Technical product designer állások Külföldön (egészségügy, gyógyszeripar)

Collaborate closely with Translational Science Leads (TSL), Clinical Operations, Biostatistics/Bioinformatics, and Data Management teams to execute translational science strategies in clinical trials....

The role combines two aspects: the Technical Support to Regions (TSR-API), which entails addressing any Regulatory Affairs and Quality Assurance needs that arise in the assigned region (EMEA), and the Technical Support to Manufacturers (TSM-API), which involves acting as the central point of...

The Division of B Cell Immunology studies the molecular and cellular mechanisms affecting the quality of immune responses to vaccination for malaria in preclinical models and humans. The work includes diverse immunological, molecular, cellular, and biochemical assays. In this role, you will plan,...

• Design and execute experiments for purification of recombinant proteins
• Analyze and interpret data to guide process development and troubleshooting
• Collaborate cross-functionally with other RnD teams
• Contribute scientifically to the project progress, lead project discussions and development

• Active contribution to Product care and a Key role in Product development as the technical lead for the Orbit & Consumables portfolio
• Technical support of product development project team

Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projects...

You will be a part of the Field Applications Specialist Team and report to the Field Application Manager responsible for providing frontline support by resolving customer(s) problems and issues through technical, scientific expertise and troubleshooting. You will help drive revenue growth while...

• Support, define, plan, document, and technically manage product development activities to ensure delivery in accordance with design objectives and development plans.
• Identify and understand user needs through engagement with key stakeholders.

Creation, editing, and review of all quality documents (DEV, CAPA, CCO, maintenance completion reports) in accordance with SOP specifications...

The Advanced Workflow Specialist â Electron Microscopy Sample Preparation (d/f/m) plays a key customer-facing role within the EMEA Business Development team. The position supports pre-sales and post-sales activities by delivering expert application knowledge, demonstrations, trainings, and workflow...

• Take full responsibility for the product portfolio throughout its entire lifecycle - from concept to phase-out
• Derive market and customer needs and translate them into clear product requirements and strategies

• Collaboration on S1 and S2 work, including work with virus-containing material after appropriate training
• Cultivation and handling of cells, including work on a larger scale up to 25L (working with various bioreactor systems)

Write, review and approve design and development documents, including design inputs, outputs, verification, validation, and design transfer activities...

• Provide guidance on regulatory and quality requirements, including MDR and FDA requirements, for our in-house and our customer software projects
• Create technical documentation for our industry projects together with our software development teams

• Become an expert in Brainlab's orthopedic planning and endovascular navigation portfolio
• Demonstrate solutions both in person and online, showcasing clinical value through interactive demos, workshops, and webinars

• Working with high throughput lab – analyzer
• Routine lab work with infectious samples and leading of own experiments including the analysis of them
• Plan and execute different work packages for the development of molecular diagnostics test

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

• Lead strategic relationships with CMOs to improve cost, quality, delivery performance and innovation (annual spend $60-70M)
• Conduct regular business reviews (SRM) and monitor KPIs, performance metrics, and contractual compliance

• Maintain and further develop our QMS in line with EN ISO 13485 and MDSAP
• Create, update, and improve procedures, forms, and training materials
• Plan and deliver training on procedures and regulatory requirements
• Lead and oversee CAPA initiation, processing, tracking, and review

Govern and steer the innovation pipeline, ensuring effective project management of all innovation initiatives in line with stage gate principles...