Melissa Enste Email & Phone Number

Lewes, Delaware, United States

Frederick, Maryland

• Maintain kanban ordering system for floor stock inventory “supermarket”• Operate qualified equipment within a cGMP laboratory at a VPP certified facility• Train coworkers in varying processes and equipment as well as assist with onboard training of new hires• Participate in practical process improvement initiatives through kaizens, and as a 5S and safety leader• Perform gemba walks and audits of lab areas to ensure safety, lean production, and continuous improvement• Organize red tag collection and removal of all non-essential materials and equipment• Report hazard IDs, near misses, and incidents into tracking system to improve overall site safety• Work with procurement department to right size materials, utilize cost effective PPE, and maintain recycling of PPE to drive cost saving initiatives• Perform formulations of varying complexity in a timely manner• Assist in the staging of materials for future formulations• Collaborate among departments on production schedule to avoid backorder and component expiration while utilizing equipment and laboratory availability• Complete documentation while maintaining good documentation practice (GDP)• Aid in the document writing, validation, and pilot runs of new products• Assist with filling, capping, and labeling using precision liquid handling tools and processes• Attend and lead tier meetings to align company priorities and communicate escalations• Organize and execute operations wide teambuilding activities• Liaison between core team and floor operations for new product initiation• Participate in cross-function RCCM meetings for non-conformances, process and safety gaps, and corrective actions• Provide continuous feedback to and from management and lab employees• Contribute to hiring process for contract employees• Initiate document updates and change controls to align processes and implement corrective actions

Hunt Valley, Md

• Project assistant for internal MDI development program covering formulation development and analytical testing• Aided in the development and scale up of a rescue inhaler formulation to registration batch scale• Reverse engineered marketed MDI products• Developed analytical methods, guided, and ran internal validation processes working in conjunction with technical writing and validation groups• Maintained supplier relationships for specialty device components• Developed specifications for release of incoming materials and the development of SOPs for equipment• Operated and maintained qualified equipment within a cGMP environment• Procured and validated equipment for use within a cGMP environment• Collaborated among departments on equipment training• Monitored and organized stability testing among multiple departments• Initiated change controls for test methods

Hunt Valley, Md

• Operated and maintained qualified equipment within a cGMP environment• Maintained a 500+ chemical inventory• Ran internal UV-Vis validation processes working in conjunction with technical writing and validation groups• Supported formulation development within research and development• Analyzed excipients, active pharmaceutical ingredients, and finished products throughout manufacturing• Efficiently trained new hires

Columbia, Md

• Evaluated commercial and developmental Fluid Cracking Catalysts• Operated and maintained ACE (Automated Catalyst Evaluation) unit and LECO carbon analyzer• Prepped equipment for efficient transfer of shifts