Senior Scientist
$107,500–$173,075 year
On-siteBridgewater, New Jersey, United States
Job Summary
Design and optimize end-to-end mRNA manufacturing processes, including DNA template generation, in vitro transcription, enzymatic processing, purification, and formulation interfaces. Develop robust, scalable workflows to improve yield, purity, and process robustness while applying design of experiments, quality by design, and risk assessment to establish parameter-to-quality relationships. Collaborate with cross-functional teams to characterize mRNA attributes, support GMP documentation, and execute process transfers. Troubleshoot technical challenges using data-driven approaches and evaluate emerging technologies, vendors, and continuous manufacturing concepts. Author technical reports, SOPs, and regulatory documentation while mentoring junior scientists.
Required Qualifications
- Ph.D. in Molecular Biology, Biochemistry, Bioengineering, Chemical/Biochemical Engineering, Pharmaceutical Sciences, Biotechnology, or a related field
- Minimum of 5+ years of relevant industry experience in mRNA, RNA, nucleic acid, biologics, or pharmaceutical process development
- Doctoral or relevant academic 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
Desired Qualifications
- 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/TapeStation, 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
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