Job Description
The client is seeking an experienced Senior Scientist to join their Bioanalytical Sciences team. In this hands-on, lab-based role, you will lead the design, development, and execution of regulatory-aligned bioanalytical assays supporting IND-enabling studies for our mRNA-LNP therapeutics. You will be a subject matter expert in nucleic acid and protein bioanalysis, working to generate critical data that informs decision-making across preclinical and clinical development. You will be instrumental in building client’s IND readiness and advancing our genetic medicine platform. You will report into the VP, Head of DMPK and Clinical Pharmacology, with the expectation to be onsite 5 days a week. This is an individual contributor role.
You will: - Design and execute phase-appropriate bioanalytical strategies for mRNA-based delivery systems
- Develop, optimize, and qualify RT-qPCR-based assays for quantifying LNP-delivered mRNA in biological matrices
- Develop and oversee ligand-binding immunoassays (ELISA, MSD, Luminex or similar platforms) for the detection of translated proteins and anti-drug or anti-protein antibodies, including screening, confirmatory, and neutralizing antibody assays in accordance with regulatory guidance
- Collaborate with stakeholders in DMPK, Toxicology, Clinical, and Regulatory to ensure assay readiness, study support, data integrity, and reporting across GLP and non-GLP studies
- Become a bioanalytical SME for external CROs to ensure method transfer, scientific rigor, compliance, and execution of assay development, sample analysis, and method validation/qualification
- Review, interpret, and present bioanalytical data to teams; contribute to the authorship of study reports, assay qualification/validation summaries, and regulatory documentation (e.g., IND Module 4/5)
- Ensure all analytical work is conducted in alignment with regulatory expectations and fit-for-purpose principles
- Stay current on emerging technologies and industry standards in nucleic acid and protein bioanalysis.
Qualifications: - Ph.D. in Biochemistry, Molecular Biology, Pharmaceutical Sciences, or a related field with a minimum of 5 years of industry experience; an M.S. with 8+ years of relevant industry experience will also be considered
- Prior contribution to IND submissions or regulatory responses related to bioanalysis
- Experience with nucleic acid bioanalysis using RT-qPCR for quantifying mRNA or oligonucleotides in preclinical or clinical settings
- Experience developing and qualifying ligand-binding assays (ELISA, MSD, Luminex) for protein quantification and ADA characterization
- Experience managing outsourced bioanalytical work, including CRO oversight, protocol review, and data quality control
- Familiarity with regulatory guidance (e.g., ICH M10) and FDA/EMA expectations for bioanalytical support of IND submissions
- Experience with data interpretation
- Commitment to our Core Values: Respect, Integrity, Excellence, and Impact
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