Scientist, Drug Product Analytical

About the Company

NewLimit is a biotechnology company working to radically extend human healthspan. We’re developing medicines to treat age-related diseases by reprogramming the epigenome, a new therapeutic mechanism to restore regenerative potential in aged and diseased cells.

Responsibilities

• Design and execute analytical methods to assess the identity, integrity and purity of RNA drug substances and LNP drug products and LNP-conjugates
• Perform deep-dive analysis into mRNA integrity, identity, lipid content and identity analysis to support drug product stability studies
• Work closely with cross-functional teams to support RNA and LNP analysis from early discovery to GLP/GMP stages
• Act as a technical expert for CRO/CDMO partners on analytical method development, validation, and PK/PD assay developments
• Interpret data from various analytical assays and prepare data packages
• Author high-quality technical reports, SOPs, and validation protocols to support regulatory filings

Requirements

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field
• 1-3 years of industry experience with direct experience working with mRNA-LNP delivery systems
• Expertise in Ion-Pair Reversed-Phase Chromatography (IP-RP LC-UV/FLR) for RNA purity and integrity
• Expertise in LC-CAD for lipid purity and content analysis
• Experience with Capillary Electrophoresis (CE) for RNA integrity analysis
• Expertise in DLS, MALS, or Cryo-TEM for particle size and distribution analysis

Preferred Qualifications

• Understanding of ICH guidelines (ICH Q2 (R1) and Q14)
• Proven success in tech-transferring analytical methods to CDMOs
• Proficiency in DoE, data visualization, and statistical analysis (JMP, Python, R)

Benefits

• Health, dental, and vision insurance
• 401(k) with company match
• Paid parental leave
• 20 days of PTO per year plus holidays
• On-site meals and snacks