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QC Manager-In-Process Laboratory Operations
| Details |
Country: USA
Location: CA Vacaville
Total applied: 31
Job Type: Employee
Job Status: Full Time
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QC Manager-In-Process Laboratory Operations
For 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to discover, develop, commercialize and manufacture biotherapeutics that address significant unmet medical needs. We are currently seeking a QC Manager for our Vacaville Manufacturing site.
Genentech?s Vacaville, Calif. site is located on 100 acres, approximately 50 miles northeast of San Francisco. Acquired in 1994, it was first licensed to produce a biologic in the year 2000. This multi-product facility, which manufactures bulk biopharmaceutical products, has approximately 700 employees working in manufacturing operations, quality and administrative services. Currently, the Vacaville facility is undergoing a major expansion. When it is completed, it will be the largest biotechnology manufacturing plant of its kind in the world.
Responsibilities:
The candidate will oversee the daily operations of the Vacaville In-Process Quality Control Laboratory. The Vacaville QC In-process group performs a variety of analytical and bioanalytical techniques supporting the manufacture of mammalian cell derived proteins. Areas of responsibilities include directing a 24x7 laboratory operations, staff development (39 employees), partnering with internal and external collaborators and exerting influence in the development of objectives and long range goals. The candidate will provide technical review and approval of in-process data and laboratory investigations, as well as review and approve controlled documents. He/she will manage the operational budget and deploying strategies to reduce cost variations and support internal and external regulatory inspections. The candidate will monitor laboratory operations through the use of meaningful performance metrics in order to effectively drive process improvements. He/she will maintain strong partnerships with manufacturing and other customer groups to meet operational and commercial initiatives.
Requirements:
A B.S./B.A. degree in Chemistry, Biochemistry, Microbiology, or other related scientific discipline and at least eight years of experience in the pharmaceutical/biopharmaceutical industry is required. The candidate must have at least five years of supervisory experience with increasing span of control. He/she will be an experienced leader with demonstrated strategic agility and the ability to execute designed strategies and goals. Excellent communication, problem solving and interpersonal skills are required. In addition, the candidate will have the demonstrated ability to make sound and timely decisions in the face of complex issues and problems. Working knowledge of Quality Systems and Quality Control concepts, including the application of current Good Manufacturing Practices (cGMPs) is required.
This position is located at the Vacaville facility and is a Monday through Friday day shift position and may include evening, weekend, or holiday hours as needed to support operations.
Genentech offers one of the most comprehensive benefits packages in the industry. Our culture emphasizes working hard, collaborating and sharing rewards. With a long history of helping busy people with busy lives, Genentech offers employees an array of outstanding benefits, including concierge services, on-site dental, take-out meals and sabbaticals. You can apply by visiting our website at www.gene.com/careers; reference Requisition #1000014167. This will allow you to create an account and store a resume for application to Genentech positions. Genentech is an equal opportunity employer.
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