| Job Description | Job Summary and Essential Functions:
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:
Support the Manufacturing, Process Sciences (PS) and Quality Control (QC) departments through the development, optimization, troubleshooting, validation, transfer and application of analytical test procedures, and clinical product testing as needed.
Essential Duties and Responsibilities may include, but are not limited to, the following:
•Establish, develop, and/or optimize analytical methodology to test the identity, strength, purity, potency and stability of protein products (in-process and final).
•Establish, develop, and/or optimize analytical methodology to test the identity and concentration of impurities (product-related and process-related).
•Establish, develop, and/or optimize analytical methodology to test the identity and purity of raw materials.
•Develop and write protocols for assay qualification/validation studies and analytical SOPs for product testing.
•Perform assay qualification/validation experiments.
•Transfer new or improved control test procedures to customer groups.
•Troubleshoot established test methods used in development and release testing. Provide analytical support in troubleshooting process and formulation problems.
•Perform routine stability and release chemistry and biochemistry testing for pre-clinical and early clinical phase programs
•Assist in the analysis of samples generated from lab scale process studies.
•Assist in product failure or customer complaint investigations
•Assist QC Release group with overflow routine testing
•Tabulate results and write summary reports of assay development and validation studies.
•Present findings at group and possibly at interdepartmental meetings.
•Maintain lab supplies and equipment for GMP compliance.
•Produce and maintain accurate records.
•Write departmental SOPs and provides drafts of proposed test methods to QC.
•Train lower level group members.
Experience and Required Skills:
Education and Experience:
Requires BS/BA in Chemistry, Biology or related field for level I; progressive experience working in a cGMP pharmaceutical environment required for subsequent levels.
May substitute relevant experience in lieu of educational requirement. |
| | Company | | Regeneron Pharmaceuticals | Job Code | | State or Province | | New York | | |
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