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- ...transformation initiatives. This role involves collaborating with various departments to ensure data quality, consistency and stewardship across CMC processes. Your Contribution: Act as the primary point of contact for data-related queries within CMC,...EmpfohlenPhD
- ...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
- ...wissenschaftlichen Fragestellungen aus regulatorischer Sicht Erstellung von Zulassungsdokumentationen mit Schwerpunkt auf der Qualitätsdokumentation (CMC) Regulatorisches Management (Antragstellung und Begleitung) von nationalen und internationalen EU-Zulassungsverfahren für...EmpfohlenVollzeitFestanstellung
Midas Pharma GmbH
Ingelheim am RheinVor 1 Tag - ...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, Polizeiberichte...EmpfohlenBefristete ArbeitAb 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
- ...technical lifecycle management of late-stage and commercial products, including RNA and antibody-based therapeutics. Lead the Commercial CMC Team, ensuring alignment with BioNTech’s business objectives and regulatory requirements. Drive late-stage technical transfer and...Empfohlen
- ...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
- ...performance and laboratory investigations) Participate in strategic and technical discussions within projects cross-functionally with CMC team members and external partners Evaluation and review of technical and regulatory submission documents in a timely...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
- ...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
- ...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
- ...years of clinical/industry/health authority or otherwise relevant experience, preferably in a global or at least European role. Good CMC knowledge Experience in one or more of the therapeutic fields: Oncology, CNS, Cardio-Renal Strong information searching,...Empfohlen
- ...About the job Our Team: At Sanofi, we chase the miracles of science to improve people’s lives. In the Global CMC department of R&D we develop industrial-scale production processes to bring our pipeline molecules to the patient. As part of the Microbial Platform...Empfohlen
- ...About the job Within the Synthetics platform of Sanofi’s Global CMC organization, we are offering a position for a senior scientist within the DP Design team in Frankfurt which has an interdisciplinary scientific scope covering of formulation, biopharmacy and analytics...Empfohlen
- ...Praxiserfahrung an der Schnittstelle von Projektmanagement, Datenstrukturierung, und Digitalisierung Tiefe Einblicke in globales CMC- und Portfolio Prozesse Entdecke die Wunder der Wissenschaft zum Leben, gemeinsam mit unserem kollaborativem und...EmpfohlenQuereinsteigerDuales StudiumMobiles Arbeiten
- ...Guidelines Unterstützung bei der Erstellung, Prüfung und Pflege regulatorischer Unterlagen, insbesondere qualitätsbezogener Module wie CMC-Dokumentation, Entwicklungsberichte, Herstellungsbeschreibungen, Prozessvalidierungsunterlagen und Stabilitätsdokumentation Enge...VollzeitBefristete ArbeitAb sofortFlexible Arbeitszeiten
- ...breakthroughs that could turn the impossible into possible for millions. Main Responsibilities: The Scientific Fellow, AI-Enabled CMC, is a senior individual contributor and scientific thought leader at the intersection of AI, computational science, and Chemistry,...Promotion
