Ultragenyx is looking to solve the problem of rare disease medicine by developing data management solutions to enable monitoring of ongoing GMP production and drive process improvements for future lifecycle management.
Requirements
- Understanding of biologics/AAV manufacturing process is required
- Experience in manufacturing technical support, process development, and/or MSAT roles is preferred
- Demonstrated experience in data management, process modeling, and predictive analytics, preferred with GMP environment
- Proficiency in biostatistics and data management tools (e.g., DOE, multivariate analysis, regression, Python/R/SAS).
- Experience with regulatory filing is a plus
- Strong foundation in biologics/AAV process knowledge combined with statistical expertise
- Proficiency in programming languages such as Python, R, or SAS
Responsibilities
- Build and implement the Continued Process Verification (CPV) framework for AAV programs, including online/offline data management solutions, data integrity verification process, statistical tools and predictive models to monitor and improve batch performance.
- Establish and oversee systems for data collection, monitoring, and analysis systems for early and late-stage programs, ensuring compliance with 21 CFR Part 11 and alignment with regulatory expectations.
- Develop and apply advanced statistical data modeling approaches (e.g., multivariate analysis, regression, machine learning techniques) to enable predictive modeling, deviation investigations and continuous improvement.
- Support data review and report writing with data trending and statistical models, for proactively actionable recommendations
- Support deviation investigations and tech transfer activities by leveraging statistical expertise to analyze historical data, and to set or revise in-process control limits.
- Lead initiatives to develop platform process models (HEK vs. HeLa) across multiple GMP manufacturing sites to support proactive process monitoring; stay current with the AAV manufacturing technology innovations, and support implementation of process improvements for life cycle management.
- Collaborate with Global CMC Development, external CDMOs, Manufacturing, Quality Assurance, Quality Control, and other stakeholders to enable robust CPV strategy execution.
Other
- Master’s degree in Virology, Molecular Biology, Genetics, Biochemistry, Chemical Engineering, Bioinformatics, Biostatistics or an equivalent discipline preferred
- 5+ years in biopharma industry. Biologics, Gene / Cell therapy experience preferred
- Proven ability to deliver results successfully, collaborating with multi-cultural and geographically diverse teams
- Demonstrated ability to work in a team and in a fast-paced environment. Proven ability to independently manage multiple competing priorities, while working on multiple projects simultaneously
- Excellent communication and presentation skills
