R&S > Activity, Resources & Work Philosophy
The F.I.S. R&D Group is combining creativity and efficiency of operations while managing API manufacturing projects. With research and development in our foundation we are every day engaged in succeeding in projects with challenging organic chemistry and analytical development based activities aimed at developing and industrialized robust processes of active pharmaceutical ingredients.
- 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.
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, F.I.S. 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)
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).
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 F.I.S. 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.