lead the Application Development team in creating customized applications to enable new technologies for the Cell and Gene therapy.

*Translated existing manual process into automated processes on the CliniMACS Prodigy platform.*Actively assisted clients with process development and optimization as a technical expert of the CliniMACS platform.*developed customized application for automated acquisition and analysis of flow cytometry samples using statistical methods.* trained junior team members of the team

- Led the laboratory through method validation following FDA FVM Program guidelines (HPLC-DAD, LC-MS/MS, GC-MS/MS, ICP-MS, GC-FID, HS-GC-FID and microbial plating).- Obtained the license from the Bureau of Cannabis Control to test cannabis and cannabis products for compliance with California State regulations.- Helped getting the laboratory approved for Industrial Hemp Verification testing in more than a dozen California counties- Maintained the laboratory ISO 17025:2005 certificate and upgraded the laboratory quality system to the 2017 standard.- Acted as a liaison for official communications with state entities (CDFA, BCC).- Oversaw laboratory daily activities ensuring smooth operations, fast turn around time and adherence to company policies- Communicated with existing and prospective clients in a professional manner to enhance company image.- Responsible for hiring, training, retention and termination of laboratory personnel.- Trusted with developing and selecting new methods and technologies to expand or improve the laboratory offered analysis.- Assisted other laboratory locations with method development and validation, collaborating with local management team.

♣ Managed laboratory personnel and workflow to balance the needs of both fast and accurate analysis and ensure the adherence to laboratory SOPs, GLP and all applicable laws and regulations.♣ Achieved the initial ISO/IEC 17025:2017 accreditation for the laboratory with zero NCR.♣ Scientifically developed, optimized and validated analytical methods (for HPLC-UV/Vis, HPLC-MS/MS, GC-FID, and PCR) and sample preparation techniques following a continuous improvement approach, employing Design of Experiment and statistical analysis.♣ Ensured all analytical instruments were calibrated and correctly maintained and operated.♣ Reviewed analysis data and authorized the release of analysis batches.♣ Authored and reviewed all laboratory SOPs and generated CAPA/OOS as appropriate.♣ Developed a shared file to keep track of customer complaints and efficiently pinpoint recurring issues in order to aid in the individuation of analysis or techniques that need improvement and promptly initiate CAPA.♣ Streamlined the internal data sharing system moving from a paper-based “push” approach to a computerized “pull” approach, reducing the likeliness of clerical mistakes.

♣ Coordinated daily laboratory operations managing and training junior staff members, assigning tasks and escalating issues to management when warranted.♣ Organized laboratory workflow to deliver a timely release of batch analysis and uphold the laboratory fast turn-around commitment.♣ Prepared and analyzed samples to screen for trace amounts of residual solvents and pesticides and to define the sample chemical profile following laboratory SOPs, GLP and ISO/IEC 1725:2005 standards.♣ Independently reviewed analysis data and decided whether the samples needed further analysis or could be sent to the Laboratory Director for final approval and release.♣ Led the analytical method development and validation for HPLC-UV/Vis, LC-MS Triple Quadrupole, and Headspace GC-FID.♣ Developed a new HPLC method that allowed to reduce analysis time by 30% while increasing peak resolution.♣ Systematically reevaluated sample preparation and analysis techniques to continuously improve laboratory procedures.♣ Authored and reviewed all laboratory SOPs and generated CAPA/OOS as appropriate.♣ Verified that all laboratory equipment is correctly maintained, calibrated and ready to use and that all quality control logs are updated as specified in the respective SOPs.♣ Maintained the laboratory stocked updating the inventory and dispatching the appropriate supply request forms.

The main focus of my PhD studies was to develop microfluidic-based technologies to study the mechanosensitive response of cardiovascular cells cultures focusing specifically on cells alignment and polarization and on mechanical strain. During the three years PhD project I've:- optimized pre-existing patterning techniques for glass surfaces- established new patterning techniques for elastomeric (i.e. PDMS) surfaces- developed stretching systems that address different biological assaysThe developed technologies are currently being used in the laboratory to investigate the biological response of aligned human cardiomyocytes to mechanical strain.

Provided guidance to the students during the laboratory experience and homework assignments of the M.Sc. course in Multiphase Thermodynamics and Transport Phenomena

The goal of the collaboration with Prof. Belmonte laboratory was to investigate the role of mechanotransduction during differentiation and aging of Vascular Smooth Muscle cells.During my visiting experience I've:- learned how to independently maintain hESCs and hPSCs and differentiate them to vascular progenitors and VSMCs.- set up a microfluidic stretching system (designed and developed in Padova) to allow cyclic mechanical stimulation of cultured cells.- performed experiment to investigate the effect of physiological mechanical stress during the differentiation of vascular progenitors to VSMCs, showing a 4 fold increase of differentiation rate in the presence of mechanical stimulation.- compared the response to mechanical strain of healthy and senescent cell lines using biological models of accelerated aging, showing that in the senescent niche the mechanotransduction response is impaired.

"Optimal management of a microfluidic platform for the analysis of ex-vivo tissues of diabetic patients"Developed a matlab routine integrated with COMSOL multiphysics simulation to analyze the endogenous/exogenous factors's concentration profile in a microfluidic channel during batch-fed conditions