| Job Description | Description:
Manager Process Validation
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: Responsible for all process validation activities required in preparation for late stage clinical and commercial operations. The successful candidate will lead a team of Process Associates and manage all activities to ensure that manufacturing processes are maintained in a validated state. Experience in cGMP operations and process validation is required. Knowledge of IPC strategies and the concept of continuous process validation is beneficial. Candidate will develop validation procedures reflecting best practices in the industry and ensure on-the-floor coverage is provided during process validation campaigns.
Essential Duties and Responsibilities may include, but are not limited to, the following:
'Responsibility for all process validation activities in preparation for late state and commercial operations.
'Identification of process parameters and appropriate ranges to be included in validation.
'Ensure appropriate protocols are in place in advance of manufacturing activities, communicate process validation data in a timely fashion, and ensure all validation activities are fully documented in high quality reports.
'Lead a team of process specialist and manage all activities to assure that manufacturing processes are maintained in a validated state
'Develop validation procedures reflecting best practices in the industry and provide on-the-floor coverage during process validation campaigns.
Knowledge and Skills:
'Process Validation
'Cell culture
'Protein chromatography;
'Interpersonal, oral, and written communication skills;
'Word processing, spreadsheet, database management, statistical analysis, graphing, and presentation programs.
'cGMP operations
Experience:
MS with minimum of 3 years of relevant experience(Associate Manager); Additional experience may be considered toward Manager or Sr. Manager.
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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