Scientist, Process Development

The Role:

We are seeking a highly skilled mRNA Scientist to join our process development team at ElevateBio. The ideal candidate will have extensive hands-on experience in mRNA synthesis, purification, and characterization. As an mRNA Scientist, you will be responsible for designing, executing, and optimizing experiments related to mRNA production and purification. You will work closely with cross-functional teams to support the tech transfer of mRNA-based therapeutics. Your contributions will be critical in advancing the manufacturing of mRNA-based products here at ElevateBio.

Here’s What You’ll Do:

• Lead the development, optimization, and scale-up experiments for mRNA based processes to achieve desired yields and purity
• Characterize mRNA samples using analytical techniques such as electrophoresis, spectrophotometry, and HPLC/UPLC to ensure product quality and consistency
• Work closely with cross-functional teams, including MSAT, analytical development, and external clients, to support project goals.
• Support the business development team in creating SOWs and proposals for external clients looking to partner for mRNA therapeutics
• Communicate experimental results and progress to internal stakeholders and external clients.
• Contribute to the development of standard operating procedures (SOPs) and technical documents.

Requirements: 

Education Requirements

• 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

Experience Requirements

• Comprehensive mRNA processing experience with hands-on experience in in-vitro transcription (IVT) and plasmid DNA linearization.
• Knowledge in mRNA downstream methods for Tangential Flow Filtration (TFF) and multiple 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 the production of mRNA drug substance
• Expertise in process scaling around mRNA production from bench scale to GMP manufacturing

Preferred Qualifications

• Experience with mRNA-LNP formulation and mixing technologies/equipment
• Ability to use statistical software such as JMP for Design of Experiments (DoE) and data analysis.
• Familiarity with GMP regulations, Quality by Design principles, and preparing regulatory filing documentation.

The budgeted range for this position is $105,000 - $145,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.