Barbara Sambuco

Name: Barbara Sambuco

E-mail: sambuco.barbara@gmail.com

Studies

•             University degree in Chemistry with first class honours

             Rome, University La Sapienza 

•             Master in Biotechnology promoted by Minister of University and Scientific and Technologic Research 

Rome, University La Sapienza, CNR Montelibretti

Polybios Trieste

National Institute of Health (NHI) Bethesda Maryland US

•             Master Coaching basics level 1, Master Coaching advanced level 2  ICF certified

Job Career

2021                   Catalent. Vice President Operation BU Biologics EU

2020                   Catalent. Site General Manager

2014                   Bristol Myers Squibb. Site General Manager

2013                   Bristol Myers Squibb. Operation Director

2012                   Bristol Myers Squibb. Sterile Business Unit Director

2009                   Bristol Myers Squibb. Quality Operation Director & QP

2008                   Bristol Myers Squibb. Pharmaceutical Technology EMEA & Asia Pacific

2005                   Bristol Myers Squibb. Manufacturing Technology Senior Manager

2003                   CTP Tecnologie di Processo – Pharmaceutical Consultant 

2000                   Chiesi Farmaceutici – Manufacturing Technology Manager

1997                   Chiesi Farmaceutici - Project Leader

1994    Lepetit, Hoechst Marion Roussel - Process Development Chemist

Since 2005 Member of the Italian chapter of the PDA (Parenteral Drug Association)

Since October 2022 member of the Board of  the Rome-Technopolo

Teaching professor since 2023 at University of Torvergata in Rome 

Skills

Fluent English, Intermediate French (Delf A2), Intermediate Spanish (Dele A2)

Catalent (Sept 2021)

Vice President Operation BU Biologics EU with the responsibility of 1600 human resources.

Responsible for the growth and development of the three Bio sites in EU (France-Belgium-Italy) . Direct report of the three site GMs and the Supply Chain Director to guarantee the customer service level and the site performance indicators defined by the Biopharma Strategy. 

In addition, the role has the responsibility of the relation with the Italian government, Industrial associations, Universities to guarantee the projects fundings and to collaborate in mapping and modelling the recruiting process for the SMEs.

Direct Report to the Senior Vice President of the Biological Operations

Catalent (from Jan2020-Sept 2021)

Site General Manager with the responsibility of 890 human resources.

Responsible for the growth and development of Anagni Plant ensuring excellence of the core capabilities as defined by the Biopharma Strategy.  Leading the plant strategy directly managing the core areas while coordinating the staff function , mainly Quality, Commercial team and Business Development so to grant the full accomplishment of the company mission.

Main accomplishment of the year was the fast launch of the two COVID-19 vaccines (AZ-J&J) and the flawless and continuous support to commercial volumes without any business interruptions.

Major challenge was the site growth (from 554 to 890 employees) keep working on the site culture despite the remote working requested by the pandemic

Direct Report to the Bio -Europe President

Bristol Myers Squibb ( July 2014-Dec 2019)

Site General Manager with the responsibility of 700 human resources.

Direct Report to the Pharma Vice President

Bristol Myers Squibb ( July 2013-July 2014)

Operation Director with the responsibility of 600 human resources with the main following duties:

•             Budget for Operation 

•             Planning and fine scheduling of the production plans

•             Routine and extraordinary maintenance of the equipment’s/systems

•             OPEX (operational Excellence) and PMO (Project Management)

Direct Report to the Site General Manager

Bristol Myers Squibb ( April 2012-July 2013)

Director of Sterile Business Unit with the responsibility of 170 human resources (production, maintenance, production planning), with the main following duties:

•             Budget and Strategic Planning for Sterile  Unit

•             Planning and fine scheduling of the production plans according to Replenished planners and Customer service requirements

•             Production of sterile : powder, solution and suspension

•             Routine and extraordinary maintenance of the equipments/systems affecting the Sterile unit

Direct Report to Site General Manager

Bristol Myers Squibb ( May 2009 – April 2012)

Director of Quality Assurance and Quality Control units with the responsibility of 100 human resources, with the main following duties:

•             Budget and Strategic Planning for Quality Operations Unit

•             Product testing and release for EU, US, African and Asia Pacific Markets

•             Product Regulatory Compliance and Registration Dossier preparation (Chemical Manufacturing Section)

•             Markets Reference Contact for Product Registration and Distribution

•             Vendors and Internal Audit

•             Qualified Person (QP)

Direct Report to Quality Operation Senior Director EMEA and African Markets

Bristol Myers Squibb (May 2008- May 2009)

Pharmaceutical Technology Associate Director, with the responsibility of coordination of 9 sites located in France, Italy, China, Japan, Australia and Indonesia.

In addition to the previous engagement (Manufacturing Technology Senior Manager) mentioned duties:

•             Network consolidation within the different manufacturing sites, with related budget and strategic planning

•             Harmonization and consolidation of the technical practices within the sites and definition of the appropriate guidelines and directives.

Direct Report to Vice President of EMEA, and Asia Pacific Technical Operation

Bristol Myers Squibb ( Dicembre 2005- May 2008)

Manufacturing Technology Senior Manager with the responsibility of 13 human resources.

In charge for the two BMS Italian sites: (Anagni and Sermoneta) for the following activities:

•             New Product introduction

•             Technology Transfer (in/out) within BMS and from Third Part Manufacturing

•             Process Trouble-shooting and route cause identification in process deviation. 

•             Process Continuous Improvement with new technologies introduction 

Direct Report to Manufacturing Technology Senior Director

CTP Tecnologie di Processo (2003 – 2005)

Pharmaceutical consultant in charge for the Quality Development Department  of the Central Italy area with the responsibility of 30 human resources. Main duties:

•             Budget and Strategic planning of the Area activities

•                Harmonization and consolidation of the technical practices and definition of the appropriate guidelines and directives.

•             Planning and execution of the technical training for pharmaceutical personnel and Public officers (AIFA and Instituto Superiore di Sanità)

•             Technical support to the Commercial Unit

Direct Report to President of the Technical Operation

 Chiesi Farmaceutici 2000-2003:

Manufacturing Technology Manager with the coordination of three human resources and responsibility of:

•             Process Validation Master Plan

•             Scale up from  Research & Development (R&D) to Industrial scale

•             Vendor Due Diligence Audit

•             New Product Introduction

Personally involved in the start up of the following projects:

•             Blow Fill and Seal department for the manufacture of a sterile suspension for aerosol administration

•             MDI (metered dose inhaler) HFA (hydro Fluoro Alcane) 

Direct Report to site General Manager

 Chiesi Farmaceutici (1997-2000):

Project Leader with the responsibility of:

•             Start up of a new facility for manufacture of sterile endotracheal suspension for US and EU markets

•             Main duties of the role:

o            Process, Equipment and Cleaning validation

o            Aseptic Process Validation (Media Fill)

Direct Report to the Quality Assurance Director

Lepetit, Hoechst Marion Rousse (1994-1996) 

Process Development Chemist, with the responsibility of:

•             New Product/Technologies Introduction and Validation from pilot batches to industrial scale

•             Manufacturing process optimization

•                Process Trouble-shooting and route cause identification in process deviation

•             Technical Documents setting for filing submission

Direct Report to the Manufacturing Technology Senior Manager

Research activities:

•             Graduation Thesis, 1991:

“Study through Nuclear Magnetic Resonance (NMR) of the brain metabolic process: Cerebral Ischemia“

•             Master in Biotechnology promoted by Minister of University and Scientific and technologic Research  1992-1994

Rome, University La Sapienza, CNR Montelibretti

Polybios Trieste

                         National Institute of Health (NHI) Bethesda Maryland US

“Characterization of Microbial Polysaccharide Gellan through different spectroscopic techniques”