HOW YOU’LL FLY
As a Scientist I bird reporting to Scientist II, you'll help to bring more patients their bluebird days by:
- Subject matter expert for large scale purification of nucleic acids and industry landscape of mRNA therapeutics and manufacturing.
- Downstream process improvement and scale up of mRNA, including chromatography separations and filtrations.
- Evaluating and developing novel purification techniques for high-quality mRNA (lab execution and vendor management).
- Supporting technology transfer to manufacturing by assisting with development reports, reviewing batch records, and providing technical support.
- Writing and reviewing development reports, technical supporting documents, change controls, and CMC sections for regulatory filings.
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- BS with 10+ years, MS with 8+ years, or Ph.D with 0+ years of relevant industry experience. Degree emphasis in Chemical Engineering, Bioengineering, Chemistry, Molecular Biology or related field preferred.
- This position requires conducting laboratory experiments, excellent documentation review and writing skills, and the flexibility to work on multiple projects as needed.
- Understanding of nucleic acid chemistry, enzymatic and chemical reactions, and purification techniques for macromolecules.
- Hands-on experience with a wide range of purification techniques for large nucleic acid molecules (affinity chromatography, anion exchange, hydrophobic interaction, etc.)
- Hands-on experience with a wide range of filtration techniques for large nucleic acid molecules (Depth filtration, UF/DF, TFF, etc.)
- Experience with downstream process optimization and scale-up using design of experiment (DoE).
- Working knowledge of ÄKTA systems and UNICORN control software, proficiency strongly preferred.
- Track record of completing deliverables within specified timelines.
- Knowledge of relevant USP/ICH/EU regulations, GMP/GLP requirements, and industry practices.
- Ability to execute, document and follow-through, projects to completion.