Èlia Colet

API + FDF. Licensing Manager. Responsible for Co-partnerships & Contract Services projects. *B2B FDF/API Sales: - Responsible for the areas of LATAM, South Africa & Spain. - Out-licensing and API sales. - Supply and licensing agreements. - Dealing with agents - New business opportunities evaluation (business case) - Interaction with other internal department during the life-cycle of the project in order to support the customer from any point of view (Regulatory Affairs, Market research, IP, Legal, R&D, Supply Chain, Quality, Operations) - Attending trade fairs of the sector. *API intermediates: - Responsible for promoting intermediates from the Chinese manufacturing facility *Contract Manufacturing: - Responsible for promoting and managing all contract services opportunities (FDF + API). - IP driven opportunities. *Co-partnerships: - Responsible for coordinating all the partnerships with third parties. - Identifying new potential partnerships. - Monitoring the on-going opportunities. - Define sales strategy with the partners (key customers, business model, etc). - Supervise project clearance

Head of Contract Services business unit (FDF&API) Taking advantage of the company manufacturing sites located in Malta, promoting and detecting the best IP driven opportunities. Heading a team of 2 people. Dealing with national & international customers (EMEA, USA). Attending trade fairs of the sector. Presenting strategic plans of the Business Unit to the board. Participating in strategic company meetings. Member of the Operative Committee.

Development of a lean six sigma project

Management of group production sites transfers. Design and set-up a system to coordinate group transfer projects from a local point of view.. Liaison with the global transfer management. Define the key milestones of the project (stock coverage, launch orders, Lead times, quality and regulatory constrictions, resources, Transfer Prices, MOQ). Working with Supply department on anticipating potential Out Of Stocks and writeoff risk. Coordinate and assess the impact of regulatory variations and quality issues on the status of the project, and daily contact with the involved departments (Quality Assurance, Regulatory Affairs, Supply team, NPI team, Sales department, Global Supply Hub, Warehouse, BD). Leading weekly internal meetings to follow-up the status of the project. Performing global international meetings on periodic basis. - In terms of strategy, performing product by product business cases in order to assess the viability to perform the transfer, taking into account key milestones as supply agreements, exclusivity clauses, Transfer Price, MOQ, Service level, manufacturing capacity, technical/regulatory aspects. - Giving support to QA/RA departments, following up variations post-launch in order to assure a full compliance from a supply point of view. - As per BD request, performing external audits to potential contract manufacturing sites in terms of capacity (LT, OEE, equipments), service level (KPI) and technical aspects.

Coordination of manufacturing process. Reporting to Head of Production. - Coordinating production areas (dispensing area, manufacturing solid/liquid area, pellets area, primary and secondary packaging area). - Issuing production schedule (SAP system), according to the forecast and customer orders. - Leading OEE and SMED projects. Design and set-up an operational excellence project in the packaging area achieving the fixed goals. - Daily contact with Purchasing, Logistics, Warehouse, Regulatory, Quality Control and Quality Assurance departments. - Coordination of new manufacturing projects, working jointly with Development Department and Contract Manufacturing Department. - Key contact with Quality Assurance department; attending external and internal audits. Member of process/cleaning validation, compliance and change control team. - Maintenance of production documentation (Master Batch Documentation, validation/qualification reports, manufacturing formulae, Packaging Procedures, SOP¿s). - Performing several trainings to Production

Management of QA systems to ensure compliance with regulatory and corporate requirements.

Issuing / updating SOP and other quality documentation of production department. - Liaison with service suppliers to establish user requirements and Technical Agreements. Services as qualification of facilities (clean areas, HVAC system), calibration and external maintenance, out-sourced validations and qualifications. - Issuing and performing qualification protocols (DQ, IQ, OQ, PQ) of production equipment (filling machines, compressing machines, packaging lines, weighing equipment, reactors). - Issuing and performing cleaning and process validation protocols both prospective and retrospective ones, being member of the validation team. - Leading capacity studies of production equipment (CpK) and set-up a KPI system, working closely with production operators. - Annual Calibration Plan. - Providing new operators with GMP training. Performing further training to production operators regarding new rules and regulations.