Senior Site Manager, Drug Product Steriles, CMO
Genentech, Inc. - Greenville, NC

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Passionate About Science
We're passionate and rigorous about our science. For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using innovative science to develop breakthrough medicines that improve the lives of people with serious or life-threatening diseases.

The following opportunity exists in our Greenville, North Carolina headquarters:
Senior Site Manager, Drug Product Steriles, CMO

Responsibilities:
This Site Manager will manage the Production oversight related to sterile drug products manufactured at a Contract Manufacturing Organization (CMOs) located in Greenville, North Carolina. This person will be a team leader on a CMO governance team to support right to operate and supply of critical biologic products, including a product launch. He/she will manage the lifecycle of contract manufacturing activities for commercial products at one or more bulk drug product (DP) third-party contract manufacturing organizations (CMOs), including CMO selection, process technology transfer, routine cGMP manufacturing, and site decommissioning upon completion of the contract. The candidate will establish and manage business, operations, and quality relationships and communications between Roche/Genentech and the CMO as a point of contact for the contract manufacturing relationship at the Joint Management levels. He/she will lead cross-functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve CMO site business, operational and quality objectives, plans, and performance goals. The candidate will provide the single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CMO site governance structure.

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