Senior Scientist, Late-stage CMC Downstream Technical Development Expert
vor 2 Monaten
We'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 Purification expert to lead technology transfer activities to clients/CDMOs and support regulatory filings. As a key member of our team, you'll be responsible for Late-Stage CMC activities for our protein production platform ALiCE.
Key Responsibilities- Develop 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 support 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
- 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
- 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 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 an ability to present to a variety of stakeholders and tailor message accordingly
- Ability to adapt to dynamic situations and continuously seek to develop new skills
- Full-time, permanent position located in Aachen
- Opportunity to join an international, innovative, and fast-growing biotech company with excellent career development opportunities
- Competitive salary
- High level of freedom and responsibility
- Diverse and international team of dedicated, open-minded colleagues
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