Senior Scientist, Bioanalytical Sciences (Cambridge, MA)
- 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.
- 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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