The Scientist/Senior Scientist, Nucleic Acids is responsible for driving results in a fast-paced environment by leading the scale-up activities and refining the process.
• Responsible for process research and development of various mRNAs.
o Evaluation of enzymes, plasmids and reagents to achieve required quality attributes of mRNA.
o Evaluation of process steps and parameters in IVT, capping and purification of mRNA to achieve higher yield and purity.
o Process research of novel approaches to produce mRNA
• Scale up mRNA production process from milligrams scale to grams scale and eventually to 100+ g scale.
• Set up GMP system for production of mRNA under development phase – appropriate cGMP.
• Manufacture GMP batches for toxicology and clinical studies as necessary.
• Perform mRNA testing as needed during process development and scale up.
• Work closely with Formulation, LNPs process R&D, analytical R&D, quality and regulatory teams.
• BS/MS with 6 to 8 years relevant experience (PhD with 2 to 5 years preferred) in making purifying and analyzing oligonucleotides, mRNAs at bench and larger scales.
• Strong foundation in biochemistry, molecular biology, or related field.
• Familiarity with cGMP requirement for early development is a plus.
• Must be comfortable in a fast-paced small company environment with minimal direction.
• Flexible, adapt to change, and work independently and as part of a multi-disciplinary team.
• Self-starter with excellent interpersonal skills with demonstrated success in working collaboratively cross functionally in a matrix environment.
• Multi-task, pay attention to details and produce high quality work under tight timelines.
• Strong oral and written communication skills to support internal and external communications/presentations.
• Prior experience leading teams preferred.