Senior CMC Manager
Vor 5 Tagen
The Senior CMC Manager will play a key leadership role in defining and delivering CMC strategy across the company's gene therapy pipeline. You will oversee internal and external activities spanning process development, GMP manufacturing, analytical development, and regulatory documentation. This position requires strong technical depth, exceptional cross-functional collaboration, and the ability to drive complex programmes toward clinical milestones.Key ResponsibilitiesLead the end-to-end CMC strategy for AAV gene therapy programmes from research handover through Phase I/II clinical studies.Manage CDMOs for both drug substance (AAV vector manufacturing) and drug product (fill-finish), ensuring adherence to timelines, budgets, and quality expectations.Oversee process development activities, including upstream/downstream optimisation (HEK293 or suspension-based systems), scale-up, and tech transfer to GMP facilities.Drive analytical method development and qualification, including potency assays, qPCR/ddPCR, capsid ratio assessments, and impurity profiling.Own CMC sections for regulatory submissions (IMPD/IND), ensuring documentation meets global regulatory standards (EMA, MHRA, FDA).Lead cross-functional CMC meetings and represent CMC in programme governance discussions.Develop and maintain project plans, critical path analyses, risk registers, and mitigation strategies.Support quality initiatives, including deviation review, comparability assessments, and lifecycle management.Contribute to long-term CMC strategy, capacity planning, and vendor selection for clinical and future commercial supply.
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Senior CMC Manager
Vor 7 Tagen
Munich, Bayern, Deutschland Barrington James VollzeitThe Senior CMC Manager will play a key leadership role in defining and delivering CMC strategy across the company's gene therapy pipeline. You will oversee internal and external activities spanning process development, GMP manufacturing, analytical development, and regulatory documentation. This position requires strong technical depth, exceptional...
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Regulatory CMC Specialist
vor 1 Woche
Munich, Deutschland S3 Science Recruitment VollzeitRegulatory CMC Manager / Senior ManagerLocation: Munich (On-site, full-time, permanent)Overview We are seeking a Regulatory CMC professional with hands-on experience authoring and leading CMC regulatory submissions across early and late stage development. This role is central in ensuring CMC strategy, documentation, and communication align with global...
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Regulatory Affairs Cmc
vor 1 Woche
Munich, Deutschland Stirling Q&R Ltd Vollzeit**Position: Regulatory Affairs CMC** **About the Company**: A renowned pharmaceutical consulting firm is currently seeking a Regulatory Affairs CMC expert with a strong background in **small molecules** and pharmaceuticals. This role offers the opportunity to provide expert guidance on regulatory strategies for drug development projects, ensuring adherence...
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Regulatory affairs
vor 1 Woche
Munich, Deutschland S3 Science Recruitment VollzeitRegulatory Affairs Specialist – CMCLocation: Germany (Hybrid / On-Site)Employment Type: PermanentOverviewWe are seeking an experienced Regulatory Affairs Specialist with strong CMC expertise to join our growing team. This role is ideal for someone with a rigorous scientific background (Master’s or PhD required) and hands-on experience supporting...
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Regulatory Cmc Lead
Vor 3 Tagen
Munich, Deutschland Stirling Q&R Ltd Vollzeit**Tasks & Responsibilities**: - Provide strategic advice to clients on quality aspects of drug development and regulatory requirements, collaborating closely with cross-functional experts within the team. - Ensure that the content of CMC work-packages and documentation align with the appropriate development phase, meet regulatory expectations, and...
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Senior Manager
Vor 7 Tagen
Munich, Bayern, Deutschland Daiichi Sankyo Europe GmbH VollzeitEngagiert in der Forschung. Im Einsatz für Patient*innen.Mit über 120 Jahren Erfahrung und rund Mitarbeitenden in mehr als 30 Ländern/Regionen setzt sich Daiichi Sankyo dafür ein, neue Pflegestandards zu entdecken, zu entwickeln und bereitzustellen, die die Lebensqualität weltweit bereichern.In Europa konzentrieren wir uns auf zwei Bereiche: Das Ziel...
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Senior Project Manager CMC
vor 1 Woche
Munich, Bayern, Deutschland Vality One Recruitment GmbH VollzeitDein AufgabengebietLeitung von bereichsübergreifenden CMC-Projekten inklusive Verantwortung für sämtliche Themen rund um Herstellung, IMPs und technische Transfers.Führung und Koordination eines interdisziplinären Expertenteams (u. a. QA, QC, Produktion, Regulatory Affairs, Supply Chain, Finanzen) sowie Sicherstellung eines reibungslosen...
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Manager QA/RA – Pharma CMC
Vor 2 Tagen
Munich, Bayern, Deutschland VERTANICAL VollzeitDu bist ein Organisationstalent mit wissenschaftlichem Scharfsinn und einem Blick fürs Detail?Bei uns hast Du die Chance, Deine Expertise in Chemie, Pharmazie oder den Naturwissenschaften in einer Schlüsselrolle einzubringen – und aktiv dazu beizutragen, bahnbrechende Therapien gegen chronische Schmerzen auf den Markt zu bringen.Als Manger QA/RA –...
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Project Lead Cmc
vor 1 Woche
Munich, Deutschland Progressive Recruitment NL VollzeitAs part of the CMC organization, the Project Lead CMC Biopharma (w/m/d) will play a central role in coordinating analytical method transfers across the companys global supplier and partner network, continuously drive life cycle management activities and contribute to the strategic project planning of QC-related activities. **Responsibilities**: -...
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drug product manager
vor 2 Wochen
Munich, Deutschland Discover International VollzeitConsultant Technology Management Drug Product TasksAdvise teams for Site-Launch activities for internal and external sites (incl. lab units, SC, RACMC and QA)Communicate with internal and external sites as part of the projectReview technical documentation (protocols, reports) associated with manufacturing, tech transfer, site-to-site transfers and PPQ as...
