Dendreon Corporation

Compliance Specialist II

Dendreon Corporation (Nasdaq: DNDN) is a biotechnology company whose mission is to target cancer and transform lives through the development of innovative cancer treatments. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon's product pipeline also includes monoclonal antibody and small molecule product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp.

We are seeking a Compliance Specialist responsible for GMP validation and change control activities and may assist with Quality activities in the QA department.

Description:

• Review and approve validation plans, protocols (IQ, OQ and PQ) and final reports for Facilities, Equipment, Processes, and Computer Related Systems within the guidelines of cGMP and internal policies.
• Complete risk assessments, as necessary.
• Work with QA to track and coordinate any validation deviations, change control and/or corrective actions.
• Create corporate standard operating procedures (SOPs) for software validation that follow GAMP 4 validation life cycle.
• Responsible for communicating validation approach and requirements to internal customers and external contractors.
• Create standard operating procedures (SOPs) for Facilities, Equipment, Processes, and Computer Related Systems corporate Change Control Program.
• Administer the programs for Facilities, Equipment, Processes, and Computer Related Systems Change Control.
• Perform audits of back up, restore, disaster recovery, and security documentation and procedures.
• Support the Dendreon QA/Compliance department in any regulatory inspections or audits.

Requirements:

• Bachelors degree in Science, Engineering, or equivalent with 3-5 years in commercial biopharmaceutical manufacturing or quality assurance environment preferred.
• Understanding of process validation principles, establishment of critical parameters and acceptance criteria is desired.
• Thorough knowledge of cGMP and applicable FDA regulations.
• Extremely detail oriented with a focus on quality, metrics, and process improvements.
• Willing to travel up to 30% of the time with extended stays at various sites.
• Must be detail-oriented team player with excellent written & oral communication skills.

Working Conditions and Physical Requirements:

• The job is performed in a normal office environment.
• Physical requirements include ability to operate a personal computer, automated office equipment, and to work at a desk for long periods of time with frequent opportunity to move to other locations within the building.

The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.

We offer a competitive compensation and benefits package, including bonus, matching 401(k) & stock options. Please visit www.resourcehire.com/clients/Dendreon/publicjobs/controller.cfm to submit your resume.

Dendreon Corporation
Reference Job Code: 4869

Dendreon Corporation is an Equal Opportunity Employer

Submitted: 02/15/2006