Director Quality Assurance

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C U R R I C U L U M V I T A E

P

ERSONAL INFORMATION

Name MARIA GRAZIA MAZZONE

Address VIA MESSINA,10 95025ACI SANT’ANTONIO CATANIA Telephone 0039-3496712727 (personal mobile)

0039 3468811004 (office mobile)

E-mail [email protected] (personal)

[email protected] (work)

Nationality Italian Date of birth 2ND_J_UNE₁₉₆₁

W

ORK EXPERIENCE

Dates from January 2015 – until today

Occupation position held Name and address of employer Type of business or sector

Main activities and responsibilities

Dates from June 2012 – until January 2015

Director of Business & Portfolio Development

Reporting to the General Manager and CEO (Mr. Stefano Salvati) SIFI S.p.A, 36, Via Ercole Patti, 95025 Aci Sant’Antonio-Catania-Italy www.sifigroup.com

Pharmaceutical Industry (Ophthalmic Sterile Products and CMO for Cephalosporins capsules and syrups )

 Develop the Business and the products portolio utilizing internal and external resources and contacts in line with the Company strategy and vision

 Apply for European and domestic grants  Coordination of a team with 4 direct reports:

1. Office Management 2. Project Management 3. Scientific advisor 4. Research & Development

Occupation or position held

_{Director Quality Assurance}

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Name and address of employer SIFI S.p.A, 36, Via Ercole Patti, 95025 Aci Sant’Antonio-Catania-Italy www.sifigroup.com

Type of business or sector Pharmaceutical Industry (Ophthalmic Sterile Products and CMO for Cephalosporins capsules and syrups )

Main activities and responsibilities  Management Representative and Review of Management

 Provide feedback to CEO and Top Management on the effectiveness of the Quality Management System

 Coordination of a team of 36 people with 5 direct reports: 5. Office Management

6. Technology Transfer –Production and Analytical Transfer

7. Documentation ISO GxP Compliance-Complaints, Audits of first and second party, Deviations, CAPA, Quality Manual, Quality according to ISO 9001 and GxP (cEU GMP, GDP, GLP, GCP, GPvP), Quality Agreements for primary packaging

8. Validation & GMP Compliance (Batch record release, validation of equipments and production plants , APR/PQR, Quality Agreements for API and CMO, Process Validation Protocols and Reports. Reworking Protocols, Master batch Formula etc.)

9. Regulatory Affairs including:

 Regulatory Affairs Italy and Foreign Countries Rx and OTC drugs, Nutraceuticals, Cosmetics and Medical Devices

 Scientific Information Service (mandatory)  Pharmacovigilance (mandatory )

 Technical Regulatory (CTD Mod 3 –CMC)  Medical Affairs (CTD Mod 5-Clinical)

 Ensure compliance with the mandatory and voluntary standards, norms, and GxP

 Ensure regulatory compliance

 Maintain and improve the certification on : EU cGMP, Dlgs. 219/2006, Pharmaceutical Works/Plant Ministerial Decree, ISO 9001, ISO 13485, Product Certification for medical devices, Lig. F Deontological Codex of Italian Pharma Industries (Farmindustria) for Sales Rep and Marketing  Partecipate to the audit/inspection of first, second and third party

 Partecipate to the Regulatory Agency Inspections (EU GMP, ANVISA, ISS)  Authorize all the SOPs GxP and ISO, and documents of GMP Compliance:

validation master plan, Master batch records, Protocols and processes validations, complaints, CAPA, APR, Quality Agreements etc.  Motivate and support the people scientifically and managerially  Disseminate and support the implementation of Project , Program and

Portfolio Management, Lean six sigma

Dates from 2011 – to May 2012

Director of Product Portfolio Development & Operations

Reporting to the Business Unit Pharma Director (Mr. Antonio Benanti)

Name and address of employer SIFI S.p.A, 36, Via Ercole Patti, 95025 Aci Sant’Antonio-Catania www.sifigroup.com Type of business or sector Pharmaceutical Industry

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• Main activities and responsibilities

 Coordination of two big teams (168 people). One team dedicate to the R&D preclinical and Clinical, Regulatory Affairs with 7 direct reports. The second team dedicated to the Operations with 5 direct reports. In particular : Product Portfolio Development:

1. Project Management

2. Pharmaceutical Technology and Analytical Chemistry Unit 3. Pharmacology and Biology Unit

4. Clinical Development

5. Regulatory Affairs: Domestic and International 6. Pharmacovigilance 7. Scientific Service Operations 1. Assistant Operations 2. Supply Chain 3. Production 4. Quality Control 5. Quality Assurance/QP/Validation

 Improve the efficiency and productivity of the Operations.(30% in six months)  Improve the GMP compliance of the Operations

 Update the old CTD

 Improve the Products Portfolio Development trough the development of new products or re-formulation of old products, improve analytical methods  Supports the clinical development and the marketing needs in the scientific

relationship

 Coordinate the writing of Research Projects for public financial support with national and international partners (2 big project granted)

 Participate to the working group of the National UNI commission Quality Service and International TC236 for the standard ISO 21500 on Project Management

Dates from 2006 – to 2010

_{Head of Project Management and Industrial Planning}

Reporting to the Business Unit Pharma Director (Dr. Daniel Sher) Name and address of employer SIFI S.p.A, 36, Via Ercole Patti, 95025 Aci Sant’Antonio-Catania

www.sifigroup.com Type of business or sector Pharmaceutical Industry

• Main activities and

responsibilities

 Prepare a portfolio of new products to develop with a NPV rank, depending on the competitive scenario and Company needs.

 Coordination of 16 Project Managers in a matrix organization with related projects. The projects were at different time to market ( short<3 years; medium 3-5 years; long term> 5years) and in different ophthalmic therapeutic areas.

 Launches of new products every year starting from 2006 to 2010

 Technical referent on “Biomaterials Micro.Nanostructured” for the Sicily’s Technological District of Micro e Nano systems. Coordination of different project proposal becoming by different stakeholders (Universities, Private and Public Companies-SME and big Company, Center of National Research etc.)  Represent the Italian Country, as UNI referent, in the international

commission for the drafting of ISO21500 on Project Management  Patent filing

 Papers and poster presentations • Dates from 2004 – to 2006

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Name and address of employer

R&D Coordination Manager

Reporting to CFO (Mr Attilio Aglietta)

SIFI S.p.A, 36, Via Ercole Patti, 95025 Aci Sant’Antonio-Catania www.sifigroup.com • Type of business or sector Pharmaceutical Industry (R&D)

• Main activities and responsibilities

 Coordination of a team with about 22 people with different expertise in formulation, analytical development and preclinical development

 Coordination of projects s in preclinical (safety, efficacy, pharmacokinetics, microbiology)

 Coordination of project in Pharmaceutical Technology  Patent filing

 Papers and poster presentations Dates from 2000 – to 2006

_{Modern Drug Delivery Manager}

Reporting to the R&D Director (Prof. Vincenzo Enea)

• Name and address of employer SIFI S.p.A, 36, Via Ercole Patti, 95025 Aci Sant’Antonio-Catania www.sifigroup.com • Type of business or sector Pharmaceutical Industry (R&D)

• • Main activities and responsibilities

 Scouting of new delivery systems with University and private startup companies

 Development of new technological platforms for the delivery of hydrophilic, amphiphilic and lipophilic drugs

 Scouting of new in vitro and in vivo models for dry eye  Team member of a Programme on gel development

Dates from 1987 – to 2000 Occupation or position held • Name and address of employer

Pharmaceutical Technology &Analytical Chemistry Manager

Reporting to the Scientific Director (Dr. Mangiafico_Dr. Ceccarini-Prof.Enea) SIFI S.p.A, 36, Via Ercole Patti, 95020 Lavinaio

• Type of business or sector Pharmaceutical Industry (R&D) •

• Main activities and responsibilities

 Planning and performing formulation and preformulation study on new and adopted chemical entities

 Developing and validating analytical methods

 Planning and performing stability studies and elaborating data

 Developing new methods to study chemical physical properties of new formulation and characterization

 Project manager of Lacrimal substitutes and Dry Eye

 Team member of International Team to develop antiglaucomatous drugs (Bausch &Lomb, Santen, Chauvin, Leiras,, Cusì, IOMED J&J)

 Development of two platforms of drug delivery gel and emulsion

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• Dates (from 1981 – to 1987) Master degree in chemistry (course of specialization: organic chemistry and biorganics) • Name and type of organization

providing education and training

Department of Chemistry, Faculty of Natural Science, Maths and Physics, University of Catania

• Principal subjects/occupational skills covered

Organic and Inorganic chemistry, analytical chemistry, Bio-organic and Bio-inorganic chemistry,

Science of material, Physical Chemistry and studies on the chemical surfaces • Title of qualification awarded

• Level in national classification Professional exam (1987)

Degree Chemistry 110/110 cum laude,

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S

PECIALIZATION COURSES AND

P

ROFESSIONAL COMPETENCES

M

ANAGEMENT COURSES

AND COMPETENCES

1988 Structure and Proprieties of polymers in the technological application of controlled release. Prof. N.A. Peppas Pardue University, West Lafayette USA.

1989 L’analisi termica nella preformulazione farmaceutica Scuola di Specializzazione in Farmacia Industriale, Università degli Studi di Pavia.

1990 Recenti acquisizioni nel rilascio, direzionamento e somministrazione di farmaci X Corso Avanzato di Chimica Farmaceutica Università degli Studi di Padova.

1991 Drug Delivery & Targeting Systems Prospects for the 90’s” Organised by IBC London.

1993 Methods to overcome biological barriers in drug delivery University of Kuopio Finland.

1995 Emulsion-Suspension Technology Dr. Stanley L. Hem, Dr. Norman D. Weiner Center for Professional Advancement Amsterdam.

1999 Maximising Value & Extending Product Life Through Effective Drug Delivery Systems IIR Limited London.

1999 Workshop on Mass Spectrometry of Polymers Institute for Chemistry and Technology of Polymeric Materials-Catania.

2000 Pharmacokinetic-pharmacodynamic modeling: an introductory course, held in conjunction with Millennial World Congress of Pharmaceutical Sciences, San Francisco-California. Organizers: W.J.Jusco Ph.D Prof. Of Pharmaceutics. School of Pharmacy of the State University of New York at Buffalo, Meindert Danhof Ph.D.Professor of Pharmacology Leiden/Amsterdam, Center for Drug Research. 2000 Controlled Release : into the 21st_{Century, held in conjunction with Millennial} World Congress of Pharmaceutical Sciences, San Francisco California. Organizer CRS: R.A. Siegel, ScD University of Minnesota.

2000 Ocular Genomics and Proteomics. Alcon Laboratories, Inc. Fort Worth Texas. 2001 Intracellular Drug Delivery Worshop CRS San Diego California.

2005 Preparazione di campioni per la sperimentazione clinica (IMPs) e clinical trials: direttive e applicazioni pratiche. Pharma Education Center. Pharma D&S Pomezia. Italy.

2006 Gli Innovation Relay Center network. L’esperienza italiana nella rete europea per l’innovazione e il trasferimento tecnologico transnazionale.

2012 Good Manufacturing Practice IIR –Dr.ssa Nipoti, SIFI 2012 Product Quality Review IIR Dr.ssa Nipoti, SIFI 2012 Batch records IIR-Dr.ssa Nipoti, SIFI

2012 Sicurezza sul lavoro dlgs. 81/2008 e m.s.

2012-2013 Sistemi di qualità ISO9001 e GMP. Biochem srl, SIFI

1996 Rompere le Barriere Organizzative: Modelli Mentali e Dialogo. AKRON Centro

per lo Sviluppo e l’Innovazione Manageriale.

1996Leadership:gestione e futuro dei collaboratori AKRON Centro per lo Sviluppo e l’Innovazione Manageriale

1999 Team working.George Kohlrieser Ph.D., SIFI.

1999 Negotiation Skills.George Kohlrieser Ph.D., SIFI.

2001Fondamenti di Analisi Economica-Finanziaria Prof. Cacciamani docente Università L. Bocconi e consulente AKRON.

2004 Creare valore d’impresa per la crescita e lo sviluppo: costruiamo e sviluppiamo i

nostri intangible asset Prof. Giuseppe Toscano Università Cattaneo-LIUC Castellanza.

2007 Project Management Advanced.AMF&Partners, Registered Education Provider

PMI (Project Management Institute).

2009 Project, Programme and portfolio Management . Pete Harpum; Harpum consulting UK, SIFI

2013 Stakeholder Management PMI Rome Chapter, SIFI

M

OTHER TONGUE Italian

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English • Reading skills good

• Writing skills good • Verbal skills good