Senior/Principal Scientist, Late-stage CMC Downstream Technical Development Expert

vor 4 Wochen


Aachen, Nordrhein-Westfalen, Deutschland LenioBio GmbH Vollzeit
About this role

We are seeking an experienced Senior/Principal Scientist to lead our Late-stage CMC Downstream Technical Development efforts. As a key member of our team, you will be responsible for developing and implementing scalable protein production platforms using our innovative ALiCE technology.

Key responsibilities
  • Develop and execute process development strategies for Late-stage CMC activities
  • Collaborate with CDMOs to lead process and method technology transfers
  • Create and support regulatory submissions
  • Troubleshoot processes to identify root causes and propose corrective actions
  • Develop and review GMP and non-GMP technical documentation
  • Act as a key scientific liaison to QC and support the development and qualification of analytical methods
  • Contribute to late-phase development strategy to support commercialization
  • Collaborate with colleagues to ensure a seamless TechOps team
Requirements

To be successful in this role, you will need:

  • 6+ years' industry experience in biologics downstream process development
  • M.Sc. in Biochemical/Bioprocess engineering or similar
  • Experience in late-stage biologics programs, including process characterization studies, process validation, and risk management
  • GMP manufacturing experience (a plus)
  • Expertise in scaling purification processes for therapeutic proteins
  • Experience in supporting regulatory submissions to FDA/EMA/MHRA
  • Demonstrated leadership ability to create and execute functional plans and lead through influence cross-functionally
  • Excellent communication skills with the ability to present to various stakeholders
About us

At LenioBio GmbH, we're pioneers in protein production, enabling faster, more efficient drug discovery and manufacturing. Our ALiCE technology is redefining the boundaries of what's possible in protein engineering. We're a dynamic and innovative team committed to pushing the boundaries of science and making a tangible impact on healthcare.

We're looking for passionate, talented individuals to join us on this exciting journey. At LenioBio, you'll be part of a collaborative and forward-thinking environment where your contributions are valued, and your growth is supported.



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