Federica Airoldi Email and Phone Number

• Handling of API complexities• Discussion with outsourced vendor /supplier for different technical (eg.Process, Specs definition, changes) & timeline aspects to drive the projects forward• Provide audit support• Organize, schedule, and facilitate crossfunctional team meetings between API vendor & different teams like API sourcing, API RA & Formulation Development teams to understand the requirements & exchange information & identify risks

Main Activities:• To approve or reject batches of raw materials (NCE), bulk and finished products (IMPs), from the development to the clinical testing phases, performing a critical evaluation of the test results.• To select, evaluate and manage Vendors entrusted for outsourced activities concerning release and stability testing relevant to NCE and IMPs, analytical methods development and validation, to evaluate compliance with regulatory requirements and internal standards.• To manage stability protocols/studies and stability results performed externally through revision, approval and involvement in OOS/deviations. To provide support to stability studies performed internally, when required.• To ensure proper filling of documents and samples pertaining. • To maintain and continually evaluate/improve quality process and systems, including methods development and validation, through interactions/coordination with appropriate functions, internally and externally.• To attend Vendors’ Audit as responsible for internal assessment.• To prepare and/or approve SOPs relevant to the activities carried out by Analytical Development, within the R&Q function.• To set and negotiate priorities of work projects.• To provide support to the compilation of quality sections of regulatory documentation (e.g. IMPDs, INDs).

In collaboration with the Formulation team, evaluation of API stability through the planning of stability testing on different formulations (O/W emulsions, suspensions, freeze-dried products). Use of HPLC-UV (Chemstation Software), UFLC-MS (Analyst Software), FT-IR, K.F.Within the Analytical team, optimization/validation of analytical methods.Provide authorship of technical reports and reviewing Standard Operative Procedures.Maintenance and calibration of Laboratory Equipment to meet GLP standards.

Support to the Synthesis group in the process of lead discovery and lead optimization through the identification and the evaluation of the purity of synthesis intermediates and finished products. Use of HPLC-UV-MS (Xcalibur Software), GC-MS, UPLC-MS (MassLynx Software).

Evaluation of enzyme activity (lipase, amylase, protease) of pancreatin capsules. Use of titrator, HPLC-UV, UV spectrometer, dissolution baths.

Assistant in the analysis for the evaluation of the stability of new chemical entities in simulated gastric/intestinal juices. Use of UPLC-UV-MS, HPLC-UV, SEC.