Dendreon Corporation

Quality Control Manager

Dendreon Corporation is a publicly held biotechnology company developing therapeutic vaccines, monoclonal antibodies and small molecule candidates for the treatment of cancer and other diseases.

We are seeking a Quality Control Manager to provide leadership and oversight for all internal and outsourced QC laboratory operations responsible for the commercial testing and release of drug substance, intermediate bulk, and finished drug products and stability programs. Experience relevant to medical devices, recombinant protein, and cellular vaccines is highly desirable. Job functions include interfacing with Manufacturing to provide analytical support and ensure successful commercialization. Must have demonstrated ability to coordinate multiple products, projects and third party contractors effectively. Candidate will be responsible for recombinant protein and cellular vaccine quality control testing and stability programs. Oversight of laboratory testing includes assay development, investigations, deviations, and troubleshooting in a technical and managerial role. Furthermore, the successful candidate will develop test protocols, review technical reports, write SOPs, and maintain GMP documentation. Work with QA to implement procedures in compliance with regulatory requirements and maintain statistical data to identify trends that provide for continuous improvement.

Candidate must have an MS/PhD degree in a Biological Science with 8 plus years experience in pharmaceutical/biotech operations including 5 years of QC management experience. Be familiar with technology transfer, CMC sections for BLA, and building a quality infrastructure to support commercialization. Successful candidate will have extensive knowledge and expertise in QC, including analytical development, protein chemistry, stability and cell-based assays. Excellent verbal and written communication skills and the ability to work collaboratively across multiple functional areas is a strong requirement. Previous supervisory experience is required.

We offer a competitive compensation and benefits package, including bonus, matching 401(k) & stock options. For consideration, please email your resume to:

Please include the job title and code 04532 in the subject line.

Dendreon Corporation
Reference Job Code: 04532
Attention Human Resources

Email: jobs@dendreon.com

Dendreon Corporation is an Equal Opportunity Employer

Submitted: 04/27/2004