Scientist, Process Development
$105,000–$145,000 year
On-siteWaltham, Massachusetts, United States
Job Summary
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 and tech transfer of mRNA-based therapeutics. Support the business development team in creating SOWs and proposals for external clients. Communicate experimental results and progress to internal stakeholders and external clients. Contribute to the development of standard operating procedures (SOPs) and technical documents.
Required Qualifications
- BS/MS in Microbiology, Bioengineering, Biochemistry, or a related discipline
- 8+ years of relevant experience
- minimum of 4 years in working with mRNA-based therapeutics
- Comprehensive mRNA processing experience
- hands-on experience in in-vitro transcription (IVT)
- hands-on experience in plasmid DNA linearization
- Knowledge in mRNA downstream methods for Tangential Flow Filtration (TFF)
- Knowledge in multiple chromatography techniques such as dT Affinity, IEX, and RP-HPLC
- Experience operating automated chromatography systems (ÄKTA Avant/Pure)
- Experience operating 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
Desired 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
- Familiarity with Quality by Design principles
- Familiarity with preparing regulatory filing documentation
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