Senior Director, Advanced Analytics and Data Science at Orchard Therapeutics

TD is an end-to-end technical development (TD) and organization responsible for the development and manufacturing of Orchard’s HSC-based gene therapy pipeline which is actively collaborating with internal stakeholders and external CDMOs to develop innovative technical solutions to bridge early-stage, late-stage and commercial product needs. The Senior Director, Advanced Analytics and Data Science will spearhead the scientific and technical development of industry-leading techniques to profile gene therapies at a cellular level and data analysis platforms for precisely evaluating the performance of CGT products. This will be an individual contributor role purposed with driving scientific breakthroughs and technology innovations that create differentiated capabilities, intellectual properties and competitive advantages for Orchard and ensure timely and robust implementation of appropriate product quality attribute strategies. Responsibilities: - Set the vision, and architect the path to delivering advanced analytical and data science strategies for the characterization of novel manufacturing processes and specific Orchard’s development programs in close partnership with technical and regulatory functions at Orchard and CDMOs - Lead the development of breakthrough analytical techniques aiming at achieving enhanced characterization, elucidate safety profile of gene therapies at cellular level and achieve advanced control over manufacturing consistency - Source, manage, and analyze large amounts of unstructured data via quantitative algorithms and statistical tools to address technical questions and drive program strategies - Design analytical development strategies for Orchard’s programs in support of regulatory filings enabling strong analytical packages and robust control strategies ensuring product quality and compliance with applicable ICH guidelines and FDA/EMA and other global health authority requirements and expectations - Serve as a subject matter expert, author and/or review relevant sections of CMC documentation in support of regulatory submissions, amendments as well as interactions with regulatory authorities - Co-accountable (with Process Development functions) for development, implementation, and execution of a manufacturing technology roadmap in-line with Orchard’s manufacturing strategy - As a key opinion leader both internally and externally on technology trends in the industry, influence and drive cross organization and cross industry discussion on the current focus and future of analytics and data science; mentor and inspire analytical experts, instill scientific rigor and enhance process knowledge across organizations - Proactively engage in collaboration with internal organisations (e.g. Research, Clinical Development and Operations, Quality, Manufacturing) and external stakeholders (e.g. CDMOs, contract testing labs) including health authorities and industry trade organizations to identify trends and expectations and incorporate them into Orchard’s analytical development and control strategies - Actively support inspection readiness activities and associated Health Authority Inspections; ensure quality, regulatory and EHS compliance

Senior Director, Advanced Analytics and Data Science

Responsibilities

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About Orchard Therapeutics:

mission:

www.orchard-tx.com/

Admin access needed