Duties:
Manage database and serve as primary liaison for mRNA requests across Prime's research and program teams. Responsible for independently executing mRNA production at various scales; from high-throughput plate-based scale for screening using automation, to lab scale, to production of clinically-representative GLP toxicology batches, and serve as Person in Plant for GMP manufacturing to provide technical oversight. Contribute to both guide RNA production at various sites and scales (research, process scale and GMP) as needed. Collaborate with Analytical and QC teams to align testing and release workflows, ensuring efficient material readiness. Track and communicate batch status, material availability, and testing timelines to stakeholders. Execute critical experiments and batch runs to generate IND/BLA supporting data for liver-targeted and partnered programs. Conduct statistical and advanced analytics analyses of experimental data for process and product knowledge, producing graphs for CMC technical reports and IND/BLA filings. Plan and execute implementation of process improvements and cost-saving initiatives, including raw material evaluation. Perform in vitro transcription (IVT), capping, and purification operations, including AKTA-based chromatography. Design and support the development of analytical methods. Apply DOE principles to optimize reaction conditions and interpret experimental outcomes using advanced analytics. Operate automated systems for plate-based mRNA production and sample processing (e.g., Lynx, Big Tuna, ResolveX, Tecan, and Hamilton). Train peers on automated platforms and contribute to expanding throughput capabilities across Prime's teams.
Requirements:
Bachelor's Degree in Biochemistry, Chemistry, Chemical Engineering, Biomedical Engineering, or related field or foreign degree equivalent and 5 years of experience working on drug substance process development. Required Skills: 2 years of experience with analytical assay development. 4 years of experience with process development of enzymatic reactions for mRNA production, specifically with the use of statistical design of experiments (DoE) and analysis. 5 years of experience in downstream processing with special emphasis on chromatography of biologics and RNA (using AKTA or similar, as well as scaled down, automated systems). 1 year of experience with the synthesis and purification of long guide oligonucleotide RNA molecules. 3 years of experience with high throughput/automation development, programming, and execution (including Tecan, Hamilton, Lynx, or similar). 4 years of experience utilizing analytical characterization techniques, such as: HPLC/UPLC, TEM, DSC, UV-Vis, fluorescence spectrophotometry, and plate-based ELISA assays to support process development. 5 years of experience capturing, documenting, and maintaining records of research findings, experimental planning, progress and results in a technically-accurate, scientifically-integral and understandable manner. 2 years of experience with the Generation of manufacturing batch documents, and analytical methods development SOPs, and preparation of technical reports for IND/CTA submissions.
Salary: $103,500/year - $115,000/year
Resumes to: Human Resources, HR@primemedicine.com.