Scientist, Drug Product Analytical

About NewLimit

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. We leverage functional genomics, pooled perturbation screening, and machine learning models to unravel the biology of epigenetic aging and disease using experiments of unprecedented scale.

Position

We are seeking a skilled and motivated Scientist to join our Delivery Sciences team. In this role, you will focus on building the analytical methods to characterize Lipid Nanoparticles (LNPs) to enable our nucleic acid delivery technologies and support the drug product development.Expertise in developing and implementing analytical methods to characterize RNA drug substances and LNP drug products, with experience managing method qualification, validation, and tech-transfer processes.

What you'll do

• 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 the cross-functional teams to support RNA and LNP analysis for drug development from early discovery to GLP/GMP stages. Act as a technical expert for our 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
• IP-RP LC-UV/FLR: Expertise in Ion-Pair Reversed-Phase Chromatography for determining RNA purity, integrity and content
• LC-CAD: Expertise in method development for lipid purity, content and lipid adducts analysis.
• Capillary Electrophoresis (CE): Experience developing RNA integrity analysis in both Drug Substance (DS) and LNP Drug Product (DP)
• DLS/MALS/Cryo-TEM: Expertise in 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.
• DoE, data visualization and statistical analysis (JMP, Python, R)

Benefits

NewLimit offers generous benefits to ensure our team can focus on our mission:

• 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