Barr Research (a Division of Barr Laboratories)Research Scientist/Document Controller
Jun. 2002 - Apr. 2004Plainsboro, NJAs a scientist, main responsibilities involved formulating, developing and preparing pre-clinical and Phase I or Phase I/II clinical supplies for transvaginal rings and devices. Performed informal audits of contract labs and vendors prior to Phase I/Phase II contract manufacturing. Prepared the CMC section of several pre-INDs and INDs. Knowledgeable in cGMPs, cGLPs, CFR 21. Performed regular SOP and OJT training for Research/Process Development scientists and technicians. Qualified trainer for laboratory notebook formatting and review. Other responsibilities as detailed below (see Scientist roles under Enhance Pharmaceuticals). As a document controller, responsibilities included creating, implementing and maintaining an R&D-specific SOP and documentation control system, designed to take into account a more accommodating approach designed for research while still maintaining cGMPs. R&D SOPs were comprehensive, covering global and research-specific procedures, document review and approval, health and safety, equipment procedures, specification and test method preparation, IQ/OQs, controlled environment activities, and manufacturing experimental, pre-clinical and clinical batches. The document control system was available in both paper and electronic formats. Primary coordinator between R&D and QA/RA regarding manufacturing and document control activities. Prepared, reviewed and approved SOPs, specifications, test methods, master formulas and batch records, feasibility proposals and studies, IQ/OQ protocols and reports, poster presentations, journal articles and patent draft applications. Handled inventory, control and dispensing of restricted materials.