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.
Associate Scientist / Scientist determination is based upon level of experience and education.
The person in this role provides technical support to assigned projects, using robust scientific methods which comply with standard operating procedures and scientific standards. Works with limited direction and as appropriate, may serve as a project leader to manage analytical support for projects with supervision.
Key Responsibilities include:
- 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.
- Attend and present data at project-related meetings, interact with other departments and outside testing laboratories to ensure proper analytical testing.
- Training of other scientists
Bachelors of Science degree; Typically a minimum of 2-4 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), atomic absorption spectroscopy, ICP-OES, ICP-MS, 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
Equal Employment Opportunity/M/F/disability/protected veteran status.