Francesco Saverio Caldarelli Email and Phone Number

- Management projects based on strong technical competencies; monitoring the achievement in comparison with the defined milestones. - Support to cross-functions (QA, QC, R&D, regulatory, etc.), planning, checking and execution (targets, deliverables, timeline, costs and constraints), lifecycle management and product due diligence. - Attitude to develop a cooperative and positive environment.- Offers formulation and sales contract negotiation. Marketing and business development in agreement with the Managing director. - Manages the agents and mediators in agreement with the customer service manager.- Overviews set up of serialization process between CMO, customers and third parties.

- Development synthesis to produce APIs/High potency APIs within GMP guidelines for clinical use; internal pipeline and custom synthesis (CRO/CMO). - Manufacturing of generic APIs for third parts. - Study of early process feasibility and development of synthetic routes from lab and macro-lab scale to kilo lab. - Implementation of novel technical solution to address scale-up issues (impurities profile, hazard, etc.). Focus on the oncology therapeutic area. - Manage relations with customers and interdisciplinary groups for technology transfer and documentation assembly.

- Working closely with plant responsible, technician and QC people to ensure maximum output levels and the efficient running of the production facility. - Estimating production cost reports for senior managers. Defining critical parameters and robustness on GMP processes. - Transfer technology of GMP processes to CMOs. - Attending weekly progress meetings with other members of the process R&D team. - Coaching and overviewing hydrogenation plant operations. Managing hydrogenation facilities and hydrogenations on kilo scale. - Attending process safety reviews as necessary and making sure that all agreed recommendations are adhered to. - Troubleshooting to plan new synthetic routes, synthesis of impurities, studies of robustness. - Supervising new synthetic routes scale-up from lab to pilot plant of external synthetic projects. - Finding alternative ways to develop and produce and identify new chemical entities.

- New synthesis development for oncology focused API. In particular anthracyclines chemistry.- Process development and optimization of catalytic reactions. - Identification and characterization of by-products and impurities by means of chemical and phisical methods. - Purification methods development (preparative HPLC).- Daily use of common analytical techniques and databases.- Handling of cytotoxic and very potent drugs preparation in glove-box and high containment areas. - Scaling up GMP preparation of cytotoxic and very potent drugs. Issuing of batch records and validation protocols. - Issuing of documentation and reports in Italian and in English.

- New synthesis development for oncology focused API. In particular autoclave reactions.- Transfer from lab scale to plant scale of hydrogenation reactions.- Available methods evaluation, literature search, process development and optimization. - Identification and characterization of byproducts. Purification methods development- Daily use of common analytical techniques (HPLC, NMR, HPLC-MS), and databases (SciFinder, ISIS-Base, Chemtools, MDL data-bases)

- Synthesis into glove-box of cytotoxic molecules for pre-clinic tests.- New synthesis development for oncology focused API. In particular polypeptides chemistry.- Purification and caracterization of new chemical entities .- Literature search, process development and optimization.

- Preparazione e sviluppo di ß-lattami.- Technology transfer all'impianto di produzione.

- Sintesi e preparazione di ß-lattami