Available to hire
I am a senior pharmaceutical and biotech consultant with more than 40 years of experience in engineering, technology transfer, process development, CAPEX delivery, commissioning, qualification and validation. My work has focused on sterile manufacturing, aseptic filling, barrier isolators, containment, high-potency APIs, micronization, nanotechnology and GMP-compliant production environments. I have supported global pharmaceutical companies, CDMOs and biotech organizations with greenfield and brownfield projects, remediation plans, inspection readiness, quality systems and operational improvements.
Experience Level
Expert
Expert
Expert
Expert
Expert
Expert
Expert
Expert
Language
Italian
Fluent
French
Fluent
English
Fluent
German
Intermediate
Spanish; Castilian
Intermediate
Work Experience
Senior Consultant at FPS
January 1, 2026 - PresentSupported updates to fill-finish processes using barrier isolators, RABS and aseptic filling lines. Managed Annex 1 and contamination control strategy activities, including project planning, design, installation, commissioning and qualification.
Senior Consultant at Datwyler
January 1, 2026 - PresentPrepared remediation plans involving CAPEX, inspection readiness, technology transfer, engineering and packaging support.
Senior Consultant at Adare Pharma Systems
January 1, 2026 - PresentSupported new CAPEX for integration of multipurpose HPAPI manufacturing with OEB4-6 containment. Supported design qualification for MAL and BIBO systems within Annex 1 requirements.
Consultant at PTM Consulting
January 1, 2025 - PresentSupported commissioning of aseptic barriers for fill-finish processes involving vials, syringes and cartridges, as well as containment solutions.
Senior Consultant at Microsphere
January 1, 2025 - PresentLed end-to-end CAPEX activities for a new production building, engineering, manufacturing startup and commissioning of glovebox isolators. Managed technology transfer from clinical trials to pilot plant, supplier battery limits and Swissmedic and FDA inspection readiness.
Consultant at Adare Pharma Solutions
January 1, 2025 - PresentDeveloped containment design solutions and supported inspection readiness and engineering CAPEX planning for a new HPAPI department.
Interim Engineering and Utilities Manager at Leo Pharma
January 1, 2025 - PresentWorked in a matrix organization supporting brownfield modernization CAPEX, remediation planning and quality assurance inspection readiness for engineering and utilities activities.
Consultant at PTM Consulting
January 1, 2025 - PresentProvided technology transfer, process design, engineering, barrier isolation and containment support. Managed process qualification and validation, remediation planning, inspection readiness and regulatory assessment for process implementation.
Consultant at Adare Pharma Solutions-Italy-USA
January 1, 2025 - November 27, 2025Focused on containment design solutions and engineering support for inspection readiness.
Consultant, Engineering/Utilities Manager Interim at Leo Pharma-Italy-IRL
January 1, 2025 - November 27, 2025Supported QA for inspection readiness and developed remediation plans in a matrix organization.
Consultant at PTM Consulting-Italy
January 1, 2025 - November 27, 2025Provided expertise in process design, engineering, barrier isolation, and containment, focusing on remediation plans and inspection readiness.
Aseptic Techniques Coach and Consultant at Zambon
January 1, 2024 - PresentCoached aseptic techniques and supported QA, engineering and production with remediation, regulatory assessment, capital projects, schedules, documentation, qualification and validation. Supported sterile production-line modernization, CAPEX execution and Swissmedic and FDA inspection readiness.
Global Support Consultant at Medicom
January 1, 2024 - PresentProvided global support for remediation plans, quality and operations in biotech and pharmaceutical environments, and technology transfer activities for contract manufacturing organizations.
Coach at Zambon-Switzerland
January 1, 2024 - November 27, 2025Coached in aseptic techniques while supporting QA, Engineering, and Production for CAPEX and remediation.
Global Consultant at Medicom-Canada
January 1, 2024 - November 27, 2025Provided global support for remediation plans, focusing on quality and operations in biotech and pharma.
Consultant at Medicom
January 1, 2023 - PresentSupported remediation plans, pre-approval inspection activities, inspection readiness, technology transfer and cGxP compliance.
Consultant at Zambon
January 1, 2023 - PresentDeveloped remediation plans for contamination control strategy and Annex 1 compliance. Supported inspection readiness across QA, QC, MSAT, engineering and operations, as well as CQV, CAPEX, risk management and project risk mitigation.
Senior Consultant at Polypeptide
January 1, 2023 - PresentSupported inspection readiness, coaching, product quality review, investigations, deviations, change controls and CAPA planning. Assisted QA with documentation, batch record review, biotech engineering processes, maintenance planning, cost monitoring and cGxP compliance.
Senior Consultant at Görgens Engineering
January 1, 2023 - PresentSupported technology transfer and all commissioning, qualification and validation phases, including engineering qualification and validation activities.
Consultant at Thermo Fisher Scientific Patheon
January 1, 2022 - PresentSupported remediation, sterility assurance, aseptic technique training, Gemba activities, GMP and GDP compliance across eight manufacturing lines. Supported startup and commissioning of isolator filling lines, inspection readiness, gap analysis, risk management and CAPEX modernization for vials, syringes and cartridges.
Senior Consultant and Sterility Assurance Interim Manager at Sanofi
January 1, 2022 - PresentLed sterility assurance activities for flexible prefilled syringe lines, barrier isolator integration, commissioning, fill-finish and packaging processes. Supported Annex 1 upgrades, FDA and GMP/GDP inspection readiness, quality risk management, CQV, CDMO battery limits and greenfield CAPEX for a new production building.
Consultant at Medicom
January 1, 2021 - PresentSupported the Swiss vaccine production task force, production organization and distribution, fill-finish operations, barrier isolation technologies, medical devices and sanitation techniques involving photocatalytic reactor technology.
Consultant and Technology Transfer SME at CureVac
January 1, 2021 - PresentSupported technology and process transfer to contract manufacturers for mRNA vaccine production. Managed GMP, GLP and GDP documentation transfer from development to commercial operations, identified technical gaps, oversaw PPQ activities and supported CMOs using flexible syringe and vial lines.
Advisor at Bruschettini
January 1, 2020 - PresentSupported FDA and AIFA inspection readiness, pre-approval inspection activities, remediation plans, gap analysis, technology transfer and engineering revamps of aseptic fill-finish lines using RABS and barrier isolation. Managed quality documentation, process validation, smoke studies, media fills, utilities qualification and GMP compliance.
Consultant and Capital Projects Manager at Teva-Sicor
January 1, 2020 - PresentManaged end-to-end CAPEX projects for hormones, steroids, APIs and HPAPIs from synthesis to final micronization in glovebox isolators. Coordinated MS&T, engineering, QA and production, managed supplier battery limits and led strategic projects for a new HPAPI production area.
Consultant and Engineering SME Coach at Teva-Sicor
January 1, 2019 - PresentSupported engineering, QA and production with CAPA, CAPEX and remediation plans for steroid and hormone production lines. Led AIFA inspection readiness, maintenance planning, risk assessment, barrier isolator integration, regulatory assessment and project risk evaluation.
Consultant and SME at Teva-Actavis
January 1, 2018 - PresentSupported remediation, inspection readiness, gap analysis and GMP/GDP compliance for FDA and AIFA. Coached engineering on fill-finish line modernization, quality documentation, validation batches, PQRs, change controls, deviations, preventive maintenance and containment strategies for cytotoxic and high-potency compounds.
Project Manager at Microsphere
January 1, 2017 - PresentManaged end-to-end greenfield CAPEX for a new production building, including engineering, manufacturing, startup and commissioning of glovebox isolators for fluid bed and spray dryers, micronizers and nanotechnology equipment. Led technology transfer, qualification, FAT/SAT, process validation, business planning, budget control, risk mitigation and inspection readiness.
Consultant at Janssen
January 1, 2016 - PresentSupported inspection readiness, remediation and engineering modernization of aseptic RABS lines. Provided QA documentation, validation batches, commissioning, PQR, installation and validation support across R&D, MS&T, API, sterile, HPAPI and biotech operations.
Coach and Project Manager at Micro-Sphere
January 1, 2015 - PresentManaged commissioning, installation and validation of NANONIZER equipment integrated into an active glovebox isolator for API and sterile R&D. Supported inspection readiness, CAPA, remediation, cleanroom organization, equipment purchasing, process development, qualification, validation, stability, comparability, robustness and fill-finish activities.
Project Manager at FPS
January 1, 2014 - PresentManaged fill-finish process upgrades involving barrier isolation, RABS, sterility testing, aseptic filling, sterile jet milling, dryers, vessel charging, dispensing and VHP decontamination. Managed project planning, design, installation, commissioning, qualification and budget availability across all CQV phases.
Inventor and Technology Developer at Independent
January 1, 2013 - PresentDesigned and patented the NANONIZER Fluid Energy Mill prototype for nanotechnology applications. Completed the business plan, project evaluation and lifecycle risk mitigation.
Engineering, Design and R&D Specialist at Hosokawa Alpine
January 1, 2012 - PresentDesigned and developed fluid jet mills and feeding processes. Transferred scale-up knowledge from laboratory and R&D systems to production environments.
Technology Transfer Consultant at Görgens Engineering
January 1, 2012 - PresentSupported technology transfer for dry powder feeding, milling, micronization and nanonization technologies, including all commissioning, qualification and validation phases.
Technology and CQV Consultant at FPS
January 1, 2011 - PresentSupported powder transfer, feeding, milling, micronization, containment, barrier isolation, sterile and aseptic environments, and qualification and validation of related technologies.
Engineering and R&D Consultant at Ayla Engineering
January 1, 2010 - PresentDesigned the IPVG in-process variable geometry fluid energy mill and initiated development of the NANONIZER jet mill for small-scale nanoparticle particle-size distribution applications.
Engineering and R&D Specialist at Hosokawa Alpine
January 1, 2008 - PresentDeveloped and designed the Piconizer laboratory and R&D jet mill generation in Japan and Germany.
Consultant and Coach at Merck MSD
January 1, 2007 - PresentProvided consulting and coaching on micronization, containment and barrier isolation processes. Supported project scheduling for synthesis and steroid manufacturing through contract manufacturing organizations.
Engineering and Technology Consultant at Ayla Engineering
January 1, 2005 - PresentDesigned barrier isolators, sterile fill-finish, mixing, milling and micronization technologies for cytotoxic and sterile applications. Managed process validation in GMP and FDA contract facilities and technology transfer.
Founder and Consultant at AYLA Consulting
January 1, 2001 - PresentFounded the consulting company and provided consulting services for JP-Munit, with a focus on pharmaceutical process engineering and technology.
Global R&D and Technical Director at Jetpharma-Munit
January 1, 1996 - PresentLed global R&D, technical direction, technology transfer and scale-up strategies for API and HPAPI powder feeding, milling, micronization, containment, barrier isolation and sterilization. Managed CQV, project management, investments, quality audits, inspection readiness, facility commissioning and international site operations.
Process and Technology Transfer Manager at APTM
January 1, 1988 - PresentCommissioned mixers, milling and micronization units, spray and fluid bed dryers, freeze dryers, autoclaves and barrier isolators. Managed GMP production documentation, process development, technology transfer, automation controls, stability and comparability studies, process robustness and troubleshooting. Project-managed the first worldwide jet mill system integrated into an active barrier isolator and the first closed-loop nitrogen micronization unit.
Project Manager at MicroMacinazione/Lonza
January 1, 1985 - PresentUpgraded jet mills and manufacturing equipment, managed external CMOs and suppliers, and followed equipment qualification and validation for a GMP contract micronization facility approved by the FDA. Patented new fluid jet mill solutions.
Project Engineer at Tecnodelta Engineering
January 1, 1984 - PresentDesigned equipment for racing engines.
Education
B.Sc. at HES Engineering, Bienne
January 1, 1981 - January 1, 1984STS High Technical School at Lugano
January 1, 1979 - January 1, 1981Primary and secondary Gymnasium at Lugano
January 1, 1968 - January 1, 1978Bachelor of Science in Engineering at HES Engineering, Bienne
January 1, 1981 - January 1, 1984Higher Technical School Diploma at STS High Technical School, Lugano
January 1, 1979 - January 1, 1981Primary and Secondary Gymnasium Education at Gymnasium School, Lugano
January 1, 1968 - January 1, 1978Qualifications
International PCT Patent for NANONIZER
January 1, 2017 - September 19, 2026National Patent for NANONIZER
January 1, 2016 - September 19, 2026Trademark of NANONIZER
January 1, 2012 - September 19, 2026European Outsourcing Award: Most Effective Scale-Up/Tech Transfer Award
January 1, 2006 - September 19, 2026Swiss Technology Award for MCONE Fluid Jet Mill and NanoFeeder
January 1, 2003 - September 19, 2026Best in Show Award, Chicago Powder Bulk Exhibition
January 1, 2003 - September 19, 2026Trademark for NanoFeeder
January 1, 2001 - September 19, 2026Trademark for MCONE Miniaturized Jet Mill
January 1, 2000 - September 19, 2026Trademark for Pharmastar RotoValve
January 1, 1999 - September 19, 2026Glaxo Award of the Year for Fluid Jet Mills Integrated in Automated Active Isolators
January 1, 1989 - September 19, 2026Patent for Fluid Jet Mill Innovation
January 1, 1987 - September 19, 2026Dissolution, Bioequivalence and Bioavailability Certificate of Attendance
January 1, 2005 - September 19, 2026Containment of Potent Compounds Certificate of Attendance
January 1, 2004 - September 19, 2026Containment of Potent Compounds Certificate of Attendance
January 1, 2003 - September 19, 2026Containment of Potent Compounds Certificate of Attendance
January 1, 2002 - September 19, 2026Management Certificate of Attendance
January 1, 2001 - September 19, 2026Gravimetric Feeders System Training
January 1, 2001 - September 19, 2026Barrier Isolation Technology Certificate of Attendance
January 1, 2001 - September 19, 2026Containment of Potent Compounds Certificate of Attendance
January 1, 2001 - September 19, 2026Powders: Their Properties and Processing Certificate of Attendance
January 1, 2000 - September 19, 2026Preparing and Conducting IQ/OQ and PQ Certificate of Attendance
January 1, 1999 - September 19, 2026Industry Experience
Healthcare, Life Sciences, Manufacturing, Professional Services, Computers & Electronics, Education
Experience Level
Expert
Expert
Expert
Expert
Expert
Expert
Expert
Expert
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