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Description
About Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 60 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology and hematology. If youd like to join a company where you can make a difference, please consider the Celgene family.
Prerequisites
B.S. in Biochemistry, Biology, Biomedical Engineering, or related discipline
Summary
The primary responsibility of this position is the transfer, validation and performance of bio-analytical assays and the associated data analysis and reporting for the clinical production of cell therapy products.
Responsibilities will include, but are not limited to, the following:
Essential DQC tasks include:
Perform in-process and final product release testing of PDA001.
Perform and report on the stability testing of clinical and pre-clinical cellular therapy materials
in support of PDA001.
Coordinate and execute the send out and receipt of PDA001 test samples.
Assist in development and transfer of bio-analytical assays as they relate to the clinical
development of PDA001.
Develop and coordinate in-house proficiency testing for appropriate bio-assays.
Develop databases needed for the tracking and trending of DQC and clinical production
information.
Train personnel of the use of developed databases.
Participate in equipment, method or process qualifications/validations.
Draft and implement SOP using Change Control system.
Submit, investigate and close out Non-conformances and CAPA as needed.
Perform routine calibration and maintenance of DQC instruments and equipment.
Perform other duties as needed.
Skills/Knowledge Required:
Required:
B.S. degree (or equivalent) in Biochemistry, Biology, Biomedical Engineering or related
discipline
Desired:
5+ years in a Quality Control laboratory
Experience with aseptic processing and bio-analytical assays
Beneficial
Cell culture and/or analytical methodology experience
2+ years of device, biologics or HCT/P industrial experience
Proficient in Microsoft Word/Excel/Access
Equal Employment Opportunity
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employees temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the at-will employment relationship between the employee and Celgene.
Details:
Job Id:
18259457
Posted / Updated:
2/24/2011 3:42:47 AM
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