Accountability ClusterMajor Activities / TasksDevelopment and Optimization of mRNA Manufacturing ProcessesDesign, plan, and execute experiments to achieve robust, scalable processes forIVT,enzymatic treatments,purificationExecution of Relevant Analytical Methods for Process EvaluationPerform and supervise analytical tests to assess process performance.HPLCUV spectroscopygel electrophoresismRNA integrity/purity assaysData Analysis and Interpretation for Process ImprovementAnalyse experimental resultsapply statistical methodsprovide recommendations to enhance process performance and product quality.Preparation of Technical DocumentationTo capture process knowledge and ensure traceability writeprotocolsstudy reportsdevelopment summariesProduct & Process RobustnessPerform product and process robustness analysis for improved mRNA/formulation CMC processesCalculation of COGS at various scalesProvide technical support in improving Facility and Process Robustness also after process transfer for GMP manufacturingCollaboration in Cross-Functional Project TeamsWork with Analytical Development, Quality, and Manufacturing teams to ensure processes are transferable and compliant with GMP requirementsSupport of Technology Transfer to GMP ManufacturingParticipate in new product development for mRNA products as part of cross-functional project teamAct as receiving party for in-licensed CMC processes and analytical methodsParticipate in transferring developed processes to manufacturing facilities, providing technical guidance and troubleshooting as neededEducational 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 solutionsAbility to document and communicate effectively in English; German language skills are a plusEducational 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 solutionsAbility to document and communicate effectively in English; German language skills are a plus
Standort
Cipla, Reutlingen