Vertex Pharmaceuticals is seeking a Principal Data Scientist to support commercial Cell and Gene Therapy programs by providing technical support for data acquisition, analysis, trending, visualization, and reporting.
Requirements
- Significant experience with data software packages including Statistica and Spotfire at a minimum.
- Strong understanding of Statistics
- Experience with cell therapy or large-scale GMP manufacturing for biopharmaceutical manufacturing
- Experience with designing process monitoring tools to detect OOT/OOE
- Experience with designing process visualization tools to show process trends
- Experience with process characterization and process control strategy is a plus.
- Experience with cGMP regulations/guidance and with regulatory agency inspections is a plus.
Responsibilities
- Identify and develop technical solutions to enable program and company goals.
- Lead/support development of data trending visualizations using Statistica and for process parameters
- Lead/support the Development of Routine Data Visualization charts and tools
- Develop scripts for automated reporting of trends and correlations
- Develop visualization for acknowledged alarm reporting and trending
- Author SOPs and work instructions to standardize the process of pulling trend reports from TIBCO.
- Support and author technical protocols, reports, and other GMP supporting documents.
Other
- PhD, MS, or BS in relevant science or engineering discipline.
- PhD with 3+ years, MS with 5+ years, or BS with 9+ years of experience.
- Ability to work within a team and independently
- Provide regular (weekly) updates towards project goals.
- Ability to travel, nationally and internationally, up to 10 - 15%.
