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.

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