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: Supports the Manufacturing and Process Sciences Departments through the laboratory optimization, troubleshooting and validation of manufacturing bioprocesses.
Essential Duties and Responsibilities may include, but are not limited to, the following:
*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.
*Performs cGMP cell banking.
*Presents findings at group and possibly at interdepartmental meetings.
*Maintains lab supplies and equipment.
*Produces and maintains accurate records.
Knowledge and Skills:
*Interpersonal, oral, and written communication skills;
*Word processing, spreadsheet, database management, statistical analysis, graphing, and presentation programs.
*cGMP operations and large-scale equipment.
*Knowledge of IPC strategies and execution of validation support packages is beneficial.