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Centered Medace Profile Picture of Albert Scherpbier

Albert Scherpbier

Chief Executive Officer (a.i.)

prof. dr. Albert Scherpbier
CEO (a.i)

Albert Scherpbier (1954) studied Medicine in Groningen. After his study he worked as coordinator of education in the surgical department at UMCG for 10 years. In 1991 he moved to Maastricht and became head of the Skillslab, where he also started to do research in medical education. In 2001 he became head of the Institute for medical education and professor in quality improvement in medical education. In 2011 he became the dean of the Faculty, Health, Medicine and Life sciences and vice chair of the MUMC. He supervised 70 PhD students and (co) authored 500 papers. He also was chair of several committees.

Centered Profile Picture of Yvo Graus

Yvo Graus

Chief Business Officer (a.i.)

Yvo Graus
CBO (a.i.)
Chris Duxbury

Chris Duxbury

Manager Facility and Technical Engineering

Chris Duxbury makes sure that all the facilities and technical aspects in the Medace facilities run smoothly. Combining both his scientific expertise and projectmanagement skills, Chris has made a great effort in the design and development of the medical device and ATMP cleanroom facilities at Medace, in which he applied best practices seen in earlier developed facilities.

Chris studied at the University of Nottingham where he gained a PhD in Chemistry. He moved to the Netherlands and held post-doctoral fellowships within the field of polymer chemistry at Royal DSM. After these fellowships he started working at DSM’s materials research department with a focus on the biomedical business unit. In 2015 he took up the responsibility to design, build and subsequently manage the biomedical facility of the public-private Institute for Science and Technology in Geleen (InSciTe). Parallel to these activities Chris played an important role in the process of obtaining ISO 13485 certification for InSciTe’s Biomedical Program.

Chris lives close to the facility in Maastricht and enjoys his daily bike ride from home to work. “ It’s a joy to be working in this vibrating heart of the medical hub in Maastricht, with so many different people with so many different expertises. We can really make things happen here.“

Dyanne Dohmen

Manager Accounting & Reporting

Dyanne takes care of Medace's financial administration and guarantees timely payment of obligations and accurate reporting to management.

Dyanne graduated from the HBO Business Economics in Sittard. Immediately after her studies she started working at DSM where she worked for 26 years as a financial controller in various departments and projects. Then she started working for knowledge institute Chemelot InSciTe in April 2018.

She enjoys the interaction with all the diverse companies working at Medace.
'I am proud to be able to add a little value to this promising company in this beautiful working environment.’

Jean Blom

Quality Manager

Jean Blom is accountable for the daily quality assurance activities as Medace’s Quality Management Representative for the certified ISO 13485 QMS of its Maastricht facility. He provides the strategy regarding Medace’s medical device clients, stepping into planning, coordination, and execution of quality support activities where necessary. He also serves as the principal expert regarding quality requirements as defined by standards and regulations such as the EU’s MDR.

Jean has over 11 years of experience in the Medical Device industry; from the hands-on quality and regulatory activities in start-up MyDiagnostick, through the quality coordination and system compliance architecture aspects of established business D.O.R.C. who had an extremely wide and varied product portfolio, to the accredited certification activities of ISO 13485. This is enhanced by his knowledge from the time in his master’s in international business Managerial Decision-Making and Control (formerly Controlling). In that time he became Lead Auditor and Audit Programme Manager, managed ISO 13485 remediation, scope extension and full-scope MDSAP implementation projects, and became Technical Expert. That combined experience is also employed to train others in advanced quality aspects and to evaluate the adherence of personnel to a QMS as internal or supplier auditors.

Jean enjoys ballroom dancing, reading, riding his Honda CB650R, and playing Dungeons and Dragons.

Coaching and mentoring comes naturally to Jean, where he takes the path of teaching things slowly so you can learn to do them smoothly. He enjoys the excellent alignment of his character in this with Medace’s mission of working together to enable learning, which accelerates successful innovative Medtech.

Youri van de Beek

QA Officer

Youri van de Beek is responsible for maintaining and improving the Quality Management System on a daily basis. Youri assists projects and clients within Medace by reviewing and updating documentation and completing technical files from a quality point of view.

Youri studied Laboratory Technique at the Vista College and spent his internships at the Uniklinik in Aachen and the Zuyderland hospital in Heerlen. In 2018 Youri started working for the Chemelot Institute for Science and Technology. Being involved in the quality team of their biomedical facility, Youri and his team members made a natural transfer to Medace at the end of 2019. At Medace he is now active as a full-fledged QA Officer by supporting implementation of guidelines and regulations.

Youri also provides introductory training for clients’ team members who will be working within the facility. ‘I enjoy working in a small team that still manages to do so much. Being a part of that and supporting others pushes me to develop into a Quality Officer that is able to support multiple projects and companies at the same time.’

Rianne Thomassen

QA Officer

Rianne is one of the Biotech Associates at Medace. Within the Operations team, she is responsible for the maintenance of the facility, providing training to Clients, and supporting with various clients daily operations with a primary focus on GMP production processes in the cleanrooms.

Rianne studied at Zuyd Hogeschool in Heerlen, where she obtained a Bachelor of Science degree in Applied Science, with a specialty in Biomedical Science. Her graduation internship took place at Neuroplast where she researched on the possible usage of the Monocyte Activation Test as a sterility test for their ATMP product (Advanced Therapy Medicinal product). After graduating, she joined Neuroplast as a Biotech Associate, where she got hands on experience on manufacturing an ATMP product compliant to the EU GMP regulations. She also took active participation in writing and dealing with non-conformities, corrective and preventive actions, change controls, and updating batch related/other GMP documentation. Prior to joining Medace, Rianne worked at the Central Diagnostic Lab within MUMC+ where she performed blood, urine and liquor tests and maintained the highest quality test results while working with the patient materials.

Rianne thrives in the dynamic environment at Medace, where a multitude of companies are working on innovation and development. These fuel her passion for innovation and problem-solving which she will deploy to help with the challenges the clients are facing, and contribute towards their success.

Linda van Leeuwen

Regulatory Affairs Associate

Linda is responsible for supporting clients regarding the matters related to the regulatory compliance of their product and product development. This is achieved by advising, reviewing and teaching within client-focused projects, and by improvement and updates of the Medace QMS used for clients.

Linda graduated as BSc from Hogeschool Rotterdam as a biomedical research technician. She started her career at IsoTis BV where she worked on skin and bone tissue engineering. Her experience continued at the University of Utrecht, where she worked at the department of Immunology as technician in a project of the Dutch Asthma Fund. After the project ended, Linda decided to return to a company setting and did research at start-up Progentix Orthobiology BV (now known as Kuros Biosciences BV). In this job Linda performed tasks such as setting up an ordering system, histology, pre-clinical studies, shelf-life studies and coordinating clinical trials. During this time she got acquainted with the field of regulatory affairs, and after more than 10 years in research, she moved to D.O.R.C. to enhance her career in regulatory affairs of medical devices. At D.O.R.C. she was responsible for the regulatory side of product development and product changes, as well as regulatory intelligence, CE certification and 510(k) clearances, technical file maintenance of ophthalmic surgery devices ranging from class I to class IIb, from reusable to sterile, from short-term use to implantable and active devices with software.

At Medace Linda hopes to combine the experiences gained at start-up companies with her laboratory background and wide knowledge of medical device regulatory affairs to advise and teach other medical device start-ups and help them get their product to market in an efficient and compliant way.

hans henskens, qualified person

Hans Henskens

Qualified Person & Senior Quality Associate

Hans Henskens is supporting our clients in releasing their final product as QP (Qualified Person), ensuring that the product is safe to use and meets all required specifications. Next to this he supports the rest of the Quality Assurance teams of Medace and her clients in maintaining the Medace Quality Management System according to the current legislation and standards. Hans provides expert support and implementation guidance on tailor-made documentation while our customers are developing their Advanced Therapy Medicinal Products (ATMPs) at Medace enabling them to obtain their own manufacturing license and perform clinical trials with their products.

Hans initially got his teacher training degree in Tilburg, after this he broadened his experience in Molecular (cell) Biology by earning his master’s degree in molecular biology in Nijmegen and subsequent doctorate from the Free University of Amsterdam. After his PhD he has gained extensive experience in the innovative pharmaceutical industry, more specifically within Quality Assurance and Quality Control. His first role as QP was for generic medication but thereafter he managed several QA/QA departments besides his QP responsibility. At the beginning of his career, he gained much experience during his 10-year employment at Synthon, an innovative Biopharmaceutical Company. Later he acquired extensive experience in the field of ATMPs as QP of PharmaCell and subsequently Lonza Netherlands, a Cell and gene therapy CMO. After his time at Lonza he was employed Chief Quality Officer / QP for Glycostem Therapeutics, an innovative company developing stem cell-derived Natural Killer cells for an allogenic cell therapy product as s a medicinal asset in the fight against cancer. Throughout his working life, he has ensured that these companies passed various authority inspections.

Hans values the combination of several innovative emerging Biotech companies, enabling synergy and accelerated development. ‘’It’s highly motivating to work in the Medace ecosystem and being able to support multiple development trajectories at the same time to achieve our joined objectives.’’

Marco Schaaf

Quality Associate GMP, Quality Manager GMP a.i.

Marco is Quality Associate GMP at Medace. He supports clients with their quality-related needs, thereby aiding their company developments. A well-established Quality Management System is a prerequisite to warrant consistent manufacturing and product quality to secure patient safety.

Marco is driven by biomedical applications that could improve treatment outcomes and quality of life. After graduating the Clinical Molecular Sciences master (2010), Marco pursued unravelling cellular means that sustain therapy-thwarting features of the tumor microenvironment. Herein, the research revolved around intracellular vesicle trafficking systems called autophagy and the endo-lysosomal pathway. First as PhD student at Maastricht University and later on as post-doc at KU Leuven. In 2019, Marco started at Neuroplast in the position of Quality Control Manager. Neuroplast produced an ATMP (GMP-compliant) for treatment of traumatic spinal cord injured patients in phase 1 and phase 2 clinical studies. In this position, Marco got experienced with the requirements of GMP, running a compliant lab facility and the structured Quality Management System.

Together, this collective of experiences in academic (pre-clinical) studies and GMP-compliant manufacturing and quality control is a great foundation for his position within the Quality team at Medace. Marco is excited to provide tailored quality support to start-ups to bring the medical innovative concepts to clinical application in a compliant way.

Gert Poludniak

Biotech Associate

Gert is one of the Biotech Associates within Medace. Together with the Operations team he is responsible for maintaining the facility, providing training, and assisting clients in their daily operations, mainly focusing on the aspects of tech transfer and process development for ATMPs.

Gert obtained a BSc degree in Agro- and Biotechnology at PXL Hogeschool followed up by a BSc degree in Biochemistry & Biotechnology at the University of Antwerp. He did a graduation internship at the department of experimental oncology in the Gasthuisberg campus, Leuven.

Since then, Gert has gained over 5 years of experience working in a GMP environment, starting as a QC analyst in a small molecule API production plant. Here he learnt the basics of GMP lab work, quality assurance and structure of a pharmaceutical company. The next step was moving back to the field of biotechnology and gaining a broader insight in pharmaceutical production. This was achieved by joining a pre-clinical ATMP startup and aiding in product development as well as building a QMS. In this diverse role Gert worked on various tasks including hands on experience with pre-clinical studies, aseptic manufacturing in grade-B cleanroom, handling of non-conformities, CAPAs, and change controls which resulted in a GMP certification for the company and an NK-cell culturing process with yields far exceeding competitors.

“I get energized from building efficient processes, having the opportunity at Medace to help multiple companies simultaneously to reach their goals is a perfect fit!”

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