Senior Scientist - Downstream Process Development, mRNA
Core
Lead and support the development, optimization, and process characterization of manufacturing processes for mRNA-based therapeutics and vaccines, spanning early-phase clinical through commercial programs.
Role type
Senior Scientist, Downstream Process Development (mRNA)
Builds
mRNA-based therapeutics and vaccines for pharma/biotech clients
Domain
Biopharmaceuticals / mRNA therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
in vitro transcription (IVT) optimization, enzymatic processing, purification workflows, scale-down modeling, Design of Experiments (DOE), Quality by Design (QbD), process validation, cGMP environment experience, aseptic technique, SOP development, technology transfer, chromatography and filtration at process scale
Preferred skills
monoclonal antibody downstream development, method validation/qualification strategy, mentoring junior staff
Technologies
chromatography workstations, process skids, tangential flow filtration, normal flow filtration, viral clearance validation tools
Responsibilities
Design and optimize IVT reactions, enzymatic processing, and purification workflows; Develop scale-down models and execute DOE studies; Author process development reports, validation protocols, and risk assessments; Define control strategy for mRNA DS (CPPs, CQAs, IPCs, acceptance criteria); Ensure compliance with FDA, EMA, and ICH guidelines; Establish and maintain SOPs for mRNA synthesis and purification; Participate in tech transfer activities to GMP manufacturing sites
Seniority
Senior, hands-on IC with mentorship responsibilities
