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Job ID: 4553
Employer: Genentech
Position: Senior IMP Quality Product Steward Small Molecules
Description: For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to develop novel medicines for serious and life-threatening diseases. Now a wholly owned member of the Roche Group, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset.
The following opportunity exists in our South San Francisco, CA, headquarters:
Senior IMP Quality Product Steward Small Molecules
Responsibilities:
The Senior IMP Quality Product Steward Small Molecules will be responsible for product quality and the single point of contact for the GMP quality organization for small molecule products. The Quality Steward oversees every aspect of the GMP quality system throughout process development and regularly receives and provides input and feedback from site and corporate Quality groups regarding product quality. The individual is the GMP quality decision-maker for product-impacting decisions such as product specific change requests and the outcome and CAPAs associated with product-impacting investigations. He/she approves the shelf life and specifications for the products and drafts, approves and maintains product specification files. In addition, the incumbent captures relevant technical information, regulatory inputs, as well as considerations for cross-project consistencies and oversees the quality aspects of combination products like devices. The individual will initiate, champion and drive quality projects and act as advisor to senior management.
Requirements: This position requires a Bachelor’s or Master’s degree in science or a technical discipline and at least 15 years of experience in pharmaceutical companies with at least five years of experience in Quality. A PhD is preferred. The ideal candidate will be a recognized leader who leads others especially in the times of uncertainty and an effective communicator of ideas which have a major impact on directives and goals. The applicant must have at least three years of increasing management responsibility or consulting experience. He/she must be knowledgeable of US, Canadian, EU and ROW regulatory requirements applicable to development and production of bulk recombinant proteins, combination products, including devices to be used for clinical trials.
Genentech is dedicated to fostering an environment that is inclusive and encourages diversity of thought, style, skills and perspective. To learn more about our current opportunities, please visit: http://careers.gene.com and reference Req. #1000032812. Please use “Web – CACO” when a source is requested. Genentech is an equal opportunity employer.
Location: South San Francisco, CA
Contact: http://careers.gene.com
Post Date: 6/29/2010 1:28:29 PM
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