CMC Director in Project and Product Management (PPM) a.i.
Since June 2014
Member of the Astellas Global Project and Product Management (PPM) organization. Responsible of projects in the field of "Chemical Manufacturing & Control" for regional and national pharmaceutical and cosmeceutical products, belonging to the category of solid oral products, semisolids and liquids for topical use, injectable aseptic and terminally sterilized products. The projects cover technology, regulatory, qualitative and logistic aspects related to the specific portfolio of products.
Director Industrial Operations
September 2013 --- March 2014
The position has the report of the Production Department, the Engineering & Technical Services Department, the Planning and Logistic Department and the Quality Control Department with a total of 200 employees. Among the Technical Services are included the Engineering, Safety and Environment activities, with total 40 employees. The Director Industrial Operations is in charge of the evaluation of every new business opportunity for both the technological aspects and the industrial effectiveness in both the Abano Terme Site and the Noto Local Unit (Siracuse, Italy), acting also as one of the Qualified Persons for the Abano Terme Site. The factory is focused in manufacturing of fermentative and natural origin active principle ingredients, production of semisolid products, injectables products both aseptic and terminally sterilized, solid oral products, medicated gauzes, lyophilized sterile vaccines. The product portfolio is made of pharmaceuticals and medical devices distributed worldwide by Fidia and its partners and licensees, as well as a significant production made on behalf of world leading pharmaceutical companies. To the above mentioned internal production, we must add the solid oral products, pressurized products and injectables products belonging to the category of pharmaceuticals, medical devices and food supplements manufactured by a network of qualified contract manufacturers.
Director Quality & Technology Contract Manufacturing Management
April 2010 --- August 2013
• Life cycle management of the outsourced portfolio of products in the EU Region (about 40 CMOs, turnover about €300 m). • Responsibility for technological maintenance and management of all change control aspects (including CRO management for process development and troubleshooting). • Lead technological part of cost reduction projects, including selection of and outsourcing to new CMOs, technology transfer and support of related regulatory changes. • Management of the intellectual property aspects related to the Contract Manufacturing products portfolio. • Management of Contract Manufacturing QA function o Management of quality/technical agreements structure with CMOs, Astellas sales affiliates and license partners. o CMO management plan including audit strategy, risk assessments, design of change control processes, use of TrackWise system, complaint handling and quality monitoring. • Global auditor for Astellas: auditing of drug product and active pharmaceutical ingredient manufacturers worldwide. • Leading quality improvement plans at CMOs • Chair of regulatory affairs document review committee. • Prepare CMOs for Authority inspections (EMA, FDA) and license partner audits. • Development and implementation of ICH Q10 within the EU Contract Manufacturing Management Organization.
October 2003 --- April 2010
The position has the report of the Production Department, the Engineering & Technical Services Department and the Planning and Logistic Department with a total of 95 employees. Among the Technical Services are included the ICT, Safety and Environment activities, with total 12 employees. The Planning and Logistic Department includes also the SAP System management and the Purchasing Department, with total 13 employees. The Technical Direction is in charge of the evaluation of every new business opportunity for both the technological aspects and the industrial costing. The factory is focused into the manufacturing of semisolid products with a volume of 25 million units, made of pharmaceuticals and cosmeceuticals distributed in Europe and the major markets in Asia, Africa and Australia. The Plant delivers also a significant production of liquids for topical use, suppositories and ovules. To the above mentioned internal production, 2 million units of solid products and medicated foams produced by third parties must be added.
July 1998 --- October 2003
Technical Director and Qualified Person for Dompé S.p.a. at L’Aquila Pharmaceutical Manufacturing Plant. The position has the report of the Production Department, the Quality Control Department, the Warehouse Department and the Planning and Logistic Responsible with a total of 84 employees. The Production Department includes also the Production technical maintenance. The Plant includes the production of semisolids, granulates into sachets, liquids for topical and oral administration. The Technical Direction is also responsible for industrialization of new products, external manufacturing and third party manufacturing of liquid oral products, medicated foams, suppositories and injectables.
Quality Trends Manager
January 1996 --- January 1998
Chemistry and Pharmaceutical Technology in Pharmacy, Chemistry and Technology from Sapienza Università di Roma in 1991