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.
Applies technical expertise and complex methodologies to conduct and/or design experiments in support of product formulation and regulatory submission. Leads and trains analytical colleagues in conducting complex experiments as well as introduction of modern analytical trends/techniques.
- Individually contribute or oversee the creation of new product specifications and test methods which are robust and meet regulatory requirements. Prepare documents for regulatory filings (ANDA, NDA, ANDS). Design experiments, provide data and provide responses to comments on FDA deficiency letters.
- Perform physical and chemical testing on raw material, in-process, finished product and stability samples. This includes documentation and review.
- Individually investigate or lead investigations to successfully resolve analytical problems, project issues and deviations. Accurately maintain all related documentation in compliance with SOPs.
- 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.
- 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.
- Provides technical and procedural training and mentoring for team members and coordinating team member activities to successfully accomplish departmental goals.
- Conduct technical document review for external departments. Approve analytical reports, CofA, specifications, test methods and deviations related to own or other projects.
- Individually contribute or oversee the development, validation and transfer activities associated with non-complex to complex analytical methods.
- Bachelors of Science degree; Typically a minimum of 10 years work experience required. Master of Science degree; Typically a minimum of 6 years work experience required. PhD degree; typically a minimum of 4 years work experience required.
- 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
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.