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CareersThe Louisiana Gene Therapy Research Consortium Clinical Manufacturing Facility anticipates having positions available in three departments: Quality Assurance & Control, Facilities, and Production. We will begin accepting resumes in June 2009. QUALITY ASSURANCE AND CONTROL Quality Assurance - Document Control - Issues batch records (BPRs) collects and consolidates completed BPR and analytical release results for product. Controls distribution and changes associated with SOPs, SMPs and SAPs. Typically has a 2 year degree with 2-4 years of experience in a cGMP manufacturing/pilot operations work environment. Quality Assurance – Raw materials/Batch Records - Reviews records and data for the release of raw materials and product. Typically has a 4 year degree with 1-3 years pharmaceutical experience. Quality Control – Microbiology - Establishes and manages the environmental monitoring program for the CMF. Typically has a 4 year degree in microbiology with 3-5 years pharmaceutical experience. Quality Control - Stem Cells - Tests materials used in the production of stem cell products against quality release standards prior to their use in producing a pharmaceutical. Typically has a 2 or 4 year degree in chemistry or microbiology with 1-3 years pharmaceutical experience Quality Control - Vector Production - Tests materials used in the production of vector products against quality release standards prior to their use in producing a pharmaceutical. Typically has a 2 or 4 year degree in chemistry or microbiology with 1-3 years pharmaceutical experience FACILITIES Calibrations Technician - Establishes the testing criteria and tests instrumentation for the facility and process equipment. Typically has at least a 2 year degree in instrumentation and 2-4 years experience in either the pharmaceutical or the military calibration departments. Equipment/Facilities Supervisor/Technician - Establishes and tracks repairs and maintenance of facility and process equipment under SMPs. Typically has at least a 2 year degree in equipment maintenance with 3-5 years experience in the pharmaceutical industry. Materials Supervisor - Establishes the receiving and distribution (quarantine and release) guidelines for incoming and outgoing components /ingredients /product. Typically has at least a 2 year degree with 2-4 years experience in the pharmaceutical industry. Janitorial - Works closely with production organization in the cleaning and sanitation of the facility as well as the general facility. Two to 4 years of experience in the hospital of pharmaceutical industry preferred. PRODUCTION Vector Production Manager - Schedules personnel and supplies for the production of vectors carrying the DNA needed for the disease treatment. Understands, follows and teaches the CFR guidelines for the production of pharmaceuticals by creating /using BPRs and SOPs. Typically has a BS degree in chemistry, microbiology or other scientific discipline with 5 years pharmaceutical experience. Technicians - Produces pharmaceutical products using BPRs and SOPs. Has a 2 year degree in Microbiology/chemistry or laboratory sciences with 0-3 years pharmaceutical experience |
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