Vertex MSAT team is seeking a Senior Principal Data Scientist to support commercial Cell and Gene Therapy programs by leading and providing technical support in data acquisition, analysis, trending, visualization, and reporting.
Requirements
- Significant experience with data software packages including Statistica and Spotfire at a minimum.
- 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 designing automated trend outputs
- Experience with process characterization and process control strategy preferred.
- Experience with cGMP regulations/guidance and with regulatory agency inspections preferred.
Responsibilities
- Identify and develop technical solutions to enable program and company goals.
- Lead development of data trending visualizations using Statistica and for process parameters
- Lead 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.
- Author technical protocols, reports, and other GMP supporting documents.
Other
- PhD, MS, or BS in relevant science or engineering discipline.
- Ability to travel, nationally and internationally, up to 10 - 15%.
- Flexibility to work on site a minimum of 3 days per week.
- Excellent communication skills, both written and verbal
- Ability to work within a team and independently
