Raquel Fortunato is the Chief Executive Officer of GenIbet and a member of its Board of Directors. Her main responsibilities are multidisciplinary: Business Development, Strategic Management and Client Interface. GenIbet’s CEO is a Chemical Engineer with a PhD in Biochemical Engineering and a Post-Graduate education in General Management with more than 15 years of experience in project management of Research and Development Projects, budget implementation, technical support to process operations and team coordination.
The Qualified Person/Technical Director guarantees that API and Investigational Medicinal Products are produced and analysed according to the cGMP and the approved specifications and is responsible for the final release of the product. Both Genibet QPs are graduated in Pharmaceutical Sciences with the Title of Specialist in Pharmaceutical Industry given by Ordem dos Farmacêuticos and have more than 20 years of experience. Both are certified by Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. (INFARMED), according to the Portuguese legislation.
The Qualified Person/Technical Director guarantees that API and Investigational Medicinal Products are produced and analysed according to the cGMP and the approved specifications and is responsible for the final release of the product. Both Genibet QPs are graduated in Pharmaceutical Sciences with the Title of Specialist in Pharmaceutical Industry given by Ordem dos Farmacêuticos and have more than 20 years of experience. Both are certified by Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. (INFARMED), according to the Portuguese legislation.
António Cunha is a Chemical Engineer with more than 30 years of experience in biotechnological processes, development and scale-up. António has been working for iBET since its creation 30 years ago and lead the Pilot Plant from the Institute. António was also part of the core team that set up GenIbet and acted as GenIbet production director until June 2019 when the company was restructured and António took up a broader role as Process and Compliance Advisor.
The Production and Operations Department of GenIbet is managed by Tiago Ferreira, a Biotechnology Engineer (U. Lusófona) with a PhD in Chemical Engineering (FCT-NOVA) and almost 20 years of experience in the optimization and scale-up of biotechnology processes. Tiago joined GenIbet in 2006 and was also part of the core team that set up GenIbet. Before becoming Production and Operations Director in June 2019, Tiago held different roles in GenIbet organization namely in QA, Project management and Business Development.
Tiago leads a team of more than 20 qualified and trained Bioprocess Specialists and Technicians with diverse backgrounds Chemical and Biotechnology engineers, biochemists and biologists. GenIbet favours providing visibility to the personnel on-the-floor to the context, framework and future application of the products being manufactured as this increases team engagement, sense of urgency and acuteness to handle potential problems. Clients and Partners are therefore encouraged to share the most amount of context information on their projects as possible.
The Project Management and Tech Transfer Department is managed by Bárbara Cunha. She is a Biochemist (FCUL) with a master’s degree in biotechnology (FCT-NOVA) and a PhD in Bioengineering (MIT-Portugal) with more than 10 years of experience in the manufacturing of biopharmaceuticals. Bárbara has worked at GSK where she was involved in establishing and characterising purification processes from 0.2 up to 200 L for the purification of lentiviral vectors and later as a Vector Lead in two oncology clinical programs, where she established the strategy for plasmid and viral vector for these projects, conducted process development and successful GMP manufacturing for Pilot studies (US and Europe).
GenIbet has dedicated project managers (PM) per Client/project which are responsible for the initial tech transfer and the subsequent transfer to the manufacturing area. The PMs are in close contact with the Clients throughout the entire project on a regular basis and whenever required. The Clients are regularly informed via e-mails, e-conferencing and other means deemed necessary on the “work in progress”. All PMs at GenIbet have more than 10 years of experience.
The Quality Assurance Department of GenIbet is managed by Bruna Albuquerque, a Chemical and Biochemical Engineer (FCT-NOVA) with post-graduate studies in Environmental Health and Safety and more than 10 years of experience in Quality Assurance in the pharmaceutical industry. This Department is divided in 2 main areas: QA Operations and QA Systems with teams of various backgrounds (e.g. pharmacists, biochemical engineers) all with several years of experience in the Pharmaceutical industry.
QA Operations personnel is dedicated to one or more projects/Clients and supports the Project managers in Quality Related communications with the Clients and in the design and definition of processes and documents in accordance with the QMS and the GMPs. QA Systems personnel oversee all the QMS system. Periodic QMS revision is done to assure the adequacy and effectiveness of the system. The QA systems are is led by Jessica Teixeira, a Pharmacist (Universidad Central de Venezuela) with more than 14 years of experience in Quality Control, Clinical research and Quality Assurance in the Generics and Transnational pharmaceutical industry (Novartis Venezuela 2013-2018).
The Quality Control Department of GenIbet is managed by Ana Rita Marques, a biologist (FCUL) with a PhD in Biotechnology, and more than 8 years of experience in the in vitro pharmacology group of a biotechnology company, where she was responsible for leading drug development R&D projects. Ana Rita has been responsible for the Quality Control area at GenIbet since 2011. Ana Rita oversees a team of people with diverse backgrounds from A-Level with several years of experience in the Pharmaceutical industry to Chemical and Biotechnology engineers and biochemists. This Department is organized in 4 main areas: Warehouse & Logistics, Internal Documentation Management, Testing Lab and Projects’ Management. Mariana Almeida (PhD in Microbiology, Immunology & Inflammation from Columbia University, New York) is the QC Project Manager and supports the other Project Managers on their interaction with customers on the particular points of the Quality Control analysis to be performed for the different manufactured products, based on the Eur. Ph. and Products application (specification)/risk assessment.
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