Irene Bermejo Diez

Technical Product Transfer Specialist with wide experience in the pharmaceutical industry. Demonstrated expertise in manufacturing science and technologies, process optimization and project management. Proven track record of leading successful product transfers and equipment qualification across international sites. Committed to excellence with a strong focus on efficiency, innovation and collaboration.

TECHNICAL PRODUCT TRANSFER SPECIALIST (TABLETS), MSAT OSD – GSK (ARANDA DE DUERO, SPAIN) Sep 2021 - Now Manufacturing Science and Technologies Oral Solid Dose. Responsible for: 

• Technical product transfers. Full high-containment production line. Transfer Risk Assessment. Evaluation of change controls. 

• Equipment & utilities qualification and validation. Lead planning of both projects. Deviation and CAPA management. 

• Product process optimizations (Design of Experiment & Design Space – computer-based simulation, model and analysis) 

• Process validation. Author of Technical reports, process validation protocols, reports and new Master Batch Records. Implementation of electronical Batch Record. • Subject Matter Expert (SME) for transferred products. Support on trouble-shoot, investigations (DMAIC approach), change control, improvements, Technical Risk Assessment. 

• Coordinate and lead continuous improvement projects (new excipients, new material introduction, stability studies and technical lab creation). 

• Support compliance inspections and enquiries from regulatory agencies 

PROJECT MANAGER (PACKAGING), NPI (NEW PRODUCT INTRODUCTION) - GSK (ARANDA DE DUERO, SPAIN) Mar 2023 – Sep 2023 Pilot development program to work in other departments. Manage project “Pivotal stability of a new tablet strength in blister”. Lead Aranda team (manufacturing, MSAT, supply logistics, etc.) into the preparation and delivery of the pivotal stability study for Central GSK. Point-of-contact for central GSK and supplier team. Accountable for delivery and timelines achievement.

PROCESS ENGINEER (STERILE), GLOBAL MSAT – GSK VACCINES (WAVRE, BELGIUM) / (CONSULTYS) Mar 2021 – Sep 2021 Global Industrial Operations (GIO) – Manufacturing Technologies & Validation (MSAT-MT&V). Responsible for: 

• Purchase and qualify primary and secondary equipment for Global Vaccine production (aseptic processes & use of single use). 

• Manage project and lead equipment planning. 

SCIENTIFIC WRITER (STERILE), GLOBAL MSAT – GSK VACCINES (WAVRE, BELGIUM) / (CONSULTYS) Aug 2018 – Mar 2021 Global Industrial Operations (GIO) – Manufacturing Technologies & Validation (MSAT-MT&V). 

• Part of the Technology Watch/Innovation core activity, author of technologies description, readiness level and supplier benchmarking. PAT/New Technologies Subgroup Leader of the oldest GSK vaccines Process Modernization Work Group. Author of a conceptual report of PAT/new sensors which could monitor, control and give process knowledge on the improved production process. Cooperation with Global QC (QC of the future), process expert on the current process and TR&D. 

• Responsible to deliver a Data Criticality Determination and System Specific Libraries databases of several equipment of the production line (primary – upstream & downstream - and secondary – packaging & fill/finish) at global level which includes process steps, critical parameters (i.e. CQA, CPP), critical data and alarms. Participation on System Validation RA. 

• Feasibility study of Raman and NIR technologies on the formulation step of the highest profitable GSK vaccine to avoid waiting time of QC test and storage. In charge of the purchase of Raman and FTIR instruments, their qualification and organization/planning of the delivery and trainings. Likewise, member of different PAT groups. 

• Technical Standards Organization (Strategic planning and managing). Review and participation on the creation of several GUI/V/G-SOP/training packages (documentation cycle creation, update and obsolescence). 

• Participation in several CAPA management and closure (vessel troubleshooting and two global mappings (filling and freezedrying)).

Master of Molecular and Cellular Life Science (2016 – 2018), VRIJE UNIVERSITAIT BRUSSEL (VUB), Belgium. Cum Laude 

Bachelor in Biological Science (2013 – 2016), UNIVERSITÉ LIBRE DE BRUXELLES (ULB), Belgium.