Assoc. Manager Drug Product Investigations

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POST DATE 9/1/2016
END DATE 10/23/2016

Regeneron Pharmaceuticals, Inc. Rensselaer, NY

Company
Regeneron Pharmaceuticals, Inc.
Job Classification
Full Time
Company Ref #
360567
AJE Ref #
576051725
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. /p p Summary: Manage investigation of process variances involving aseptic filling, container closure materials and manufacturing, and delivery device performance and manufacturing. br / br / Essential Duties and Responsibilities include, but are not limited to, the following: br / * Management of deviations encountered during aseptic filling at contract manufacturers. br / * Management of deviations encountered as a result of inconsistencies in primary container and closure manufacture. br / * Management of deviations encountered as a result of inconsistencies in delivery device performance and manufacture. br / * Provide technical leadership to internal and external groups in order to complete deviation investigations and disposition of supply. br / * Maintain strict adherence to quality system metrics targets and cycle time goals. br / * Propose standardization and business process improvements in order to increase efficiency and timeliness deviation investigation closure. br / * Provide regulatory filing support for drug product (IND, BLA, MAA, etc.) as well as support during regulatory inspection of site quality systems. br / * Monitor changing regulatory requirements, industry standards, and best practices for filling, delivery devices, and packaging. Ensure developments are communicated within the company and appropriately implemented. br / * Technical liaison between Regeneron Quality Control, Quality Assurance, Operations/Logistics Departments and contract manufacturers or business partners. br / * Maintain required training status for staff on Regeneron specific work instructions and SOPs. br / * Travel to manufacturers or business partners, as required. br / br /