Sr. Principal/Principal Scientist
- Lead the design, development, optimization, qualification, and validation of multicolor and spectral flow cytometry assays supporting IND-enabling animal studies and clinical trials.
- Provide subject-matter expertise in panel design, antibody and reagent qualification, gating strategies, and data analysis for complex immunophenotyping applications.
- Conduct deep scientific review and interpretation of flow cytometry datasets to support PK/PD, mechanism-of-action, and translational insights.
- Serve as the primary scientific lead for external laboratories and CROs performing flow cytometry assays.
- Oversee assay transfer, validation, execution, troubleshooting, and data delivery at CROs.
- Ensure outsourced activities meet Legend quality standards, regulatory expectations, and program timelines.
- Identify risks related to assay performance, data quality, and operational execution, and implement mitigation strategies.
- Author, review, and approve bioanalytical assay validation reports, study reports, and regulatory documentation.
- Ensure flow cytometry assays and data packages are inspection-ready and compliant with GxP principles and data integrity requirements.
- Contribute to bioanalytical sections of IND and other regulatory submissions.
- Partner with Clinical, Translational Research, Biomarkers, Nonclinical Safety, and Data Science teams to align assay strategy with program objectives.
- Provide scientific input to study design, endpoint selection, and interpretation of bioanalytical results.
- Communicate complex data clearly to multidisciplinary stakeholders.
- Establish and maintain SOPs, best practices, and governance for in-house flow cytometry workflows.
- Mentor and scientifically guide junior scientists and associates.
- Evaluate and implement new technologies, platforms, and analytical approaches to enhance capabilities.
- Ph.D. in Immunology, Cell Biology, Molecular Biology, or related discipline with 8+ years (Principal Scientist) or 10+ years (Senior Principal Scientist) of relevant industry experience; or M.S. with 12+ years of experience.
- Extensive hands-on experience with multicolor and spectral flow cytometry platforms.
- Demonstrated experience supporting cell therapy and/or gene therapy programs.
- Strong understanding of bioanalytical method development, validation, and regulatory expectations.
- Proven ability to lead complex programs, influence cross-functional teams, and provide strategic scientific direction.
- Experience overseeing CROs and external vendors.
- Excellent written and verbal communication skills.
- Experience with CAR-T, in vivo gene delivery, or other advanced cell therapy platforms.
- Experience contributing to IND-enabling or regulatory filings.
- Background in translational PK/PD applications of flow cytometry.
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