Mission

• To develop and validate safe, economically valuable, robust and scalable processes for manufacturing of APIs and pharmaceutical intermediates.
• To focus on supplying customers with a competitive advantage through the investment in innovative approaches in API manufacturing for both generics and originators drugs market.
• To pursue continuous improvement of processes during the entire product life cycle.

Operating Model

Project-Centric operational model – Integration of Process Chemistry and Analytical Development

• To ensure a fast & effective project progression
• To ensure a synergic and concomitant Process Chemistry Optimization and Analytical Development
• To align Analytical Method Development & Validation for Raw Materials, In Process Control, Intermediates, API Batch Release, Potential Genotox Impurities & Cleaning Operations.

Integration of R&D teams and Plant Industriallization Chemists

• To ensure a timely, efficient and effective technical transfer to manufacturing

Structured Project Management Organization

• To ensure a smooth project progression & On Time In Full delivery of projects

Skill-ful staff, Innovation and Front-End Technologies

• Seventy plus highly experienced Chemists in Process R&D and Analytical Development, hundred and fifty highly trained lab technicians
• Proven track record in Innovative, cost-competitive chemistry routes design, IP-Freedom to Operate assessment and implementation
• Continuous improvement and Cost-driven process optimization, development and back integration for key raw materials
• Thorough knowledge in the applications of PAT, Crystallization monitoring technologies, Solid State analysis, Biotransformation and Flow Processes development.

Attitude, Skills, and Capabilities

• Confidentiality protection, FIS is extremely sensitive to customers confidential information and data, that are securely managed
• Integrated project management from feasibility study to the entire project life cycle .
• Consolidated project reporting experience from the initial lab assessment to pilot and commercial process implementation
• Open communication to customer of results, issues and with a proactive attitude in problem solving.
• In-house resources and tools for process hazard evaluation and optimization studies through the application of process modelling software
• Relationships with external contract laboratories for toxicity and flammability testing of isolated intermediates and APIs for safe handling and storage
• In-house resources and tools for the in depth literature search and patent analysis.
• Access to major database for scientific searches (i.e. STN, SciFinder, Reaxys) and business development intelligence (i.e. IMS and Thomson Reuters Newport and Forecast)

Resources
The R&D staff is comprised of about 240 people, to these staff from Pilot Plant units are added

• 36 chemistry project leaders with chemistry degrees or PhD
• 36 analytical development leaders with chemistry degrees or PhD
• 150 lab technicians working in two/three 8h shifts per day
• 7 Project Managers
• 4 Literature search and Intellectual Property Intelligence expert
• 5 assistants for documentation and activity records
• 26 pilot plant operators and manger, working in 3 shifts per day (24h/day).

Organization

The Chemistry and Analytical Leaders and lab technicians are organized in 18 different R&D Units each one of these made by 12 scientists. Each unit can manage up to 4 projects in different development phase (from the synthetic route design upto the process optimization/development, implementation/validation on a multi-Kg production).

Globally the R&D Group at FIS handles yearly 40-45 projects, 10-12 of these are full validation campaigns, study/optimise and develop about 200 different reactions per year, 150 isolated steps and about 90 of these are transferred successfully into manufacturing every year.
The R&D Group growth by 200% in the last 5 years.