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: Will assist in the production, development and maintenance of mammalian cell banks under cGMP, used for clinical and commercial manufacturing of biologics. The candidate will further execute upstream protocol driven, lab-scale studies, analyze data and author technical reports for PAR studies.
Essential Duties and Responsibilities may include, but are not limited to, the following:
* Performs technical investigations and creates associated reports.
* Develops and writes responses for technical sections of Regulatory documents.
* Conducts scaled-down production procedures to improve the efficiency and yield of candidate or existing bioprocesses.
* Carries out small-scale process validation studies.
* Assists in the analysis of samples generated from lab scale studies.
* Develops and writes protocols for small-scale process validation studies.
* Tabulates results and writes summary reports of process evaluation and validation studies.
* Presents findings at group and possibly at interdepartmental meetings.
* Maintains lab supplies and equipment.
* Produces and maintains accurate records.