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

vor 3 Monaten

Aachen, Deutschland LenioBio GmbH Vollzeit
Job description

At LenioBio, we believe every person should have the opportunity to live a healthy and productive life. And how do we do this? We develop robust, efficient and sustainable technologies to disrupt the way medicines are produced for those in need, wherever they are.  
 
We are in the midst of an incredible journey, and we are looking for passionate individuals to join us on this important mission. Do you want to be part of our journey? Then please keep reading 

At LenioBio GmbH, everything we do begins with our mission: to provide our customers with disruptive solutions to address their challenges easier, quicker, cheaper, better, and safer. 
Our ALiCE technology scales with the pharmaceutical R&D process, from discovery to clinical trials/product testing and finally, to GMP-grade production, in the form of an end-to-end integrated production platform.  
LenioBio aims to unlock the full potential of ALiCE® and will enable protein drugs to be brought to the market faster and at a lower cost.

About this job

For our path on the commercialization of the ALiCE protein production platform, we seek an experienced Late-Stage CMC Protein Purification expert with demonstrated Leadership ability for scale-up and process development of the protein production platform, to lead technology transfer activities to clients/CDMOs and to support regulatory filings.

Your responsibilities

You will be responsible for Late-Stage CMC activities for our protein production platform ALiCE. This includes: 

  • Lead Development of a scaled-up Protein Production Platform for the application of our ALiCE technology
  • Collaborate with CDMOs to lead through Process & Method Tech Transfers
  • Create and overall support for regulatory submissions 
  • Troubleshoot processes to identify root causes, propose corrective actions, and support resolution of deviations
  • Create and review GMP and non-GMP technical documentation (batch records, SOPs, protocols, and reports)
  • Act as Key Scientific Liaison to QC and support the development and qualification of analytical methods used for the release and stability testing
  • Contribute to late-phase development strategy to support potential commercialization
  • Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team
  • Provide technical support, training, and SME knowledge to assist with the development of junior associates. Expand the technical capabilities of the Process Development group by offering expertise in areas such as technology development, platform, or systems development
We are looking for people that want to bring in their best, learn from the best, and create the best. That does not mean you scored 180 on an IQ test. It means that you are an expert in your craft because you love what you do, you know you can become even better, and you are constantly looking for the boundary of the possible.Requirements

This job will suit you best if you 

  • have 6+ years’ industry experience in biologics downstream process development 
  • have a M.Sc. in Biochemical/Bioprocess engineering or similar
  • worked in late-stage biologics programs, including process characterization studies, process validation, and risk management (e.g. FMEA)
  • have GMP manufacturing experience (as a plus)
  • are an expert in scaling purification processes for the production of therapeutic proteins
  • have supported the writing of regulatory submissions to FDA/EMA/MHRA etc
  • have demonstrated Leadership ability to create and execute functional plans and lead through influence cross functionally 
  • have excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
  • are always committed and energized when faced with ambiguity and changes. You should be able to quickly adapt to dynamic situations, continuously seeking to develop new skills and stretch yourself beyond comfort zone
  • like to work in a cross-functional team and are fluent in English
What we offer

  • full-time, permanent position located in Aachen
  • opportunity to join an international, innovative, and fast-growing biotech company, with excellent career development opportunities, where you can develop yourself professionally and have a real impact in the company AND in science from day one
  • competitive salary 
  • high level of freedom and responsibility
  • a great diverse and international team of dedicated, open-minded colleagues 
About us

At LenioBio, we're not just a biotechnology company—we're pioneers on a mission to revolutionize how complex proteins are produced, enabling faster, more efficient drug discovery and manufacturing. Our groundbreaking ALiCE technology is redefining the boundaries of what’s possible in protein engineering, enabling the rapid, scalable, and efficient production of complex proteins that are at the forefront of medical innovation. Divided between our headquarters Düsseldorf, Germany, with our innovation hub in Aachen, we’re a dynamic and innovative team committed to pushing the boundaries of science and making a tangible impact on healthcare. 

 

As we continue to grow, we’re focused on expanding ALiCE’s capabilities to meet the evolving needs of the biopharmaceutical industry. 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. Join us and be a part of something truly groundbreaking. 

 

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