Principal/Senior Scientist, PK/PD Assays

- Own the end-to-end design, development, and qualification of PK and PD biomarker assays across various platforms to support preclinical and IND-enabling studies

- Discover and validate pharmacodynamic biomarkers to support the clinical development of drugs across multiple programs

- Drive data analysis, interpretation, and reporting for bioanalytical studies to support program decision-making with audit-ready data packages

- 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

- 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 PK/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

- Track record of bioanalytical method transfer and CRO management for outsourced projects

- Familiarity with preclinical drug development timelines and regulatory submissions (IND, TGA, CTD format)

- Experience with mRNA-LNP biodistribution or nucleic acid-based PK assays

- Experience developing products in emerging therapeutic modalities (gene therapy, nucleic acid therapies, cell therapy)

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

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. 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.