Gene Therapy Release

il y a 2 semaines

Brainel'Alleud, Belgique UCB Temps plein

Make your mark for patientsWe are looking for a GT Release & Stability Specification Scientist who is detail-oriented, solution-driven, and collaborative to join our Gene Therapy Analytical Sciences (GTAS) team, based at our UCB campus in Braine-l’Alleud, Belgium.About the RoleYou will lead the strategy for release and stability specifications for gene therapy (GT) products. From preclinical development to commercialization, you will ensure analytical excellence and regulatory compliance across all project phases.Who You’ll Work WithYou’ll collaborate with cross-functional internal teams (Analytical Project Leads, Regulatory Affairs, QA, QC, etc.) and external partners. You’ll be part of a dynamic and innovative team committed to advancing gene therapies that make a difference in patients’ lives.What You’ll DoDefine and lead the release and stability specification strategy.Coordinate analytical studies for clinical batch release, stability, specification design, comparability, and reference standards qualification.Ensure on time and in full delivery of analytical documentation related to release, stability and comparability studies of Gene Therapy CMC batches.Support regulatory submissions, audits and inspections as requested by the business.Support all GT projects, from preclinical development to commercialization and lifecycle management, for activities related to release and stability specifications.Help develop the GT QC Testing team’s scientific and regulatory capabilities.Interested? For this role, we’re looking for the following background and skillsMaster’s Degree and expertise in analytical methods for biologics (molecular biology and/or physico-chemistry). Experience with viral vectors or other ATMPs is a plus.Strong understanding of GMP regulatory and quality requirements.Experience preparing analytical documents (CoA, specs, protocols, reports).Proficiency in statistical methods for specifications, stability and comparability management.Excellent project management and communication skills.Strategic thinker with strong problem-solving abilities.#genetherapyAre you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you 

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