Scientist, Drug Product Analytical

NewLimitSouth San Francisco, California, United States · Posted 3 months ago

Full-timeEst. 150,000 USD

Description

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

In your role as a Scientist, you will:

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

Salary Range: $130,000 to $170,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. NewLimit offers a competitive benefits package, which includes a 401k, healthcare coverage, and 20 days of PTO. Learn more at: https://www.newlimit.com/careers *This compensation and benefits information is based on Company's good faith estimate as of the date of publication and may be modified in the future.