Our team members come from companies that have been pioneers in the implementation of Quality Standards in the biotech and pharmaceutical industry. We are specialized in the development of Advanced Therapies and Innovative Medicines and we have been responsible for the fine tuning of the first processes in Spain for the manufacturing of Gene and Cell Therapy medicines for clinical trials.
Company
Leading consulting firm in the field. Professionals with more than 20 years of experience in helping our clients to develop new medicines that will improve people’s lives.
Gradocell is a client-centered company. In addition to providing our own services, we work with our clients and offer them, upon request, one-off collaboration with other companies with expertise in each of the project’s strategic areas: Engineering (for the design and set-up of facilities); CMOs for third-party manufacturing; CROs for the management of clinical trials; service companies (cleaning and maintenance of cleanrooms, etc.), etc. Because of Gradocell’s comprehensive consulting services, all of our clients can focus on their main objectives, because we offer them all the resources they need
Our Team
Our team is composed of highly-qualified professionals, pioneers and experts in the design of regulatory strategy, manufacturing, clinical trial approvals, and the marketing and authorization of medicines used for Advanced Therapies (Cell Therapy, Gene Therapy and Tissue Engineering) and Innovative Medicines.
She holds a Biological Sciences Degree from the Complutense University of Madrid and a Master’s Degree in Manufacturing and Applied Quality. She has more than 30 years of experience in the pharmaceutical field and in doing research on Advanced Therapies.
She worked for ten years as a Senior Research Technician at Antibiotics-Farma, SA, where she was responsible for the cell culture laboratory. She then specialized in stem cell culture at the National Center of Biotechnology (Consejo Superior de Investigaciones Científicas [Spanish National Research Council]), where she worked for three years.
After this, she joined the Cell Therapy Department of the Genetrix group, where she worked for four years in R&D until she transferred to the Cell Therapy Medicine Manufacturing Plant of Cellerix, SA (currently Takeda), where she worked as Head of Cell Therapy Medicine Manufacturing.
In 2010, she founded GRADOCELL SL, a consulting firm focused on providing advice and training in the field of Biotechnology, Advanced Therapies and Innovative Products, offering services of strategic, technical, regulatory and quality assurance design in the field of Advanced Therapies and Innovative Medicines. Gradocell also offers advice on business plans and strategy for companies in the field.
She is the current CEO and Technical Director of Gradocell, and also takes part in the Board Committees of several companies as a regulatory strategy consultant.
She holds a Degree in Pharmacy by the Complutense University of Madrid, a Master’s Degree on Management of Biotech Companies and an Expert Degree on Medicine Registry and Regulatory Affairs (CESIF).
She began her professional career in the R&D Project Management Department of the Genetrix group, being responsible for the national and regional calls for grants, as well as overseeing and managing R&D projects.
She then specialized in the implementation, maintenance and certification of Management Systems and Quality Assurance of the biotech companies within the GENETRIX group. She served more than seven years in CELLERIX (currently Takeda) as the Head of Quality Assurance of the pharmaceutical laboratory that manufactured GMP-compliant Cell Therapy Medicines.
In addition, she was Deputy Technical Director of the Pharmaceutical Laboratory for four years, being responsible for the release of cell therapy medicines to be used in clinical trials.
In 2010, she joined GRADOCELL SL as Quality Director, being responsible for Quality consulting services, implementation of GMP Quality Standards, regulatory advice, training and external audits, as well as other projects within the field of Innovative Medicines and Advanced Therapies.
She also teaches subjects on Pharmaceutical Regulations and Quality Systems specific to Advanced Therapies in university master’s degrees and postgraduate courses in the Francisco de Vitoria University, San Pablo CEU University and Carlos III University.
Industrial Engineer, specialized in Industrial Organization. He holds a Master’s Degree in Conflict Management and Mediation. He is an EFPA-certified Financial Advisor. He holds a diploma in Purchasing Management from CIPS (UK), in International Management from INSEAD, and in Leadership Development from CCL (Brussels), amongst other academic credentials.
With more than 30 years of professional experience, he has worked for two large multinational companies in different positions of responsibility: Management, Head of Department and Area and Team Coordinator, mostly in foreign countries, where he was responsible for strategic projects.
He has extensive international, interdisciplinary and intercultural experience and training, having held management positions in areas such as HR, Operations and Strategic Purchasing. Throughout his professional career, he has coordinated and implemented strategic and operational plans; cost and process optimization and reduction programs; outsourcing of services; management of travel and communication programs; as well as management improvement and talent development of the teams under his responsibility.
After spending five years working in different management areas as Interim Manager, Advisor and Independent Consultant for several companies, he joined GRADOCELL in 2017, where he is the Chief Financial Officer, also offering advice to clients on their strategic, operational and business development plans as well as in HR management and talent development.
She holds a Degree in Biological Sciences, with a double major in Neurobiology and Health Biology from the Complutense University of Madrid.
She holds a Master’s Degree in Biotech Management and Business Administration from CESIF, and is currently pursuing a PhD on Technology Transfer Indicators in Biomedicine at the Complutense University of Madrid.
She started her biotech professional career as a research assistant in the CSIC’s Ecology and Biology of Reproduction Group (GEBIR), after which she became the Head of Clinical Development and Industrial Property at Fina Biotech (previously Indas Biotech). She then became Project Manager of the spin-off of the University of the Balearic Islands, Sanifit Laboratoris.
In 2013, she founded Kinrel, a company specialized in innovation management and optimization of R&D projects.
With 14 years of experience in the clinical development of innovative medicines, she has been collaborating with Gradocell since 2014 as Regulatory Affairs Senior Consultant.
