• Manufacturing Management/Oversight
• Equipment & Process Validation – Planning & Implementation
• Equipment Development, Procurement, Fabrication
• Process (Technology) Transfer
• Process Development
• Project and Technical Management
• Technical support for CMC Regulatory submissions

Strategic

·         Project planning & budgeting

·         Process Development staffing and organizational design

·         Manufacturing & development due diligence reviews

Infrastructure Development

·         Candidate reviews for key positions

·         Development of internal systems (e.g., Validation Program, Process Validation Program)

·         Development of internal Guideline documents (e.g., Guidance for Process Development)

Other

·         Training

·         Networking