Manufacturing Project Associate - Process Sciences/Regulatory

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POST DATE 9/16/2016
END DATE 11/5/2016

Regeneron Pharmaceuticals, Inc. Rensselaer, NY

Company
Regeneron Pharmaceuticals, Inc.
Job Classification
Full Time
Company Ref #
360948
AJE Ref #
576197386
Location
Rensselaer, NY
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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p 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 commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. br / br / Summary: Using Process Sciences, Regulatory Science and project management expertise within the drug development industry, the Commercial Manufacturing Project Associate serves as the commercial manufacturing representative across functions and Regeneron locations, to manage Process and Regulatory Sciences activities within Commercial Manufacturing. /p p Essential Duties and Responsibilities include, but are not limited to, the following: br / * Supports Commercial Manufacturing in all CMC regulatory filing activities and works closely with Process Sciences Support to ensure all operational support is provided and received as required by production timelines br / * Manage timelines in conjunction with Project Management, Operations, and Subject Matter Experts to ensure on time regulatory submissions br / * Perform critical reviews of pre INDs, INDs, IMPDs, and BLAs to ensure a high quality regulatory submission and approval br / * Prepares, distributes & presents project status reports to management br / * Ensures all validation documentation is received by commercial manufacturing, executed and reviewed while maintaining the set timeline br / * Coordination of reports and protocols such as PPQ, LIVCA, Hold time, buffer studies br / * Point person for process validation sampling and timelines for reports and protocols br / * Track and pull data for IPC program br / * Administers effective, accurate, and timely communication across functional areas and Regeneron locations, serving as a primary point of contact for Commercial Manufacturing Process and Regulatory Science related activities br / * Utilizes tools and mechanisms to ensure global alignment of commercial manufacturing's processes, procedure and methods br / * Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations br / * Involved in daily operational activities /p