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Lead Protein Purification Expert for Commercialization

vor 2 Monaten


Aachen, Nordrhein-Westfalen, Deutschland LenioBio GmbH Vollzeit

LenioBio GmbH is a dynamic and innovative biotechnology company dedicated to revolutionizing protein production through its groundbreaking ALiCE technology. We are seeking a highly experienced Late-Stage CMC Protein Purification Expert to lead the development and commercialization of our protein production platform.

As a key member of our team, you will play a pivotal role in scaling up our protein production processes, ensuring seamless technology transfer to clients and contract development and manufacturing organizations (CDMOs), and supporting regulatory submissions for our ALiCE platform.

Your Responsibilities
  • Lead the development of a scaled-up protein production platform for the application of our ALiCE technology.
  • Collaborate with CDMOs to lead process and method technology transfers, ensuring successful implementation and adherence to regulatory standards.
  • Develop comprehensive documentation for regulatory submissions to FDA/EMA/MHRA, demonstrating the safety, efficacy, and quality of our protein production processes.
  • Proactively troubleshoot processes, identifying root causes of deviations and implementing corrective actions to maintain process integrity.
  • Create and review GMP and non-GMP technical documentation, including batch records, SOPs, protocols, and reports, ensuring accuracy and compliance.
  • Serve as a key scientific liaison with Quality Control (QC), supporting the development and qualification of analytical methods for protein release and stability testing.
  • Contribute to late-phase development strategies to support potential commercialization of our ALiCE platform.
Your Profile

We are seeking a highly motivated and experienced individual with a strong background in protein purification and biopharmaceutical manufacturing.

  • Proven expertise in developing and scaling up protein purification processes, ideally within a GMP environment.
  • Extensive knowledge of regulatory requirements for biologics development and manufacturing (FDA/EMA/MHRA).
  • Strong analytical and problem-solving skills with a focus on process optimization and troubleshooting.
  • Excellent communication and collaboration skills, with the ability to effectively interact with cross-functional teams.

If you are passionate about advancing protein engineering and contributing to the development of innovative biopharmaceutical solutions, we encourage you to apply.