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- ...The Director CMC External Development Services Lead will be a key contributor to enabling and driving external technical development across BioNTech’s product pipelines and modalities. He/she will lead a small team of CDMO managers and CMC technology transfer managers...Empfohlen
- ...transfer packages, and regulatory support documentation Collaborate closely with internal stakeholders such as Technical Development/CMC teams as well as external CDMOs/CMOs to ensure seamless communication and alignment Contribute to harmonization of processes...EmpfohlenPhD
- ...Your responsibilities: · Represent analytics in interdisciplinary teams and act as single point of contact for the CMC team and all relevant stakeholders. · Ensure successful management of all analytical activities and actively report the status (progresses...EmpfohlenPhD
- ...korrekt Dokumentation & Vorgangsverwaltung: Sie bearbeiten Eingangskorrespondenz und pflegen alle Vorgänge übersichtlich im System CMC Claim Manager Informationsbeschaffung: Sie fordern gezielt notwendige Unterlagen an – Unfallberichte, KFZ-Gutachten,...EmpfohlenBefristete ArbeitZeitarbeitAb sofort
- ...stakeholders Tracking of milestones, timelines and budget Actively engage with cross-functional teams, manufacturing, automation, QA, QC, CMC, R&D, MS&T, AS&T, IT, other BioNTech departments and external suppliers, to foster collaboration and ensure seamless integration to...Empfohlen
- ...stage and commercial products, including RNA and antibody-based therapeutics. Acts as the accountable MS&T representative for the CMC interface and key point of contact for strategic partnerships, ensuring alignment with BioNTech’s business objectives and regulatory...Empfohlen
- ...Strategy & Demand: • Drive the development and implementation of category strategies in collaboration with business stakeholders, such as CMC, ESO, Supply Chain, Legal and QA. • Identify and assess global business needs, proactively engaging with the business to achieve...EmpfohlenVollzeit
- ...des Änderungsmanagements von Transferprojekten durch regulatorische Fachkenntnisse zu vorhandenen Produktdossiers Erstellung von CMC-Regulierungsdokumenten/-dossiers zur Einreichung, indem wissenschaftliche Inhalte in konsistente CMC-Sprache und optimierte Terminologie...EmpfohlenPromotionFlexible ArbeitszeitenFrühschicht
- ...development, accelerated approvals, lifecycle optimization, and sustainable compliance. Working closely with Development, Clinical, CMC, Safety, Market Access, Commercial, and Global Regulatory colleagues, the Director will provide strategic leadership for major...Empfohlen
- ...in life sciences with extensive domain knowledge in drug discovery (target ID through lead optimization), preclinical development, CMC (all drug modalities), or product quality testing. Proven track record of defining, designing, prototyping, and implementing productized...EmpfohlenVollzeitPhDHomeoffice
- ...validation campaigns, robustness studies, and process improvement projects Participate in technology transfer activities between R&D CMC and manufacturing, leveraging the co-located R&D site Develop and maintain process engineering standards and practices (P&IDs,...Empfohlen
€ 79.104 - € 105.472
...validation campaigns, robustness studies, and process improvement projects Participate in technology transfer activities between R&D CMC and manufacturing, leveraging the co-located R&D site Develop and maintain process engineering standards and practices (P&IDs,...EmpfohlenVollzeit- ...standortinterne Projektteam und an das globale Deployment-Team Qualifikationen DU… bringst Erfahrung mit klinischen Studien, CMC-Projektmanagement, Scale-Up und Tech-Transfer im Zusammenhang mit der Entwicklung und Zulassung von Biotech-Wirkstoffen und...EmpfohlenUnbefristete ArbeitVollzeitMobiles ArbeitenFlexible Arbeitszeiten
- ...product, digital health and in-vitro diagnostic (IVD) products within the Sanofi portfolio of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The GRA Device organization serves as a critical strategic partner within Sanofi's regulatory...EmpfohlenHybrides Arbeitsmodell
- ...gutes Verständnis regulatorischer Entwicklungsprozesse über den gesamten Produktlebenszyklus hinweg Fundierte Kenntnisse im Bereich CMC (Chemistry, Manufacturing & Controls) Erfahrung in mindestens einem der folgenden Therapiegebiete:OnkologieZNS / NeurologieCardio-...EmpfohlenVollzeit