Principal/Senior Scientist, Translational Biomarkers

South San Francisco. Posted 7 months ago

The role

You will lead the discovery, development, and qualification of pharmacodynamic biomarker assays. You will characterize the biological activity of mRNA-LNP medicines in preclinical and IND-enabling studies.

What you will do

Discover pharmacodynamic biomarkers to support clinical development of drugs
Own the design, development, and qualification of PD biomarker assays
Define go/no-go criteria for biomarker advancement
Contribute to PD biomarker strategy in regulatory submissions
Drive data analysis, interpretation, and reporting for bioanalytical studies
Contribute to sample processing workflows including tissue harvesting and primary cell culture
Mentor research associates
Establish SOPs

Required qualifications

PhD in molecular biology, biochemistry, cell biology, or a related field or equivalent industry experience (5+ years)
3+ years of hands-on experience in various quantitative bioanalytical assay platforms (e.g., RT-qPCR, ddPCR, ELISA, MSD, Olink, SOMAscan, NGS-based methods) in complex biological matrices (serum, plas
Strong working knowledge of bioanalytical method qualification/validation principles for PD biomarker measurements, including familiarity with ICH M10 guidelines and fit-for-purpose frameworks
History of delivering results for bioanalytical projects
Experience with primary cell culture and tissue-derived sample workflows

Nice to have

Experience in bioanalytical method transfer and CRO management for outsourced discovery or assay qualification work
Familiarity with preclinical drug development timelines and regulatory submissions (IND, TGA, CTD format)
Experience in LNP-RNA biodistribution and PD assay development
Experience developing products in emerging therapeutic modalities (gene therapy, nucleic acid therapies, cell therapy)

Benefits

Comprehensive Health, Dental, and Vision insurance
401(k) plan with company match
Paid parental leave
20 days of PTO per year plus holidays
On-site meals and snacks

About the company

NewLimit is a biotechnology company working to radically extend human healthspan. They develop medicines to treat age-related diseases by reprogramming the epigenome.