Experience

Adare Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Senior Industrialization and Technology Transfer Manager

  • Jan 2023 - Present

  Milano, Lombardia, Italia - Head of the industrialization team for the Italian sites (Pessano con Bornago and San Giuliano) - Commercial Technology Transfer (TT) Project Manager and assignment of Commercial TT projects to the other members of the Team. Preparation of commercial proposals - Point of reference for the Global Business Development Team, providing all the information needed to prepare the commercial proposals - Assessment of technical feasibility, preparation and assessment of COGs (cost of goods),… Show more - Head of the industrialization team for the Italian sites (Pessano con Bornago and San Giuliano) - Commercial Technology Transfer (TT) Project Manager and assignment of Commercial TT projects to the other members of the Team. Preparation of commercial proposals - Point of reference for the Global Business Development Team, providing all the information needed to prepare the commercial proposals - Assessment of technical feasibility, preparation and assessment of COGs (cost of goods), capital investments and capacity analyses of commercial products - Coordinates Technology Transfer to Third Parties (outsourced operations) - Collaboration with R&D to scale-up and validate new products from lab to industrial scale, responsibility for industrial scale registration batches - Responsibility for Life Cycle Management of existing commercial products, including recurrent manufacturing process validation activities, process improvement and optimization - Process Validation: responsibility for Manufacturing Process Validation Plan, writing and management of report and protocol, collaboration with Manufacturing and Quality - Improvements and troubleshooting: identification of quality improvement and cost reduction opportunities - Project management and technical support and to add new sources of API, excipients, and packaging components. Show less



FAREVA

• Manufacturing
• 700 & Above Employee

• R&D Manager

  • Feb 2020 - Jan 2023

  Bergamo, Lombardy, Italy CDMO for pharmaceutical products, food supplements, cosmetics and medical devices - Head of R&D Department - Project Management for Pharmaceutical Products, Food Supplements and Medical Devices - Pharmaceutical Development - Development of Food Supplements and Medical Devices - Oversight of scale-up and industrialization processes - Oversight of Technology Transfers - Process Validation - Technical documentation: Dossier Pharmaceutical Development (3.2.P.2) and… Show more CDMO for pharmaceutical products, food supplements, cosmetics and medical devices - Head of R&D Department - Project Management for Pharmaceutical Products, Food Supplements and Medical Devices - Pharmaceutical Development - Development of Food Supplements and Medical Devices - Oversight of scale-up and industrialization processes - Oversight of Technology Transfers - Process Validation - Technical documentation: Dossier Pharmaceutical Development (3.2.P.2) and Manufacturign (3.2.P.3), Common Technical Document (CTD), Galenical Development, Technology Transfer Package, Technical Dossier, Risk Assessment/FMEA - Management of the R&D Team - Management of the R&D Department: budget, Capex, Opex - Collaboration and support to Business Development and Key Account Manager - Report directly to VP R&D Fareva and site General Manager - Collaboration with other Fareva sites for different projects and activities Show less



APR Applied Pharma Research s.a.

• Switzerland
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Technical Development Manager

  • Feb 2017 - Feb 2020

  Balerna, Canton Ticino, Svizzera - Project and product management - Development of pharmaceutical oral dosage forms (tablets, granules, powders, solutions) - Development of pharmaceutical nutraceutical oral dosage forms (tablets, granules, powders) - Support and collaboration with CMOs during scale-up and indutrialization of products - Writing and management of scientific and technical reports: CTD module 3.2.P.2 Pharmaceutical development, Technical Dossiers, Technology Transfer Package, Galenic Development… Show more - Project and product management - Development of pharmaceutical oral dosage forms (tablets, granules, powders, solutions) - Development of pharmaceutical nutraceutical oral dosage forms (tablets, granules, powders) - Support and collaboration with CMOs during scale-up and indutrialization of products - Writing and management of scientific and technical reports: CTD module 3.2.P.2 Pharmaceutical development, Technical Dossiers, Technology Transfer Package, Galenic Development Reports - Presentation and communication of project status and results at internal meeting and customers - Collaboration and communication with internal and external departments (Manufacturing, Contract Manufacturing Organizations, Quality Control, Preclinical, Clinical, Regulatory, Marketing)

• Technical Development Specialist

  • Nov 2015 - Feb 2017

  - Preformulation and formulation of NCEs and known API - Development of pharmaceutical and nutraceutical solid oral dosage forms (tablets, granules, powders) - Support and collaboration with CMOs during scale-up and industrialization - Quality control for solid and liquid oral dosage forms - Stability testing of drug substances and pharmaceutical products (ICH guidelines) - Writing and management of scientific and technical reports - Collaboration and communication… Show more - Preformulation and formulation of NCEs and known API - Development of pharmaceutical and nutraceutical solid oral dosage forms (tablets, granules, powders) - Support and collaboration with CMOs during scale-up and industrialization - Quality control for solid and liquid oral dosage forms - Stability testing of drug substances and pharmaceutical products (ICH guidelines) - Writing and management of scientific and technical reports - Collaboration and communication with Quality Control, Manufacturing and CMOs



Università di Pavia

• Italy
• Higher Education
• 700 & Above Employee

• Ph.D. student in Chemistry and Pharmaceutical Technology

  • Nov 2012 - Feb 2016

  Address: Pharmaceutical Technology. Research project: “Pharmaceutical technologies for drug targeting in the gastrointestinal tract to improve active pharmaceutical ingredients bioavailability” - Preformulation and formulation of APIs and pharmaceutical solid oral dosage form - Development of immediate release oral dosage forms - Development of modified release oral dosage forms - Colon delivery systems - Gastro-resistant systems - Gastro-retentive… Show more Address: Pharmaceutical Technology. Research project: “Pharmaceutical technologies for drug targeting in the gastrointestinal tract to improve active pharmaceutical ingredients bioavailability” - Preformulation and formulation of APIs and pharmaceutical solid oral dosage form - Development of immediate release oral dosage forms - Development of modified release oral dosage forms - Colon delivery systems - Gastro-resistant systems - Gastro-retentive systems - Solubility and dissolution rate enhancement of poorly soluble drugs (BCS class II and IV) - Quality control for solid oral dosage form - Stability testing of drug substances and pharmaceutical products (ICH conditions) - Writing and management of scientific publications Show less



Farmacia Esposti

• Trainee

  • Nov 2010 - Dec 2011

  Torrazza Coste (Pv) Traineeship at Farmacia Esposti. Main activities and responsibilities: knowledge about pharmaceutical, homeopatic and cosmetic products. Medicinal dispensation, prescriptions and registers management, counter sales.