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Dendreon Corporation
Quality Control Supervisor (Bioassay) - Alternate Shift
Location: Morris Plains,
New Jersey-Northern
07950
Posted on:
9/29/2009 12:08:04 PM
Postion type:
Full time
Job Code:
5782
Required Education:
NOT PROVIDED
Salary:
DESCRIPTION
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. The Company applies its expertise in antigen identification, engineering, and cell processing, to produce active cellular immunotherapy product candidates designed to stimulate a cell-mediated immune response. Dendreon is traded on the NASDAQ Global Market under the symbol DNDN.
Dendreon is seeking a Quality Control Supervisor in our New Jersey Quality Control Department. The Supervisor for the bioassay group, is responsible for the supervision of the various bioassay performances, trouble-shooting and smooth lab operations on a daily basis as well as during inspections/audits by the FDA and other regulatory agencies. The ability to provide leadership, function in a fast-paced, highly technical environment, supervise competing priorities, ensure the first-time quality, and communicate effectively with teammates and manager is essential to success.
General Summary:
• Assists with the management of daily operations in the Bioassay Laboratory.
• Responsible for raw materials, in-process and final product testing of products (e.g. flow cytometry, ELISA, endotoxin, complete blood count, viability).
• Responsible for management of test samples, reagents and reference standards used in the laboratory.
• Ensures laboratory data integrity and traceability.
• Communicates with Corporate QC and ensures implementation of harmonized laboratory control systems in the NJ Bioassay Laboratory.
• Provides technical expertise and testing support to other departments as part of cross-functional project teams.
• Trains, develops and mentors reporting staff.
• Set goals, provide performance reviews, and conducts other assigned administrative duties.
• Accountable for adherence to departmental budget.
REQUIREMENTS:
• Bachelor’s degree in a scientific discipline or equivalent.
• Typically 5 years of experience years related experience in cGMP/FDA regulated industry.
• Typically 2 years leadership experience.
• Thorough knowledge of cGMP/ICH/FDA regulations.
• Proficient in MS Office applications.
• Experience with LIMS preferred.
Working Conditions and Physical Requirements:
• Ability to gown aseptically for work in Clean Room environments.
• May be required to work alternate shifts.
• Some travel may be required.
• Extensive use of laboratory equipment, chemicals and biological materials.
Benefits
We offer a competitive compensation and benefits package, including bonus, matching 401(k) & stock options. Please visit http://dendreon.com/careers/ to submit your resume.
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.
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