Project Management
Assist in the Selection of special service providers
Project fundamentals, progress monitoring & reporting
Budget; schedule; process engineering; quality assurance; quality control
Ensure alignment with functional unit & regulatory issues
Oversee the development of a concise program
• Required manufacturing space • Equipment list • Process flow & utilities • Volume of production • Human resources
Factor budgets, cash flow and timelines
Development of operations criteria, manufacturing, & throughput goals
Identify technology
Identify the appropriate technology to meet strategies and objectives
Review and approval
Ensure appropriate review and approval which occurs before implementation of the technology
Establish site
After selection criteria is implemented
Oversee the development of a validation master plan
Development of a concise program
Mini pilot that enables scale-up
R&D for new innovative and Biosimilars products
Training personnel for a smooth technology transfer
Continued support for ongoing projects
Preparation of required documentation
Ensure requirements are met
Lead or assist with Factory Acceptance Testing
Development, execution and/or oversight
Assist in the development, execution and/or oversight of all installation, operation, and process qualification documents and activities