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