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Senior/Principal Scientist, Late-stage CMC Downstream Technical Development Expert
vor 1 Monat
LenioBio GmbH is 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 scaling our protein production platform, ALiCE, to meet the evolving needs of the biopharmaceutical industry.
Key Responsibilities- Develop and execute a scaled-up protein production platform for ALiCE
- 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
- Create 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 closely with colleagues to ensure a seamless TechOps team
- 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
At LenioBio, we're pioneers on a mission to revolutionize protein production, enabling faster, more efficient drug discovery and manufacturing. Our groundbreaking ALiCE technology is redefining the boundaries of what's possible in protein engineering. Join us and be part of a collaborative and forward-thinking environment where your contributions are valued, and your growth is supported.
