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Data Analyst
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Country: USA
Location: New Jersey-Central Branchburg, NJ 08876
Total applied: 40 Job Category:Biotech/R&D/Science
Location:Branchburg, NJ 08876
Occupations:General/Other: R&D/Science
Career Level:Experienced (Non-Manager)
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Data Analyst
Company OverviewImClone Systems is dedicated to developing and commercializing novel therapeutic products in the field of oncology. Our efforts have resulted in a broad spectrum of innovative product candidates with potential application in multiple tumor types. As a member of the oncology community, we are committed to providing treatments to meet the unmet needs of cancer patients. To fulfill this commitment, ImClone Systems fosters integration of the principles of teamwork and scientific integrity into all facets of the Company's activities. We believe that these values will benefit patients, physicians, and our employees while creating value for our shareholders. HistoryThe Company was founded in 1984 and in 1986, opened its laboratories at 180 Varick Street in New York City. In its early years, the Company focused on immunology-based diagnostics and infectious disease vaccines. This focus resulted in two FDA approved diagnostics and several vaccine research programs, all of which have been licensed to pharmaceutical companies. During the early nineties, the Company's focus shifted from diagnostics and infectious disease to the development of a pipeline of innovative, biologic compounds in the area of oncology. From this pipeline, three investigational monoclonal antibodies are being evaluated in various stages of clinical development. OperationsImClone Systems operates in two locations - its corporate and scientific headquarters at 180 Varick Street in New York City, which houses the Company's research and executive offices, and its campus in Branchburg, New Jersey. The Branchburg facility is home to the manufacturing, product development, finance, clinical, regulatory and quality assurance and commercial operations departments. This position is responsible for data analysis support of the manufacturing operations. This position will report to a Director, Associate Director, Manager or Supervisor in Manufacturing Technology and will interact with the manufacturing, quality assurance and quality control departments. Some interaction with contract producers of ImClone's products may be required. Knowledge of cell culture, purification and support systems is a plus. Spreadsheet and/or database experience a plus.Responsible for supporting manufacturing operations through the performance of the following duties:1. Verifies the accuracy of the data entered into the in-process database by the Manufacturing staff and ensures that all of the data entries are complete.2. Assists with the trending and analysis of manufacturing production data to support: Non-Conformance Events, process validation protocols and reports, comparability and consistency protocols and reports, technical transfer documentation, BLA filings, annual manufacturing summaries for regulatory documentation, etc. 3. Assists with the maintenance of the manufacturing in-process database. 4. Provides in-process data for technical reports supporting technology transfers, deviation/adverse event reporting and process analysis/trending.5. Performs all job responsibilities in compliance with current Good Manufacturing Practices.6. May be asked to support projects in Manufacturing Support & Process Validation Group. 1. BS degree in Chemical Engineering, Microbiology, Biochemistry or Chemistry2. BS with 0-5 years experience or BSE with 0-3 years experience in a GMP production/development environment.3. Where applicable, demonstrated superior performance as a Manufacturing Technologist.4. Experience in fermentation and/or protein purification manufacturing a plus.5. An understanding of current Good Manufacturing Practices a plus. 6. Strong mathematical and analytical skills.7. WORD, EXCEL, PowerPoint, JMP and VISIO experience a plus. 8. Database experience a plus9. Excellent communication skills, both oral and written. RESPOND HERE! Respond immediately by accessing the following dedicated online response form which will allow you to cut and paste your resume. This form will go directly and immediately to the hiring authority for this position. Access the online response form at: http://sh.webhire.com/servlet/resp/rf?jobid=2239811&boardid=749
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