Scientist Manufacturing-Linker-Payload-Chemistry (m/f/d)

Your Profile:

• Master's degree or preferably PhD in organic chemistry or similar with at least 5 years of relevant professional experience in an international and highly regulated environment
  
• Deep expertise in chemical manufacturing processes & chemical process development for Active Pharmaceutical Ingredients (API) (small molecules, lipids or linker-payloads); experience in process validation is considered a plus
  
• Sound knowledge in analytical technologies for chemical entities
  
• Knowledge of EU / US GMP guidelines and regulatory standards
  
• Experience with generation of regulatory documents and regulatory filings (IND/IMPD, BLA/MAA)
  
• Refined colloquial and correspondence skills in English; presentation skills adaptable to all levels of internal and external stakeholders

Your Tasks:

• Responsible for adapting, optimizing, and implementing manufacturing processes to ensure efficient and high-quality production according to the processes owned by 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) project documentation, including investigation reports, deviations, change controls, risk analysis, and qualification/validation reports according to regulatory guidelines
  
• Drive continuous improvement of linker-payload manufacturing and Lipid related processes as well as data quality, through optimizing technologies, automation, and digitalization.
  
• Contribute to implementation and monitoring of KPIs and effective process risk management to ensure process performance, stability and effectiveness of improvement measures

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