Masters level research/manufacturing chemist with 8+ years laboratory experience; 2+ years experience in research medical device GLP/GMP environment, 4+ years experience in GLP/GMP manufacturing laboratories using cell culture and aseptic techniques Experienced in the development of GLP analytical methodologies to support the solid-state characterization of formulations for convergent device products Good general industrial process knowledge and experience with cGMP manufacturing and large-scale production Experience in analytical testing utilizing a variety of biochemical, molecular, and cell biology techniques Responsible for applying analytical methods to support root cause manufacturing process investigations for convergent device products Technical writer of process investigation reports, SOPs and method validation reports Experienced in GMP/GLP compliant laboratories. Knowledgeable of FDA, EPA and OSHA regulations Certified in GLP procedures Experienced with Minitab, Unscrambler, GRAMS, Isys spectral imaging software, SigmaPlot, Mathcad, x-shell, Microsoft windows, and Microsoft office Experienced in working with cross-functional and multi-disciplinary teams
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