Principal/Senior Scientist, Translational Biomarkers

This Position

NewLimit is seeking a Senior/Principal Scientist with deep expertise in molecular biology and translational biomarker assay development. In this role, you will lead the discovery, development, and qualification of pharmacodynamic (PD) biomarker assays that characterize the biological activity of our mRNA-LNP medicines in preclinical and IND-enabling studies. You will serve as a technical leader within our bioanalytical function, shaping PD biomarker strategy from discovery through fit-for-purpose qualification to advance our therapeutic programs toward clinical milestones.

What you'll do

• Discover pharmacodynamic biomarkers to support the clinical development of drugs across multiple programs
• Own the design, development, and qualification of PD biomarker assays across various platforms to support preclinical studies
• Define go/no-go criteria for biomarker advancement and contribute to the PD biomarker strategy in regulatory submissions
• Drive data analysis, interpretation, and reporting for bioanalytical studies
• Contribute to sample processing workflows including tissue harvesting, primary cell culture, and complex matrix handling
• Mentor research associates, establish SOPs, and build institutional knowledge within the bioanalytical function

Requirements

• 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, plasma, tissue homogenates)
• 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 -- you've discovered a PD biomarker or built an assay and solved all the problems along the way
• 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

NewLimit provides generous benefits so our team can remain focused on our mission:

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

Salary Range

$155,000 to $200,000. 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.