Scientist, Drug Product Analytical

NewLimit; South San Francisco (CA); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) with company match

Paid parental leave

20 days of PTO + holidays

Meals and snacks on-site

Job summary

NewLimit, a biotechnology company based in South San Francisco, is looking for a skilled Scientist to join their Delivery Sciences team. This role involves building analytical methods for Lipid Nanoparticles and supporting nucleic acid delivery technologies in drug product development. Candidates should hold a Ph.D. and possess knowledge in mRNA-LNP systems. Generous benefits include health insurance, a 401(k) plan, and 20 paid time off days per year.

Qualifications

• 1-3 years of industry experience with direct experience working with mRNA-LNP delivery systems.
• Expertise in Ion-Pair Reversed-Phase Chromatography for determining RNA purity.
• Experience developing RNA integrity analysis in both Drug Substance and LNP Drug Product.

Responsibilities

• Design and execute analytical methods to assess the identity and purity of RNA drug substances.
• Work with cross-functional teams to support RNA and LNP analysis.
• Author high-quality technical reports and validation protocols.

Skills

Analytical Chemistry

Biochemistry

Pharmaceutical Sciences

mRNA-LNP delivery systems

Ion-Pair Reversed-Phase Chromatography

Capillary Electrophoresis

DLS/MALS/Cryo-TEM

Education

Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field

Tools

JMP

Python

R

Job description

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‑dose 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)

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.