Senior Scientist- mRNA Technology & Process Development

Senior Scientist

Avantor is seeking a highly skilled and motivated Senior Scientist to lead and support process development initiatives and manufacturing operations for excipients and reagents.

• Ph.D. in Molecular Biology, Biochemistry, Bioengineering, Chemical/Biochemical Engineering, Pharmaceutical Sciences, Biotechnology, or a related field (required).

• Minimum of 5+ years of relevant industry experience in mRNA, RNA, nucleic acid, biologics, or pharmaceutical process development. Doctoral or relevant academic experience may be considered equivalent to industry experience.

• Strong understanding of mRNA process development, including DNA template generation, in vitro transcription (IVT), enzymatic processing, purification, and analytical characterization.

• Hands-on experience with nucleic acid process development, molecular biology techniques, and scalable manufacturing processes.

• Knowledge of process development principles including DOE, QbD, process characterization, scale-up, risk assessment, and CPP/CQA relationships.

• Experience troubleshooting complex technical challenges, interpreting multidisciplinary data, and developing data-driven solutions.

• Excellent technical writing, presentation, project leadership, and cross-functional communication skills.

• End-to-end mRNA development experience from DNA template preparation through purified mRNA and formulation interface.

• Experience with IVT, capping/polyadenylation, chromatography, TFF/UF-DF, process scale-up, technology transfer, or GMP manufacturing support.

• Familiarity with high-throughput automation, continuous manufacturing, process intensification, PAT, or advanced manufacturing technologies.

• Experience with mRNA analytical techniques such as HPLC/UPLC, LC-MS, CE, qPCR/ddPCR, Bioanalyzer/Tape Station, sequencing, or impurity analysis.

• Experience applying DOE, QbD, JMP, Minitab, Python, R, or related statistical and data-analysis tools.

• Exposure to GMP/GLP environments, regulatory documentation, method qualification, validation, or technology transfer activities.

• Experience evaluating emerging technologies, vendors, CDMOs, external collaborations, or technical due diligence opportunities.

Process Development

• Design, develop, and optimize end-to-end mRNA manufacturing processes, including DNA template generation, IVT, enzymatic processing, purification, buffer exchange, and formulation interfaces.

• Develop robust and scalable workflows to improve mRNA yield, purity, quality, process robustness, and manufacturability.

• Apply DOE, QbD, risk assessment, and statistical tools to build process understanding and establish relationships between process parameters and product quality attributes.

• Collaborate with Analytical Development to characterize mRNA identity, integrity, purity, potency-related attributes, and process impurities.

• Troubleshoot process and product-quality challenges using scientific and data-driven approaches, including root cause analysis and risk mitigation.

• Author technical reports, development summaries, risk assessments, SOPs, study protocols, and regulatory-support documentation.

• Evaluate and demonstrate emerging technologies including synthetic DNA, novel purification approaches, automation, process intensification, and continuous manufacturing concepts.

Development Support

• Support process characterization, control strategy development, and implementation of CPPs, CQAs, in-process controls, and process monitoring strategies.

• Collaborate with manufacturing, quality, analytical, formulation, and regulatory teams to ensure successful process transfer and commercial readiness.

• Participate in deviation investigations, change controls, root cause analyses, and continuous improvement initiatives.

• Support GMP documentation activities including batch records, SOPs, process transfer packages, and validation-related documentation.

• Assess external technologies, vendors, CDMOs, and strategic collaboration opportunities through proof-of-concept studies, technical due diligence, and workflow integration assessments.

• Present technical findings, recommendations, and development…