Erhalten Sie die neuesten Jobs per E-Mail
€ 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 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
- ...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
- ...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 12 Tagen - ...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
- ...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
- ...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...EmpfohlenPhD
- ...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...Empfohlen
- ...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...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
- ...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
- ...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...Empfohlen
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
