Responsibilities also include providing operational oversight of sample and case tracking and follow-up, optimizing testing strategies and assay services, performing data analysis, interpretation, data management and reporting, and supporting responses to regulatory inquiries. In the role as a Principal Scientist within Translational Research, the ideal candidate will: Execute cell therapy safety testing across assets in alignment with translational strategy, clinical development plan, and medical affair objectives. Communicate testing strategy, cumulated data, and milestones to cross-functional stakeholders, and engage with technical, scientific, medical/clinical, patient safety, and operational experts to align, revise, and incorporate testing plans. Track details associated with patient safety events on sample collection and testing for clinical and commercial settings to ensure timely testing and data delivery. Streamline testing processes and optimize assay services across; drive process improvement with cross-functional dialogue and operational engagement. Critically review, analyze, and interpret, safety test data, lead communication and reporting go internal and external stakeholders in clinical and commercial settings. Participate in reporting safety testing data in regulatory documents and contribute to responses to inquiries from health authorities and health care professionals. Build partnerships in a matrix environment, influence project strategies, and provide expertise in data analysis, reporting and interpretation. Must be able to set and understand priorities in a fast-paced matrixed environment, must be a team player with a collaborative spirit and work style, and capable of building and maintaining networks within and outside the organization. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Supporting People with Disabilities Bachelor's Degree 8+ years of academic and / or industry experience Ph.D. with 7+ years of combined postdoc training, clinical research, and industry or biotech experience, with expertise in immunology, molecular/cell biology, virology, and/or cell therapy research. Exceptional communication, interpersonal, and scientific writing skills, with proven ability to work collaboratively and adaptively in a highly matrixed environment and under tight timelines. Highly organized, detail-oriented, and scientific driven, with meticulous attention to data tracking and data management. Solid understanding of regulatory framework and requirements, including experience in drafting and reviewing regulatory documents and developing translational strategies. Demonstrated ability to build strong relationships with internal and cross-functional stakeholders; CRO experience and knowledge of CLIA/GCLP practices are a plus.