Erhalten Sie die neuesten Jobs per E-Mail
- ...Your main responsibilities: Act as global regulatory affairs CMC lead for the assigned development and/or commercial products and/or projects and define and execute the Global Regulatory CMC strategy from pre-clinical stage up to Marketing Authorisation...Empfohlen
€ 75.000 - € 90.000
...fair wages are rare, you say? Well, today is your lucky day! Our subsidiary Randstad professional solutions has a vacant position as CMC Documentation Manager in the Rhine-Main area. Tariff-based wages, care by a company medical center, and employee discounts - all advantages...Empfohlen- ...Your contribution: ~ Plan, coordinate, integrate, execute, monitor, and close protein-based CMC oncology projects in collaboration with internal teams and external CDMOs ~ Coordinate and manage the efficient flow of content and information across interdisciplinary...Empfohlen
- ...As part of the CMC Project Management team at BioNTech, you will be responsible for supporting the Global Technical Development Leadership team, the CMC PM team leads and the project managers in their daily project-related work. Your contribution: Administrative...Empfohlen
- ...BioNTech is seeking an experienced Statistical Expert (Director Analytical Development (Statistics CMC) to support our Analytical Development team. You will develop statistical guidelines, perform analyses, and ensure compliance with global regulatory standards. Your expertise...EmpfohlenPhD
- ...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
- ...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
- ...von Schutzprüfungen in MS/HS‑Netzen inkl. Prüfung von Schutzrelais (z. B. Überstrom, Distanz, Differential) + Einsatz von OMICRON CMC‑Prüftechnik sowie Erstellung und Ausführung von Prüfsequenzen in Test Universe Inbetriebnahme von Mittel- und Hochspannungsanlagen...Empfohlen
- ...leverage Sanofi's capabilities make us the best place to push the boundaries of medicine through technology. The Digital In-Silico CMC team is an innovation engine within Digital R&D, building next-generation digital products that transform how we discover, design,...Empfohlen
- ...die Wunder der Wissenschaft, um das Leben der Menschen zu verbessern. Unser Team: In der Mikrobiellen Platform (R&D, Global CMC Development) werden Prozesse der Zukunft für biotechnologisch hergestellte Wirkstoffe entwickelt. In der GMP-Pilotanlage werden diese...Empfohlen
- ...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
- ...Alignment with different local and global stakeholder groups (e.g. legal, procurement, operational quality assurance, qualified persons, CMC) A Good Match: ~ Several years of professional experience ( ~3 years) in the pharmaceutical industry, preferably...Empfohlen
- ...Ingenieurwesen, Naturwissenschaften, Informatik oder eine vergleichbare Qualifikation bringst umfassende Erfahrung mit klinischen Studien, CMC-Projektmanagement, Scale-Up oder Tech-Transfer in der Biotech- oder Pharmaentwicklung mit hast praktische Erfahrung in der...EmpfohlenUnbefristete ArbeitWeiterbildungMobiles Arbeiten
- ...Sicherstellung der E2E Set-Up (DS, DP, FG) der klinischen Bedarfe und Phase-III, wo zutreffend (verantwortlich für den Einrichtungsprozess mit CMC, um einmal im Monat Informationen über die klinischen und Phase-III-Bedarfe zu erhalten) Definition von wichtigen Meilensteinen...EmpfohlenHybrides Arbeitsmodell
- ...internal and external analytical network. Further, you will be representing the analytical network in the interdisciplinary late-stage CMC team to advance development projects to the market. Your Contribution: Represent analytics in interdisciplinary teams...EmpfohlenPhD
- ...The (Associate) Director Protein & ADC Drug Product will be part of the CMC project team leading external development and manufacturing activities of protein-based therapeutics and antibody drug conjugates (ADCs). He/she will provide scientific and technical input...PhD
- ...initiatives. Ensure alignment with organizational goals and industry best practices Actively engage with cross-functional teams, including CMC, R&D, MS&T, AS&T, Manufacturing, and other departments, to foster collaboration and ensure seamless integration of engineering...
- ...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...VollzeitPhDHomeoffice
- ...zum Leben erwecken – alles mit der Unterstützung inspirierender Mentor*innen und kollaborativer Teams. Über uns Das globale CMC Project & Portfolio Management Office unterstützt die Steuerung, Governance und Weiterentwicklung von Projekt- und Portfoliomanagementprozessen...QuereinsteigerPflichtpraktikumMobiles Arbeiten
- ...Teams. Projektleiterfunktion für Investprojekte €: SME für alle USP relevanten Fragestellungen aus dem Lauch Unit Netzwerk und den CMC Developmentbereichen um die Standardisierung und Digitalisierung der Produktionsprozesse weiter voranzutreiben. SME für alle USP...PromotionHybrides Arbeitsmodell
- ...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...QuereinsteigerDuales StudiumMobiles Arbeiten
- ...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...PhD
- ...current operational status across all relevant stakeholders Manage key stakeholders across departments such as Commercial, CTSM, CMC, Product Teams, Regulatory Affairs (RA), Quality Assurance/Quality Control (QA/QC), and production sites to create an aligned supply...
- ...objectives while providing regular reporting to the Global Program Quality Head InsuLINK and dotted line reporting to Manager Regulatory CMC. Ensure compliance of InsuLINK insulin API products with all relevant product registrations, laws, regulations, standards, and...PhD
- ...Demand: Drive the development and implementation of category strategies in collaboration with business stakeholders, such as CMC, ESO, Supply Chain, Product Supply, MS&T and QA Identify and assess global business needs, proactively engaging with the business...
113600 - 171600 $
...primary interface between CTSM internal functions and trial teams. Serve as the point of contact for other departments (e.g., GCO, CMC, PM, GRA), attend cross-functional meetings, and ensure trial set-up requirements are followed across functions. Own and maintain...€ 130.000 - € 140.000
...initiatives. Ensure alignment with organizational goals and industry best practices. - Actively engage with cross-functional teams, including CMC, R&D, MS&T, AS&T, Manufacturing, and other departments, to foster collaboration and ensure seamless integration of engineering...Unbefristete ArbeitVollzeitAb sofortHomeofficeFlexible Arbeitszeiten- ...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...VollzeitFestanstellung
Midas Pharma GmbH
Ingelheim am RheinVor 12 Tagen
