Hplc Chemist/Lab Safety Specialist (Lab Analyst Ii)
Maplewood, Mn
Extensive content and impurity analysis on UPLC and HPLC, utilizing Empower software. Method development and validation – multi-level and supplemental validations for new and old methods. Trained new hires on: HPLC/UPLC, protocols, specifications, moisture analysis, pH and viscosity testing, myriad laboratory equipment, electronic laboratory notebooks (ELNs), Laboratory Information Management System (LIMS) and working with Active Pharmaceutical Ingredient (APIs). Authored and re-versioned: stability/study reports, methods, specifications and training documentation. Segued into the Process Development Team – utilized injection molding and automated systems to build medical devices and components to ensure start dates for a phase 3 clinical trial were met. Conducted GMP builds in 10,000 and 100,000 level clean rooms, while using isolators (rated to 100 level cleanliness), in accordance with USP and ISO 9001 standards. Aided chemists and engineers with disposal of all classes of chemicals, through proper DOT/OSHA documentation and shipment for incineration. Prepared and conducted hazard reviews for 3M’s Industrial Adhesives and Tape Division (IATD) to ensure mechanical and or chemical hazards were well documented and that proper safeguards were in place to uphold EHS and Industrial Hygiene standards. Performed respirator fit testing for: disposable, half-face and full-face cartridge respirators