Experienced director of chemistry process research, scale-up, development, and production with expertise in project planning and management. Implemented supply chain management processes for just-in-time inventory, resulting in annual savings of over 500k. Skilled in DNA/RNA solid phase synthesis, high and low pressure chromatography, conjugation, ultrafiltration, and lyophilization. Proficient in HPLC, UPLC, LC/MS, TLC, and other analytical methods. Implemented quality systems and tracking from raw material control through finished goods for approved therapeutic and materials for Laboratory Developed Tests. Familiar with 21 CFR parts 210 and 820. Strong problem-solving skills. Proficient in MS Office suite, MS Project, and Visio.
Equipment knowledge: Analytical and Preparative scale HPLC systems (Hewlett-Packard 1100, 1090 asnd 1050, Shimadzu 430A, Beckman System Gold, Rainin Dynamax, Waters Delta-Prep 4000, and BioCAD 60 and 250), Fmoc and tboc peptide synthesizers (MilliGen and ABI), rotary evaporators, UV spectrophotometers, peptide/protein sequencer (Milligen), lyophilizers, centrifuges, and DNA synthesizers (Milligen 8750, 8800 and Large Scale Biology PCOS, ABI 3900, MerMade 192, 192X, and 12), OligoPilot I/II.
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