Suchergebnisse: 26 Stellenangebote
...Associate Director* GMP/CMC Drug Product
At BioNTech, you will be part of our GMP and CMC management team supporting all clinical projects with respect to product quality and CMC documentation for regulatory dossiers.
Your responsibilities in detail:...
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PhD Position
...Director* GMP/CMC Drug Product
At BioNTech, you will be part of bringing our mRNA-based individualized tumor vaccine product family to a successful registration.
Your responsibilities in detail:
Definition and execution of the CMC development strategy...
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PhD Position
...Manager Regulatory Affairs CMC Authoring
You will author global quality regulatory documents and provide input into the development of the regulatory CMC strategy for the assigned project(s) in different stages of development, including pre-clinical, Ph...
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...Associate Director* CMC Project Management
As Associate Director* in the CMC Project Management Team at BioNTech, you will be responsible in a co-leadership/tandem role with the CMC lead for cross-functional teams in a variety of development projects and late...
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...möchtest, vielen Menschen Hoffnung auf eine gesunde Zukunft zu geben, dann sollten wir uns kennenlernen!
Associate Director* CMC Project Management (mAB/ADC)
As Associate Director in the CMC Project Management Team at BioNTech, you will be responsible...
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Flexible Arbeitszeit
...Project Manager* CMC
As a Project Manager* in the CMC Project Management Team at BioNTech, you will be core-part of cross-functional project teams in a variety of CMC development/clinical stage projects focusing on our individualized cancer vaccine pipeline (IVAC...
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...Pharmaziepraktikant* im Bereich GMP/CMC Management Drug Product
ab Mai 2024 oder November 2024
Bei BioNTech leistest du einen entscheidenden Beitrag zur Bereitstellung von Prüfpräparaten zur Therapie oder Prävention von Infektionskrankheiten für unsere...
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Für Pharmaziepraktikanten
...Associate Director* CMC Management RNA
At BioNTech, you will be part of our CMC Project Management team, supporting clinical projects from early to late development stages.
Your responsibilities in detail:
Coordination of CMC operational...
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PhD Position
...Associate Director* Regulatory Affairs CMC (SmMo and mAbs projects)
Through your innovation, passion and unity with your colleagues you can become a pioneer in our Global Regulatory Affairs Team. In this position, you will lead all aspects of Global Regulatory...
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Regulatory Affairs Manager CMC (m/w/div.) - Teilzeit 25 Std./Woche
HENNIG ARZNEIMITTEL ist ein modernes und unabhängiges Pharmaunternehmen mit einer 125-jährigen Tradition und rund 300 Mitarbeitern. Zur Verstärkung unserer Regulatory Affairs CMC-Abteilung suchen wir...
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Teilzeitarbeit
...main responsibilities are:
~Collaborate with external/internal stakeholders to improve clinical trial operations.
~Coordinate with CMC on product characteristics (volume/concentration)
~Collaborate with GCP Compliance to conduct CRO training.
~Translate clinical...
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...registration activities, which including matters from e. g. Labeling (German product informative texts), Medical Affairs, Pharmacovigilance and CMC. Regulatory activities might involve cooperation with partners for outsourcing or co-developing
Regulatory submissions to and...
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...FixVac.
Your main responsibilities are:
Accountable representative of quality assurance in core teams, project management and CMC ensuring quality & compliance for clinical projects
Responsible for assessment of critical decision making impacting supply and regulatory...
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...triggering and monitoring of initiatives related to the project/product (e.g. establish COGS roadmaps and product supply strategy, define CMC team collaboration during commercial life cycle...).
Benefits:
BioNTech is committed to the wellbeing of our team members and...
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Vollzeit
...Manager* CTSM Planning & Analytics
Your main responsibilities will be:
Liaise with CMC function to translate clinical DP demand plans into a supply plan
Consolidate clinical DP demand plans across trials
Define safety stock requirements...
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...persönlichem Karriereweg und bieten Dir vielfältige Möglichkeiten, Dich weiterzuentwickeln.
Projektmanager (m/w/d) mit Schwerpunkt CMC (Chemistry, Manufacturing, and Controls)
Aufgaben:
Du bist verantwortlich für die Planung, Überwachung und Betreuung der Herstellung...
Vollzeit
Promotion
Homeoffice
Flexible Arbeitszeit
...functional teams in at least of the following areas: Biostats, Data management, Clinical Trial Supply and Logistics, IRT, Pre-clinical , CMC, Clinical Pharmacology, Translational Sciences, Medical Affairs, Commercial, Regulatory Affairs, Companion Diagnostics, etc.
Drive...
...the respective global MS&T
department
• Responsible for interfaces between internal Stakeholders (e.g. Technical Development/CMC) and Manufacturing Network Partner and manage day-to-day operations and workflows
• Create, review, and approve (external)...
PhD Position
...Establishing and Qualification of Small-Scale Models
Documentation set-up and alignment for harmonized rapid process transfers & CMC documentation
Qualifikationsprofil:
Degree in natural sciences (ideally PhD)
Sound experience in vitro RNA synthesis (therapeutic...
Vollzeit
PhD Position
...main responsibilities are:
As leading subject matter expert (SME), you are our interface to internal Stakeholders (TechDev/CMC, Regulatory Affairs, QA etc.) and external Manufacturing Network Partners.
You will drive continuous improvement, process...
