Scientist, Drug Product Analytical

About the role

NewLimit is a biotechnology company focused on extending human healthspan through the development of medicines that target age-related diseases. Our approach involves reprogramming the epigenome and uses functional genomics, pooled perturbation screening, and machine learning to study the biology of epigenetic aging and disease.

Position

We are seeking a Scientist to join our Delivery Sciences team. The ideal candidate will focus on developing analytical methods to characterize Lipid Nanoparticles (LNPs) and support the drug product development for our nucleic acid delivery technologies.

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 drug substance and drug product analytical method development, validation phases, and PK/PD assay developments
• Interpret data from various analytical assays, reports, 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 with 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 determining RNA purity, integrity, and content
• Experience with Liquid Chromatography - Atmospheric Pressure Chemical Ionization (LC-CAD) for lipid purity, content, and lipid adducts analysis
• Capillary Electrophoresis (CE) experience in developing RNA integrity analysis for both Drug Substance (DS) and LNP Drug Product (DP)
• Expertise in Dynamic Light Scattering (DLS), Multi-angle Light Scattering (MALS), and Cryo-Transmission Electron Microscopy (Cryo-TEM) for particle size, polydispersity, and particle distribution analysis

Nice to have

• Understanding of ICH guidelines regarding method qualification and validation (ICH Q2 (R1) and Q14)
• Proven success in tech-transferring analytical methods to Contract Development and Manufacturing Organizations (CDMOs)
• Experience with DOE, data visualization, and statistical analysis tools (JMP, Python, R)

Benefits

• Health, dental, and vision insurance
• 401(k) with company match
• Paid parental leave
• Industry-leading paid time off (PTO) — 20 days/year for all employees + holidays
• Meals and snacks on-site

Pay

$130,000 to $170,000

Schedule

Full-time