Senior Scientist – Process Development
Core
Develop and optimize end-to-end mRNA manufacturing processes, including DNA template generation, IVT, enzymatic processing, purification, and formulation interfaces to solve specific customer issues.
Role type
Senior Scientist – Process Development (mRNA/biologics)
Builds
Scalable mRNA manufacturing workflows and robust process characterization strategies for customer products.
Domain
Biopharmaceuticals / mRNA therapeutics / Process Engineering
Required skills
mRNA process development, DNA template generation, in vitro transcription (IVT), enzymatic processing, purification, analytical characterization, DOE, QbD, process characterization, scale-up, risk assessment, CPP/CQA relationships, troubleshooting complex technical challenges, data-driven solution development
Preferred skills
End-to-end mRNA development, IVT, capping/polyadenylation, chromatography, TFF/UF-DF, process scale-up, technology transfer, GMP manufacturing support, high-throughput automation, continuous manufacturing, process intensification, PAT, mRNA analytical techniques (HPLC/UPLC, LC-MS, CE, qPCR/ddPCR, Bioanalyzer/TapeStation, sequencing), statistical tools (JMP, Minitab, Python, R), GMP/GLP environments, regulatory documentation, method qualification, validation, technical due diligence
Technologies
DNA template generation, IVT, enzymatic processing, chromatography, TFF/UF-DF, HPLC/UPLC, LC-MS, CE, qPCR/ddPCR, Bioanalyzer, TapeStation, sequencing, JMP, Minitab, Python, R
Responsibilities
Design, develop, and optimize end-to-end mRNA manufacturing processes; Develop robust and scalable workflows to improve mRNA yield, purity, quality, and manufacturability; Apply DOE, QbD, and statistical tools to build process understanding; Collaborate with Analytical Development to characterize mRNA identity, integrity, purity, and potency; Troubleshoot process and product-quality challenges using scientific and data-driven approaches; Author technical reports, development summaries, risk assessments, SOPs, and regulatory-support documentation; Evaluate and demonstrate emerging technologies including synthetic DNA, novel purification approaches, and continuous manufacturing concepts; Support process characterization, control strategy development, and implementation of CPPs and CQAs; Collaborate with manufacturing, quality, analytical, formulation, and regulatory teams to ensure successful process transfer; Participate in deviation investigations, change controls, and root cause analyses; Support GMP documentation activities including batch records, SOPs, and validation-related documentation; Assess external technologies, vendors, CDMOs, and strategic collaboration opportunities; Present technical findings, recommendations, and development strategies to project teams and senior leadership; Mentor junior scientists and contribute to a culture of scientific excellence
Seniority
Senior, hands-on IC with mentorship responsibilities