Preclinical Development Manager ATMP
il y a 4 jours
Key Accountabilities:Evaluate the non-clinical safety aspects of candidate cell and gene therapy programs, performing gap analyses for external collaborators and clients;Offer ad-hoc non-clinical safety support and guidance on program development to partners and clients across a wide range of advanced therapy medicinal products;Plan, design, and execute non-clinical studies sponsored by Multithera or its partners, including GLP regulatory toxicology;Manage contract providers' selection and monitoring, ensuring compliance with project plans and budget;Compose non-clinical sections of regulatory documents for scientific advice meetings and clinical trial applications. Represent Multithera and collaborating organisations in meetings with associated health technology assessment (HTA) groups (both local and international);Support business development efforts through participation in meetings, conferences, proposal preparation, and grant application writing, meeting high standards and tight deadlines;Cultivate and maintain solid relationships and communication with vendors and collaborators;To review literature and attend conferences to keep abreast of developments in ATMP development, with a strong focus on pharmacology / toxicology;Create and review protocols and author study reports for non-clinical studies.KU Leuven Research & Development (LRD) builds bridges between science and society. As a technology transfer service of the KU Leuven Association, we guide scientists to put their research results at the service of society, the economy and the living environment. Our multidisciplinary team has a solid experience in setting up research collaborations, protecting and licensing intellectual property and establishing spin-offs. Through a unique network, we connect researchers with companies, but also with governments, investors and other organizations, so that we can respond together to the needs of society. In this way we are building a world ready for tomorrow, with today's excellent research. In the framework of the building of a unique translational hub named Multithera for the development and clinical translation of Advanced therapy medicinal products (ATMPs) LRD is looking for a CMC manager ATMP.We offer a full-time position with a permanent role in an innovative environment in the center of Leuven;A salary matching the job responsibilities and taking into account your experience;Additional benefits including free hospitalization and group insurance, additional holidays, bicycle allowance, free public transport and ecocheques;A hybrid working environment and teleworking allowance.
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Aarschot, Belgique KU Leuven Temps pleinThe applicant will have:A Bachelors degree in medical laboratory techniques, or equal by experience. Experience in working with cell culture models and conducting molecular/cellular biology techniques.Experience with handling and testing mice and conducting related biochemical assays.Experience with fluorescence microscopy is desirable but not a...
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il y a 1 semaine
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