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The Data Scientist will support the MSAT organisation at Orchard Therapeutics and will lead data-driven initiatives to support process and analytical control strategy development, trend monitoring, manufacturing investigations and lifecycle management of cell and gene therapy products. This role will be the primary point of contact for the development and implementation of a centralised manufacturing data repository, ensuring seamless data integration from CDMOs and internal data repositories. The job holder will drive insights that enhance process understanding, control and continuous improvement. The role will include the creation of specific processes to ensure seamless and compliant data flow and integration, data interpretation and analysis to support multiple MSAT activities linked to successful manufacture of CGT products. This role is also critical to enabling understanding of complex manufacturing processes and product characterisation.
This is an exciting opportunity to work with vector, cell process, and analytical scientists involved with Chemistry, Manufacturing, and Control (CMC) data management of gene therapy products, from early phase development to commercial production. The candidate should have experience using a variety of data mining/data analysis methods, as well as a strong statistical knowledge, DoE study experience and hands-on experience with JMP or similar software and building appropriate systems to interrogate database. Experience in working in a regulated environment is essential and the candidate must have a passion for discovering solutions hidden in large data and be comfortable working with a wide range of stakeholders and functional teams to improve process outcomes.
RequirementsRequired Experience & Knowledge:
- Experienced in statistical modeling, multivariate data analysis and process analytics and experienced with applications (e.g. JMP…)
- Proficiency using programming languages (e.g. R, Python, SQL, SAS, etc.) to manipulate data and draw insights from large data sets
- Proficient in DoE applied to biological processes
- A solid understanding of biological and bioprocessing concepts, data, and information types, experience working with CGT processes and analytical method is a plus
- Experience building databases compliant with requirements for regulatory filings (ICH Q8-Q10, Regulatory CPV guidance)
- Experience using/developing data visualization tools
- Knowledge of GMP data integrity, process validation (PPQ) and CPV principles
- Demonstrated experience applying knowledge in relevant industry fields such as Biopharma, CGT or manufacturing data analytics
Skills and Abilities
- Strong analytical and problem-solving skills
- Ability to translate complex dataset into actionable insights
- Ability to work in and lead diverse cross-functional teams
- Attention to detail and compliance mindset
- A drive to learn and master new technologies and techniques
- Excellent communication skills with an ability to visualize / present data to communicate ideas, concepts and results to technical and non-technical audiences (both internally and externally)
- Interest in continuous improvement of processes by integrating innovative solutions
Education
MSc or PhD in data sciences, statistics, bioprocess engineering, Bioinformatics, Engineering or related discipline.
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