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

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

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