Pablo Faccinetti Email & Phone Number

Spain

Buenos Aires

Buenos Aires

Buenos Aires, Argentine

Creation and set up R&D Department in Argentina for a brand-new R&D Plant (2600 m2) including:R&D Pipeline managing.Selecting technologies and equipment for Lab/Pilot Plant and Analytical Development lab.Budgeting for R&D Department.Organization Chart for R&D Department creation and Staff selection. 16 subordinates (4 direct reports).Manufacturing and Analytical Development Scheduling.New Products Committee member.QbD based Development system implementation for Argentina, El Salvador and Venezuela R&D labs.Budget follow up for Venezuela and El Salvador R&D Departments.Align R&D strategies and documentation between Argentina, El Salvador and Venezuela R&D labs. Suppliers (API, excipients, manufacturing and analytical equipment, services) selection.Direct report to CEO and Stakeholders

Buenos Aires, Argentine

Provide customers technical assistance or recommendations regarding pharmaceutical oral dosage forms formula and/or process development / manufacturing, both immediate and modified release technologies in Argentina, Uruguay and Paraguay.1 direct report.Assist customers in excipient selection.Assist customers during development, technology transfer and/or scale up processes in Colorcon or customer site.Plan manufacturing schedule in Colorcon site according customer’s needs.Commercial terms and pricing negotiation. Sales and Expenses annual budgeting.Provide technical trainings and seminars in Colorcon or customer facility.ISO supplier assessments.New excipients performance test and assessment.

Buenos Aires, Argentine

Drug Product Development from pre-formulation (Argentina) to Technology Transfer and Scale up (USA) for modified release tablets (Elementary and Push Pull osmotic pumps, hydrophilic matrices, IR/ER combinations, drug layering and multiparticulates). ANDA and NDA products.3 direct reports.Process Understanding.Scheduling daily activities in Development Lab (1 – 3 Kg capabilities). Activities follow up according to planning.CTM manufacturing responsible for BE studies.Excipients and API stock follow up.Compatibility and Stability protocols planning with Analytical Development Department.Development report for FDA filing.

Marietta, Georgia, Usa

Manufacturing scheduling and planning for Pilot Plant (10 – 60 Kg Batch size) activities for modified release technologies for ANDA and NDA products.9 subordinates (2 direct reports).Manufacturing Transfer of Technology from Argentine to USA.Technical documents for FDA filing review and approval.Annual budgeting for Pilot Plant operation.Provide technical training to Pilot Plant staff.

La Plata, Buenos Aires, Argentine

Writing and Control of filing documents for Argentina.Bibliographic research.Development solid dosage forms manufacturing.IP assistance

Buenos Aires, Argentine

Drug product and Analytical Method development for different pharmaceutical oral dosage forms.Development of MR formulations, focused on Hydrophilic Matrices, Enteric formulations and multiparticulates.Assist customers in technical troubleshooting Laboratory equipment calibration and maintenance planning.Product samples stock follow up.Provide technical trainings and seminars in Colorcon facility.Assist customers during Development scale trails in Colorcon facility.

Buenos Aires, Argentine

Study of dissolution behavior of Hydrophilic Matrix tablets.

Master In Pharmaceutical And Cosmetic Product Development

Pharmacist, Faculty Of Exact Sciences