Toledo, Castile-La Mancha, Spain
I am a Biologist, PhD in Medicine with more than 15 years of experience in the pharmaceutical industry. Along over these years I have successfully led Production and Quality Control teams, collaborating actively in the growth and talent development helping the team to offer their best version. I have carried out my responsibility in demanding and changing environments, with growth and expansion challenges in different companies dedicated to the production of vaccines for human and veterinary use, commercial advanced cell therapy drugs and large-scale production scale of recombinant proteins and antibodies. Science is my passion, that the reason for starting my career professional in research, with a strong commitment to health and the patients, that I am happy and proud to have been able to develop in the pharma industry. I have led projects strategic teams made up of high-impact multidisciplinary teams applying tools of operational excellence for improving process efficiency.
As a Technical Project Manager, I have had the responsibility for successfully achieving of the program/project objectives of a technology transfer for manufacturing a drug product with a promising future in the treatment of cancer. As project leader, I have acted as the main point of contact with customer ensuring alignment between project decisions and CZ Vaccines' global strategy. I have successfully managed the customer relationship, facilitated meetings and ensured coordination and alignment between the different areas involved (Production, Quality, Supply Chain). In addition to this main role, I have played a dual advisory role to the Production area, actively collaborating in the design of operations and preparation of technical documentation, and approach to validation dossiers, as well as the design of feasibility protocols for analytical techniques, specifications etc With direct reporting line to the director of Technology Transfer. At this stage, the execution of the aseptic validation and process validation batches has been carried out, as a prior phase to the manufacturing of the GMP batch for clinical trials in phase II and III.
As Mfg Operations Sr Manager (Associated Director), I have been responsible and accountable for the Manufacturing Operations team, leading following departments: Seed Train, Upstream (USP) Downstream (DSP) and Manufacturing Support (Material preparation, SAP, etc), with responsibility in production performance, (operations & people). With around 10-13 direct reports and more than 170 indirect reports, I was reporting to the Sr Manufacturing Head. I have been representative in Safety Committee and as leader in innovation strategic project for the site, and as sponsor in different Mfg projects with impact in safety and cost reduction KPI’s.
As Manufacturing Head, I have been responsible and accountable for the Manufacturing Team, leading following section: isolation and cell banking, active product ingredients and final products. With 2 direct reports and 26 indirect reports, I was reporting directly to the Site Head. I have been directly involved in transfer process for new sites in Ireland (Grange Castle) and Japan (Osaka) as new Cell Therapy Centres, being strategic point for the Takeda Business Unit.
As Production Manager I have been responsible and accountable for Production team, leading following sections: planning, production of APIs, Bulk drug substances, and formulation/filling processes and logistic distribution for sterile and non-sterile vaccines and diagnostic devices for human and veterinary use. With 4 direct reports and 35 indirect reports, I was reporting directly to the CEO.