| Job Description | Description:
Analytical Specialist
If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals -- it's time to consider Regeneron.
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA (R) (aflibercept) Injection, ZALTRAP (R) (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST (R) (rilonacept) Injection for Subcutaneous Use. Regeneron has filed a regulatory application with the U.S. Food and Drug Administration (FDA) for a second indication for EYLEA. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.
Summary:
Support the Manufacturing, Process Sciences (PS) and Quality Control (QC) departments through the routine execution, development, optimization, validation, transfer and application of analytical test procedures.
Essential Functions:
Essential Duties and Responsibilities include, but are not limited to, the following:
'Perform routine stability and release chemistry and biochemistry testing for pre-clinical and early clinical phase programs (Wet Chem, HPLC, CE)
'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.
'Perform assay qualification/validation experiments.
'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.
Experience:
Knowledge and Skills:
'Chemical principles;
'Analytical chemistry (chromatography, electrophoresis and UV/Vis spectrophotometry);
'Protein chemistry;
'General knowledge of cGMP
'Interpersonal, oral, and written communication skills;
'Word processing, spreadsheet, database management, statistical analysis, graphing, and presentation software.
Requires BS/BA in Chemistry, or Biology; 3-4 year's experience. May consider another degree discipline or position level with commensurate experience; cGMP experience is desirable.
We offer a competitive compensation and benefits package including stock incentives, 401k with company match, as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business. |
| | Company | | Regeneron | Job Code | | State or Province | | New York | | |
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