Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: Within the Combination Products Applied Research team, support usability studies and functional testing for combination product development.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Work with internal departments to coordinate and manage usability studies, including exploratory studies, formative studies, and summative (Design Verification) studies.
* Author test protocols, reports, summaries and other technical documents.
* Perform small-scale development and assembly of suitable components for usability studies and functional testing, including substitute drug product, manual filling, manual device assembly, labeling, and packaging.
* Develop understanding of human factors/usability testing and the application to design controls.
* Occasional work involving execution of testing in the Combination Products Laboratory.
* Maintain accurate laboratory notebooks.
* Follow Standard Operating Procedures (SOPs) and comply with applicable regulations and Current Good Manufacturing Practices (cGMPs).