Sr. Scientist, Bioanalytical Biomarker Sciences
$136,000–$154,000 year
On-siteCambridge, Massachusetts, United States
Job Summary
Design and execute bioanalytical and biomarker assay development, qualification, and validation activities, including ligand-binding and immunogenicity assays, to support drug candidate selection and regulatory submissions. Generate and oversee bioanalytical data in partnership with PK scientists to inform dose selection for Phase 1–3 clinical siRNA candidates. Serve as the bioanalytical and biomarker lead on multidisciplinary project teams, managing CRO activities and preparing high-quality summaries and regulatory document contributions for INDs/CTAs. Ensure compliance with regulatory guidelines and SOPs across all bioanalytical and biomarker-related activities. This role reports to the Head of Bioanalytical and Biomarker Sciences within the Translational Sciences team at City Therapeutics, based in Cambridge, MA.
Required Qualifications
- Ph D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 3–5+ years of relevant industry experience
- M.S. with 6+ years of relevant industry experience
- Strong expertise in regulated bioanalytical assay development, including assay qualification, validation, and regulatory requirements to support nonclinical and clinical studies
- Proficiency across multiple bioanalytical assay platforms, including ligand-binding assays, and immunogenicity assays in support of PK, PD, biomarker, and anti-drug antibody assessments
- Experience managing CRO relationships and externalized bioanalytical activities, including SOW preparation, review, implementation, study execution, data review, and timely delivery of high-quality reports
- Familiarity with regulatory expectations and guidance relevant to early-stage drug development
- Demonstrated adaptability, ownership, and collaborative mindset, with the ability to manage diverse responsibilities and shifting priorities in a dynamic, fast-paced environment
- Excellent problem-solving, analytical, and communication skills, with the ability to interpret complex quantitative data and clearly convey key findings to diverse scientific, clinical, regulatory, and cross-functional audiences
- Proven experience developing and supporting bioanalytical and biomarker assays for oligonucleotide therapeutics, with experience in siRNA or other RNA-based modalities
- Experience working with CROs and managing outsourced bioanalytical and biomarker assay activities, including assay development, qualification, validation, sample analysis, data review, troubleshooting, and report finalization
- Experience supporting IND/CTA-enabling studies and/or early clinical development programs, including generation and interpretation of bioanalytical data for regulatory submissions
- Knowledge of regulatory bioanalytical guidance and expectations, including FDA, EMA, and ICH guidelines
Desired Qualifications
- Preferred experience developing and supporting bioanalytical and biomarker assays for oligonucleotide therapeutics, with experience in siRNA or other RNA-based modalities
- Experience working with CROs and managing outsourced bioanalytical and biomarker assay activities, including assay development, qualification, validation, sample analysis, data review, troubleshooting, and report finalization
- Experience supporting IND/CTA-enabling studies and/or early clinical development programs, including generation and interpretation of bioanalytical data for regulatory submissions
- Knowledge of regulatory bioanalytical guidance and expectations, including FDA, EMA, and ICH guidelines
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.