Egészségügy, gyógyszeripar állások, munkák Németországban

• Assessing clinical evaluations as part of technical documentation assessments according to the requirements layed down in the European Medical Device Regulation (MDR)
• Preparing deficiency reports in case of non-conformities with the requirements of the MDR

• Lead and collaborate with cross-functional teams to develop AI-driven biomarker signatures for target engagement, patient stratification, and early biological activity
• Design and apply computational pathology and AI approaches across diverse tissue types, disease areas, and clinical endpoints

Lead and collaborate with cross-functional teams to generate digital biomarker signatures from complex datasets using AI/machine learning, enabling target engagement assessment, patient stratification, and early signals of biological activity....

You will begin your work with an in-depth analysis of the current state of research and lay the strategic foundation for the project by comprehensively researching and evaluating diverse assay technologies, from innovative recognition molecules to advanced coupling and detection strategies....

With your PhD thesis you bring life into technology by developing automated isolation, enrichment and library preparation techniques from diverse clinical specimens which are relevant for Next-Generation Sequencing (NGS) analyses in the field of precision medicine....

• Own EU regulatory strategy for assigned programs from First-in-Human through pivotal development and marketing authorization.
• Serve as primary EU regulatory contact for cross-functional teams and provide clear, actionable regulatory guidance while ensuring compliance with regulatory requirements

• Drive sales of high-value capital equipment within the Enabling Technologies portfolio
• Develop and maintain strong relationships with existing and prospective customers
• Identify, qualify, and manage new business opportunities and sales leads

• Manage all aspects of multiple, large event projects from initial briefing to successful delivery and closing, including logistics and project content
• Cooperate with all teams assigned to an event and ensure adherence to the client's operational standards, tools and processes

• Develop and implement data‑driven, multi‑channel marketing strategies for vaccine brands
• Design marketing initiatives based on market dynamics, competition, and customer insights
• Optimize the customer journey by ensuring relevant and seamless interactions across all touchpoints

• Sie stellen die Einhaltung und kontinuierliche Weiterentwicklung unseres Qualitätsmanagementsystems im Rahmen von Quality Oversight in den Plasmacentern sicher.
• Sie überwachen und optimieren Prozesse, um höchste Qualitäts- und Sicherheitsstandards für Spender und Patienten zu gewährleisten.

Performance of qualification audits in the respective national language (EN/IT/DE) in the EMEA region at plasma suppliers / service providers according to GxP and DIN ISO and evaluating the audit results...

• Unterstützung der Teamleitung bei der Sicherstellung von GMP Compliance
• Unterstützung bei Erstellung, Überarbeitung und Verwaltung von Qualitätsvereinbarungen einschließlich Spezifikationen für die Herstellung von Plasma zur Fraktionierung

QUALITÄTSMANAGEMENTBEAUFTRAGTER (M/W/X) STANDORT: HAMBURG | VOLLZEIT | UNBEFRISTET IHRE MISSION: QUALITÄT SICHERN, ZUKUNFT GESTALTEN! Sie möchten aktiv dazu beitragen, dass unsere Plasmacenter höchste Qualitätsstandards erfüllen und sich stetig weiterentwickeln? Sie begeistern sich für die...

• You will assume overall responsibility for marketing and product management for the Sterile Technology product segment
• You will be responsible for the elaboration of strategic goals, the definition of operational goals and the management of implementation

• Manage and maintain Safety Data Sheets (SDS)
• Support regulatory documentation and compliance activities
• Maintain internal databases and digital systems
• Help improve workflows and data quality
• Collaborate with international teams on sustainability and compliance topics

• Own, structure, and continuously refine the product backlog with clear priorities aligned to product strategy
• Define user stories, acceptance criteria, and product requirements based on clinical workflows and user needs

• Design and integrate mechatronic systems for complex medical products
• Define and implement technical requirements and specifications
• Develop safe, reliable concepts for mechanical, mechatronics and system integration
• Create 3D models, engineering drawings, and technical documentation

• Designing and developing molecular probes, including the linker components.
• Collaborating with cell biologists, engineers and application experts to define probe requirements and performance specifications.

• Plan and perform GMP/GDP Audits at Contract Manufacturing Organizations (CMOs) or Suppliers
• Prepare audit findings & reports and discuss potential impact on business

• Lead quality oversight activities at CMOs to ensure compliance with Daiichi Sankyo standards and international GMP guidelines
• Support and manage quality topics such as change control, deviations, and complaints related to Daiichi Sankyo products