Protein Production Platform Lead, Late-stage CMC Downstream Technical Development
vor 2 Wochen
We are a biotechnology company pioneering the development of robust, efficient, and sustainable technologies to disrupt the way medicines are produced. Our mission is to provide our customers with innovative solutions to address their challenges easier, quicker, cheaper, better, and safer.
Job DescriptionWe are seeking an experienced Late-Stage CMC Protein Purification expert to lead technology transfer activities to clients/CDMOs and to support regulatory filings. The successful candidate will be responsible for Late-Stage CMC activities for our protein production platform ALiCE, including:
- Leading the development of a scaled-up Protein Production Platform for the application of our ALiCE technology
- Collaborating with Contract Development and Manufacturing Organizations (CDMOs) to lead through Process & Method Tech Transfers
- Creating and supporting regulatory submissions
- Troubleshooting processes to identify root causes, propose corrective actions, and support resolution of deviations
- Creating and reviewing Good Manufacturing Practice (GMP) and non-GMP technical documentation (batch records, Standard Operating Procedures (SOPs), protocols, and reports)
- Acting as a Key Scientific Liaison to Quality Control (QC) and supporting the development and qualification of analytical methods used for the release and stability testing
- Contributing to late-phase development strategy to support potential commercialization
- Collaborating closely with colleagues to ensure a seamless, highly integrated Technical Operations (TechOps) team
- Providing technical support, training, and Subject Matter Expert (SME) knowledge to assist with the development of junior associates
The ideal candidate will have:
- 6+ years' industry experience in biologics downstream process development
- A Master's degree in Biochemical/Bioprocess engineering or similar
- Experience in late-stage biologics programs, including process characterization studies, process validation, and risk management (e.g. Failure Mode and Effects Analysis (FMEA))
- GMP manufacturing experience (a plus)
- Expertise in scaling purification processes for the production of therapeutic proteins
- Experience in supporting the writing of regulatory submissions to FDA/EMA/MHRA, etc.
- Demonstrated Leadership ability to create and execute functional plans and lead through influence cross-functionally
- Excellent communication skills with the ability to present to a variety of stakeholders and tailor message accordingly
- Commitment to continuous learning and professional development
- A full-time, permanent position located in Aachen
- The opportunity to join an international, innovative, and fast-growing biotech company with excellent career development opportunities
- A competitive salary
- A high level of freedom and responsibility
- A diverse and international team of dedicated, open-minded colleagues
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Aachen, Nordrhein-Westfalen, Deutschland LenioBio GmbH VollzeitAbout LenioBio GmbHWe're a pioneering biotechnology company on a mission to revolutionize protein production, enabling faster and more efficient drug discovery and manufacturing. Our groundbreaking ALiCE technology is redefining the boundaries of what's possible in protein engineering.Job OverviewWe're seeking an experienced Late-Stage CMC Protein...
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