Legend Biotech US is hiring a Principal Scientist to provide scientific leadership and hands-on flow cytometry expertise. You will support our cell and gene therapy programs from IND-enabling studies through late-stage clinical development. Your work will ensure scientific rigor and data quality across both in-house and outsourced flow cytometry activities.
What You'll Do
- Lead the design, development, optimization, qualification, and validation of multicolor and spectral flow cytometry assays for IND-enabling animal studies and clinical trials.
- Provide expert guidance on panel design, antibody qualification, gating strategies, and data analysis for complex immunophenotyping.
- 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 quality standards, regulatory expectations, and program timelines.
- Identify risks related to assay performance and data quality, and implement mitigation strategies.
- Author, review, and approve bioanalytical assay validation reports, study reports, and regulatory documentation.
- Ensure flow cytometry 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, 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.
What We're Looking For
- 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.
Nice to Have
- 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.
Technical Stack
- Multicolor flow cytometry platforms
- Spectral flow cytometry platforms
Team & Environment
You will be joining the Research & Early Development team.
Benefits & Compensation
- Medical, dental, and vision insurance
- 401(k) retirement plan with a company match that vests fully on day one
- Eight (8) weeks of paid parental leave after just three (3) months of employment
- Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
- Flexible spending and health savings accounts
- Life and AD&D insurance
- Short- and long-term disability coverage
- Legal assistance
- Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
Work Mode
This is a hybrid position based in Somerset, NJ.
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. We are an equal opportunity employer.
