The Opportunity

We are currently seeking a highly motivated Scientist/Sr. Scientist to join the Analytical Operations (AMD) team of seven. In this role, you will be responsible for the analytical method development (AMD) and play a critical role in establishing the analytical methods and control strategy. You will be conducting both routine and non-routine analytical testing in support of preclinical and clinical development. The ideal candidate will have extensive experience in development of chromatographic and electrophoretic analytical methods.

Responsibilities and Duties:

• Develop analytical methods that robustly characterize our mRNA-based lipid nanoparticle (LNP) drug products
• Specifically focus on optimization and analytical characterization of protein-lipid conjugations for targeted therapeutics
• Design, execute both routine and non-routine analytical analyses
• Document analytical method development activities in support of process development, stability, and product characterization
• Follow and ensure standard operating procedures, analytical test methods, and analytical sampling plans 
• Work with internal and external stakeholders to assure robust method development, transfer, and execution in GXP settings
• Mentor and train members of the analytical development team
• Author, review, and approve supporting reports and protocols

Requirements/Qualifications:

• B.S./M.S. or Ph.D. in Analytical Chemistry, Biochemistry, Biology with 3-7 years of industry experience
• Experience with mRNA LNPs is highly valued
• Experience with ELISA would also be desirable
• Prior experience with characterization and release/stability testing of formulated nucleic acids in lipid nanoparticles (LNP) preferred 
• Hands-on experience with various techniques such as sequencing, HPLC, CE PCR, ELISA, NMR, Bradford, SDS-PAGE, and UV/VIS spectrophotometry.
• Experience preparing technical documents for internal distribution and CMC regulatory filings 
• Demonstrated ability in working with highly skilled teams in a fast paced, entrepreneurial, and technical setting