to complex analytical methods.
- Research, prepare and review technical documents, including but not limited to SOPs, 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.
- Successfully investigate and resolve analytical problems, project issues and deviations. Accurately maintain all related documentation in compliance with SOPs.
- Prepare documents for regulatory filings (ANDA, NDA, ANDS). Design experiments and provide data to support responses for FDA minor deficiency letters.
Bachelors of Science degree; Typically a minimum of 4 years work experience required.
Helpful Experience and Skills
- Hands on experience and troubleshooting skills on chromatographic separation (GC, GC-MS, HPLC, UPLC and LC-MS), particle size distribution (laser diffraction and mechanical sieving), light microscopy, spectrophotometric (FTIR, UV-VIS), dissolution techniques, moisture analysis by Karl Fischer.
- Solid experience on various additional characterization methods such as viscosity/rheology, texture analyzer, thermal analysis (DSC and TGA)
- Knowledge of the United States Pharmacopeia, European Pharmacopeia, applicable FDA Guidance & ICH Guidelines
- Proficiency on method development of assay, impurities, dissolution, water content, and physical characterization methods for different dosage forms
Depending on the qualifications of the selected candidate, the role may be offered at either the Scientist or Sr. Scientist levels.
We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Different makes us better.
Due to the highly regulated pharmaceutical industry and legal requirements, you may be subject to post employment background checks.