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Upstream Process Developer
2 weeks ago
This role involves contributing to the development of antibody products through upstream process development. You will be working with the Cell Culture team, focusing on the development of mammalian cell lines and upstream processes.
Your key responsibilities will include planning and executing experiments, documenting development work, and transferring technical knowledge to external partners. You will also collaborate with colleagues in Denmark and France, as well as partners at external Contract Manufacturing Organizations (CMOs).
The Cell Culture team operates within the Drug Substance Development department, working closely with technicians and scientists in this department.
Key Responsibilities:
- Planning and execution of experiments and processes
- Development of mammalian cell lines and upstream processes
- Documentation of development work and reports
- Technical transfer to CMO's and oversight of outsourced activities
- Maintenance of manufacturing documents and records
- Review and approval of batch documentation
- Troubleshooting and documentation of quality incidents
- Support for regulatory documentation and compliance
- Process optimization and workflow improvements
Requirements:
- A Master's degree or equivalent experience in biopharmaceuticals or a related field
- Proven experience with mammalian cell culture processes
- Excellent communication and language skills
- Self-motivated, collaborative, and results-driven individual
