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 markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Summary: As a potency method (cell based bioassay, binding assay) subject matter expert and leader in the laboratory, support the Manufacturing, Process Sciences (PS) and Quality Control (QC) departments through the development, optimization, troubleshooting, validation, transfer and application of potency test procedures. The ideal candidate will be recent PhD scientist who wants to be a scientific leader in the analytical development and CMC arena.
Essential Duties and Responsibilities may include, but are not limited to, the following:
• Working with research groups in Tarrytown; develop potency assays that are fit for Phase I and Phase II release testing.
• Write SOPs for the potency assays that are developed and provide drafts of proposed test methods to QC.
• Represent Bioassay Development on interdepartmental teams and in meetings. Update senior management as needed on progress and strategy.
• Develop analytical strategy for resolving plant investigations, regulatory inquiries, customer complaints, and OOS/OOT results.
• Design, write, and review protocols for assay qualification/validation studies.
• Evaluate and make recommendations on new instrumentation and technology.
• Lead troubleshooting activities for established test methods used in development and release testing. Provide analytical support in troubleshooting process and formulation problems.
• Assist junior laboratory personnel in establishing, developing, and/or optimizing bioassay methodology to test potency).
• Perform job duties with minimal direction from supervisor. Design scientifically sound studies and experiments being given only a general outline of the study goal.
• Tabulate results and write summary reports of assay development and validation studies.
• Using the available scientific literature, develop scientific arguments for white paper justifications and investigation conclusions.
• Produce and maintain accurate records.
• Transfer methods that are developed to Clinical Potency Testing group.
• Act as a mentor within the laboratory.
• Individual contributor with possibility of supervising an intern.