| Job Description | Description:
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:
As the electrophoresis (SDS-PAGE, CE-SDS, IEF, cIEF, iCE) 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 analytical test procedures
Essential Duties and Responsibilities include, but are not limited to, the following:
'Department Subject Matter Expert in electrophoretic techniques, especially capillary based methods.
'Establish, develop, and/or optimize bioanalytical methodology to test the identity, strength, purity, potency and stability of protein products (in-process and final).
'Establish, develop, and/or optimize bioanalytical methodology to test the identity and concentration of impurities (product-related and process-related).
'Design, write, and review protocols for assay qualification/validation studies.
'Evaluate and make recommendations on new instrumentation and technology.
'Transfer new or improved control test procedures to customer groups.
'Lead troubleshooting activities for established test methods used in development and release testing. Provide analytical support in troubleshooting process and formulation problems.
'Perform job duties with limited direction from supervisor. Design scientifically sound
studies and experiments being given only a general outline of the study goal.
'Conduct in-depth product failure and customer complaint investigations
'Tabulate results and write summary reports of assay development and validation studies.
'Present findings at departmental and possibly at interdepartmental meetings.
'Using the available scientific literature, develop scientific arguments for white paper justifications and investigation conclusions.
'Produce and maintain accurate records.
'Write group SOPs and provides drafts of proposed test methods to QC.
'Train junior level group members and act as a mentor within the laboratory.
'Represent Analytical Sciences on interdepartmental teams and in meetings
Experience:
Knowledge and Skills:
'Biochemical principles;
'Electrophoresis
'Chromatography;
'Analytical chemistry (characterization and validation);
'Protein chemistry;
'Statistical analysis:
'Basic knowledge of quality by design and cGMP;
'Interpersonal, oral, presentation, and written scientific as well as business communication skills;
'Word processing, spreadsheet, database management, graphing, and presentation software.
Requires Ph.D in Biochemistry, Chemistry, Biology or related field, along with at least 1-2 years relevant work experience - preferably in the pharmaceutical or biotechnology industries. Experience with MS, GCMS, LCMS, or ICPMS also a plus.
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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