Principal Scientist, Cell Therapy Translational Biology Research

Position Responsibilities

• Develop and lead focused research projects, exercising independent judgment in experimental design, execution, and interpretation
• Plan, direct, and execute laboratory research to characterize product/candidate function and inform clinical interpretation and indication strategy
• Design and lead non-clinical/translational data packages to support regulatory submissions and indication expansion for cell therapy programs
• Contribute to biomarker strategy and patient stratification approaches to guide clinical decision-making
• Lead the development, design, and optimization of novel in vitro assays and models to advance translational research objectives
• Investigate the impact of manufacturing and process changes on product functional comparability to support regulatory filings and process decisions
• Represent Translational Biology on cross-functional, multi-disciplinary program/project teams spanning Discovery, Clinical, Regulatory, and Manufacturing
• Contribute to the writing of non-clinical pharmacology study reports, investigator brochures, IND applications, regulatory annual reports, and other regulatory documents when appropriate
• Coordinate external collaborations and/or be the subject matter expert
• Act as a technical point of contact and functional mentor to junior scientists
• Present data and analysis at cross-functional program and team meetings; contribute to conference abstracts, manuscripts, and patent disclosures
• Contribute to lab stewardship initiatives to support productivity, safety, and inspection readiness

Basic Qualifications

• Bachelor’s Degree 8+ years of academic and / or industry experience
• Or Master’s Degree 6+ years of academic and / or industry experience
• Or Ph.D. or equivalent advanced degree in Life Sciences 4+ years of academic and / or industry experience

Preferred Qualifications

• M.S. or Ph.D. in immunology, molecular and cellular biology, or relevant discipline
• M.S. with 6+ years or Ph.D with 4+ years of experience, preferably in the biotechnology or pharmaceutical industry setting, or demonstrated deep experience in immunology or cell therapy academic research
• Expertise in immunology or cellular biology is required, knowledge of fundamentals of oncology and/or autoimmune and inflammatory diseases is desirable
• Familiarity with and experience in the drug development process from IND filing to late stage development in an industry setting is desirable
• Demonstrated ability to independently design, execute, and interpret complex experiments, adapting standard methods and techniques as needed
• Expertise in flow cytometry and cell culture/imaging techniques
• Experience with Incucyte software, JMP and GraphPad prism
• Experience analyzing high content (eg, transcriptomic, proteomic) datasets
• Experience with Electronic Lab Notebooks (ELN) and detailed protocol/process documentation is required
• Excellent communication and interpersonal skills, evidenced by strong ability to interact with and influence research scientists, project teams, and outside collaborators
• Detail-oriented with the ability to identify and implement creative solutions
• Ability to prioritize and manage time efficiently