Research Scientist - mRNA Process Development
Research Scientist - mRNA Process Development
Development and Optimization of mRNA Manufacturing Processes
- Design, plan, and execute experiments to achieve robust, scalable processes for
- IVT,
- purification
Execution of Relevant Analytical Methods for Process Evaluation
- Perform and supervise analytical tests to assess process performance.
- HPLC
- gel electrophoresis
- mRNA integrity/purity assays
Data Analysis and Interpretation for Process Improvement
- 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
Master’s or PhD in Biochemistry, Molecular Biology, Biotechnology, Chemical Engineering, or related field.
- 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
Master’s or PhD in Biochemistry, Molecular Biology, Biotechnology, Chemical Engineering, or related field.
- 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
Seniority level
Seniority level
Associate
Employment type
Employment type
Full-time
Job function
Job function
Research Industries
Pharmaceutical Manufacturing
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