mRNA Process Development Scientist – Scale-Up & GMP

ElevateBio; United States; On-site; USD 105,000 - 145,000; Full time

Job summary

ElevateBio in the United States is seeking an experienced mRNA Scientist to join our process development team. You will design, execute, and optimize mRNA production and purification, scaling from bench to GMP manufacturing, and support tech transfer to external clients.

You will work with MSAT, analytical development, and business development to prepare proposals, document SOPs, and communicate results to stakeholders.

Qualifications

• BS/MS in Microbiology, Bioengineering, Biochemistry, or a related discipline with 8 years of relevant experience, with a minimum of 4 years in working with mRNA-based therapeutics
• Comprehensive mRNA processing experience with hands-on IVT and plasmid DNA linearization
• Knowledge in mRNA downstream methods for TFF and chromatography techniques such as dT Affinity, IEX, and RP-HPLC
• Experience operating automated chromatography systems (ÄKTA Avant/Pure) and filtration skids (Repligen KrosFlow Kr2i)
• Comprehensive understanding of tech transfer activities around production of mRNA drug substance
• Expertise in process scaling around mRNA production from bench scale to GMP manufacturing
• Experience with mRNA-LNP formulation and mixing technologies/equipment
• Ability to use JMP for DoE and data analysis
• Familiarity with GMP regulations and regulatory filing documentation

Responsibilities

• Lead development, optimization, and scale-up experiments for mRNA processes to achieve desired yields and purity
• Characterize mRNA samples using analytical techniques (electrophoresis, spectrophotometry, HPLC/UPLC)
• Collaborate with MSAT, analytical development, and external clients to support project goals
• Support BD in creating SOWs and proposals for external clients in mRNA therapeutics
• Communicate experimental results and progress to internal and external stakeholders
• Contribute to SOPs and technical documents

Skills

mRNA processing

In vitro transcription (IVT)

Tech transfer

Process scaling

Analytical communication

Education

BS/MS in Microbiology/Bioengineering/Biochemistry or related

Tools

AKTA Avant/Pure

Repligen KrosFlow Kr2i

Tangential Flow Filtration (TFF)

HPLC/UPLC

DoE software (JMP)

Job description

ElevateBio in the United States is seeking an experienced mRNA Scientist to join our process development team. You will design, execute, and optimize mRNA production and purification, scaling from bench to GMP manufacturing, and support tech transfer to external clients.

You will work with MSAT, analytical development, and business development to prepare proposals, document SOPs, and communicate results to stakeholders.