Accountability Cluster
Major Activities / Tasks
Development and Optimization of mRNA Manufacturing Processes
* Design, plan, and execute experiments to achieve robust, scalable processes for
* IVT,
* enzymatic treatments,
* purification
Execution of Relevant Analytical Methods for Process Evaluation
* Perform and supervise analytical tests to assess process performance.
* HPLC
* UV spectroscopy
* gel electrophoresis
* mRNA integrity/purity assays
Data Analysis and Interpretation for Process Improvement
* Analyse experimental results
* apply statistical methods
* provide recommendations to enhance process performance and product quality.
Preparation of Technical Documentation
* To capture process knowledge and ensure traceability write
* protocols
* study reports
* development summaries
Product & Process Robustness
* Perform product and process robustness analysis for improved mRNA/formulation CMC processes
* Calculation of COGS at various scales
* Provide technical support in improving Facility and Process Robustness also after process transfer for GMP manufacturing
Collaboration in Cross-Functional Project Teams
* Work with Analytical Development, Quality, and Manufacturing teams to ensure processes are transferable and compliant with GMP requirements
Support of Technology Transfer to GMP Manufacturing
* Participate in new product development for mRNA products as part of cross-functional project team
* Act as receiving party for in-licensed CMC processes and analytical methods
* Participate in transferring developed processes to manufacturing facilities, providing technical guidance and troubleshooting as needed
Educational qualifications:
Master’s or PhD in Biochemistry, Molecular Biology, Biotechnology, Chemical Engineering, or related field.
Relevant experience:
* 5+ years of industry experience in mRNA process development, bioprocess engineering, or mRNA manufacturing.
* Strong hands-on experience with in vitro transcription (IVT), mRNA purification techniques, and tangential flow filtration (TFF).
* Solid understanding of mRNA handling, enzymatic processing, and formulation strategies.
* Proficiency in data analysis, scientific writing, and presentation of technical findings.
* Quick learner with curiosity to challenge status quo and find innovative solutions
* Ability to document and communicate effectively in English; German language skills are a plus
Educational qualifications:
Master’s or PhD in Biochemistry, Molecular Biology, Biotechnology, Chemical Engineering, or related field.
Relevant experience:
* 5+ years of industry experience in mRNA process development, bioprocess engineering, or mRNA manufacturing.
* Strong hands-on experience with in vitro transcription (IVT), mRNA purification techniques, and tangential flow filtration (TFF).
* Solid understanding of mRNA handling, enzymatic processing, and formulation strategies.
* Proficiency in data analysis, scientific writing, and presentation of technical findings.
* Quick learner with curiosity to challenge status quo and find innovative solutions
* Ability to document and communicate effectively in English; German language skills are a plus