Senior Scientist – Process Development

The Opportunity:

Under limited supervision, develop and implement solutions for customers based on our products and services through close collaboration with customers and other innovation associates/scientists. Identify and develop innovative applications for a range of products to solve specific customer issues by planning and executing hands on studies at internal and customer laboratories.

• 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.

• 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.

• 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,…