Federica Toncelli has over 20 years of experience in vaccine production and quality control. She is currently the Head of Bacterial glyconjugate vaccine manufacturing at GSK in Italy, where she manages a team of over 240 employees and is responsible for vaccine manufacturing processes, quality standards, safety, and financial management. Previously, she held various leadership roles in vaccine production and quality assurance at Novartis and Chiron. Toncelli has a degree in Biological Science from the University of Pisa and specialized training in areas such as cell culture, protein purification, and experimental surgery.

1. Europass
Curriculum Vitae
Personal information
First name(s) / Surname(s) TONCELLI FEDERICA
Address(es) Via S. Antonio Ulivelli,53, 53034 Colle di val d’Elsa (SI)- Italy
Telephone(s) +39 3287608195
E-mail federica.x.toncelli@GSK.com
Nationality Italian
Date of birth 24 August 1968
Gender female
Work experience More than 20 years of experience in vaccine production and control.
Dates - From October 2012 up to 2016 Head of Bacterial glyconjugate vaccine manufacturing at GSK
(formerly Novartis)
- From May 2011 up to September 2012; Head of Quality Operation for the Bacterial segment at
Novartis
- From July 2009 up to April 2011 Technical lead of a technology transfer project from two Novartis
sites
- From Q4 2006 up to June 2009: Head of viral vaccine manufacturing at Novartis (formerly
Chiron)
- From 2003 up to 2006: Production Manager at Chiron, responsible of all the activities related to
the Influenza vaccine manufacturing
- From 1998 up to 2002 : Production Deputy Manager at Chiron , co-responsible of all the
activities related to the Influenza vaccine manufacturing.
- From 1995 up to 1998: Production Supervisor at Chiron
Occupation or position held Head of Bacterial glyconjugate vaccine manufacturing at GSK Italy
Main activities and responsibilities - Manage manufacturing processes to ensure products are delivered on time and on budget while
maintaining high quality standards
- Guarantee the building safety and ensure compliance with all regulations
- Supervise and guide a team of managers and operators, over 240 employees. Assure their
organization, training/education and people development
- Utilize Lean Manufacturing strategies to improve manufacturing processes and minimize
unnecessary costs and maintain the current quality standards
- Financial management of several cost centers
Name and address of employer GSK
Type of business or sector Vaccine
Education and training
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2. Dates High education qualifications
- Admission to Italian Biological Association (“Ordine Italiano Biologi”)1993:
University of Pisa- Italy,ID number 042790.
- Post degree training for Admission to Italian Biological Association,1992-93
University of Pisa- Italy, Facoltà di Scienze Biologiche, Department of Zoology,Training in cell culture,
protein purification and spectrophotometric measurements
- Training in experimental surgery on animal model, animal care, preparation and reading of
histological samples, 1993
University of Florence-Italy, Unit of Plastic Surgery
- University degree, 04th
November 1992: University of Pisa- Italy, Facoltà di Scienze Biologiche
First-class Honors Degree in Biological Science, Experimental thesis in Biophysics
Title of qualification awarded University degree in biological science
Principal subjects/occupational skills
covered
Vaccine manufacturing, technology transfer, quality assurance and quality control
Name and type of organisation
providing education and training
University of Pisa, University of Florence
Personal skills and
competences
Mother tongue(s) Italian
Other language(s) English, fluent
Organisational skills and
competences
- Human resource: team organization/building , managing of international teams, coaching and
mentoring collaborators . Proven organizational ability to build successful teams
-
Technical skills and competences - Extensive expertise in Vaccine production technologies (viral and bacterial vaccines)
- Expertise in Lean manufacturing with extensive scope of responsibility and a proven track record
of delivering optimal results in a growing environment that exceeds operational goals.
- Quality system for bio-pharmaceuticals: international guidelines for sterile product, documentation
management , requirements and validations for building and equipment to be used in vaccine
manufacturing.
- Competences and deep knowledge of the Influenza field : virology, epidemiology,
- Quality Assurance: broad expertise in overseeing of the following processes: Deviations, Batch
Record Review, CAPA implementation, Change Control, Documentation and Validation.
- Quality control laboratories: expertise in chemistry analytical testing technologies.
- Project coordination : Technology transfer between manufacturing sites, how to organize and
manage a technology transfer of drug substances
- Training and education: solid expertise in delivering education programs for manufacturing
employees
- Regulatory affairs: expertise in supporting Regulatory as SME to deliver Agency Meeting
packages, to held Scientific Advice Meetings. Expert report writing for annual regulatory variations
in Eu
- Development Technology: expertise in supporting the Department as SME for the execution
development/ technical Studies
- SAP: SAP implementation Project , core team member (Production planning- Production Control
team)September 1998 – April 1999: Chiron. - Emeryville, CA- U.S.A.:
Computer skills and competences Extensive knowledge of Office packages (Word, Excel, Power point,) ,SAP, Sentry DR/CAPA, Atlas,
Labware LIMS, Share Point, WEB Training,
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3. Additional information Professional Qualification
- 2005: ottobre- Malta: attendance to “The second European Influenza Conference
- 2004: May-Lisbon attendance to “influenza vaccine for the world”
- 2004:- April- Edinburgh attendance to 3rd Annual Biological Forum
- 2003: October- Okinawa (Japan): attendance to “Options for the control of Influenza V”.
- 2002: ottobre- Malta: attendance to “The first European Influenza Conference”
- 2002: May - Bergen (Norway): attendance to the workshop “Laboratory Correlates of Immunity to
Influenza”.
- December 2001- March 2002- Siena, Italy, attendance to the Training “L’arte del Management: il
valore di un esempio esemplare”
- ( Studio del Feo for Chiron S.p.a.)
- 2001: 13-15 June –Amsterdam :(“The center for Professional Advancement”): attendance to
“ritical process cleaning and cleaning validation” course .
- 2001, 6 June - Napoli: attendance to the seminary :”I vaccini per la tutela della salute
dell’anziano”
- 2001: March - Chiron S.p.a: attendance to the seminary “Management GMP training”
- 2000: 20-22 November – Chiron S.p.A- attendance to the course “Validation by Design”
- 2000: 13-15 November – Milano European Consulting School Milano: attendance to the course
“Formazione giovani Managers
- 2000: 23-28 July -Hersonisson Creta: attendance to the the congress “Options for the control of
Influenza IV”.
- 2000 :17-21 July – Paris, Institut Pasteur, : attendance to the course: “ESWI Lab course: basic
laboratory methods for influenza diagnosis
- 2000 : July, Siena: attendance to the course: “Principi ed organizzazione del sistema contabile
Integrato Aziendale.
- 2000: 19-21 June , Rome: attendance to the course “advanced training course – il mercato
biofarmaceutico, usi ed applicazioni delle tecnologie di separazione “
- September 1998 – April 1999: Chiron. - Emeryville, CA- U.S.A.: SAP Project , core team member
(Production planning- Production Control team)
- 1998: March , Amsterdam: (“The center for Professional Advancement “)attendance to the
course Intensive Course cGMP and Quality Issues for Biopharmaceuticals”.
- 1997: June, Genova: attendance to the seminary “Influenza e vaccini”
- 1996: December , Siena: attendance to the course “ Batch Record Review and Investigation”.
- 1996: December , Amsterdam, (“The center for Professional Advancement”), attendance to the
Intensive Course “U.S. FDA Regulatory Compliance”.
- 1996 , August , Jerusalem; attendance to the Xth International Congress of Virology.
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4. BIBLIOGRAPHY
- Laser-assisted microvascular anastomosis without suture stays: experimental
demonstration in femoral vessels of rats
- R. Gelli, R. Pini, F. Toncelli, C. Chiarugi, U. M. Reali.
- Submitted to Plastic and Reconstructive Surgery (Nov. 94)
- Diode laser-assisted microvascular anastomosis: clinical and histological results on long
period follow up.
- U.M. Reali, R. Gelli, V. Giannotti, F. Gori, R. Pini, F. Toncelli, U. Vanni.
- Proceed of Biomedical Optics 94, SPIE VOL 2128, paper 2128-72, Los Angeles (1994)
- Clinical and histological results of diode laser- assisted experimental microvascular
anastomosis.
- U.M. Reali, R. Gelli, V. Giannotti, R. Pini, F. Toncelli, C. Chiarugi, L. Borgognoni
- International Symposium on Plastic Surgery, Florence, May 21-24, 1994.
- Diode laser welding in microvascular applications
- U.M. Reali, R. Gelli, V. Giannotti, M. D’Anna, R. Pini, F. Toncelli, U.Vanni.
- Proceedings of Biomedical Optics Europe 94, SPIE Vol. 2327, paper 2327-18, Lille
(1994).
- Preliminary experience on diode laser welding of skin
- U. M. Reali, L. Borgognoni, L. Martini, C. Chiarugi, F. Gori, R. Pini, F. Toncelli, U. Vanni
- Proceedings of Biomedical Optics Europe 94, SPIE Vol. 2327, paper 2327-21, Lille
(1994)
- The development of a “closed system” for the purification of influenza virus for vaccine
production by adsorption to barium sulphate.
- A.E. Colegate, F. Toncelli, V. Pellegrini.
- Proceedings of Xth International Congress of Virology, pag. 190.
- Fotomovimento e fotosensibilizzazione mediati da blefarismina in Blepharisma
Japonicum
- F.Ghetti, D. Gioffrè, G. Checcucci, G. Damato, C. Paradiso, F. Toncelli, F. Lenci.
- Convegno Annuale della Società Italiana di Fotobiologia, Capri Giugno 1991.
- Il laser a diodo in chirurgia microvascolare: nostra esperienza.
- R. Gelli, V. Giannotti, M. D’Anna, R. Pini, F. Toncelli, U: Vanni, U.M. Reali.
- Atti dell’11° Congresso Nazionale della Società di Laser Chirurgia e Medicina:
“L’optoelettronica Laser in Terapia e Diagnosi Medico/ Chirurgiche”, Firenze (21-23 Ott.
1993)
- Saldatura di tessuti con laser a diodo: esperienze in chirurgia microvascolare.
- U.M. Reali, R. Gelli, V. Giannotti, C: Chiarugi, L. Martini, L. Borgognoni, M. D’Anna, R.
Pratesi, R: Pini, F. Toncelli, U. Vanni
- Atti del XVIII congresso del settore FAM del GNSM-CNR e IV Congresso della sezione A
dell’INFM, poster B-15, Firenze 26-29 ottobre 1994.
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© European Union, 2004-2010 24082010