MSAT Principal Scientist, Data Science and Automation Engineering

Role Summary

MSAT Principal Scientist, Data Science and Automation Engineering role supporting commercial Cell and Gene Therapy programs. Responsible for technical support aligned with program priorities related to data acquisition, analysis, trending, visualization, and reporting.

Responsibilities

• Identify and develop technical solutions to enable program and company goals.
• Lead/support development of data trending visualizations using Statistica 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.
• Contribute to developing technical solutions to enable program and company goals.
• Ability to work within a team and independently.
• Provide regular (weekly) updates towards project goals.

Qualifications

• Experience with cell therapy or large-scale GMP manufacturing for biopharmaceutical manufacturing is required.
• 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.
• Significant experience with data software packages including Statistica and Spotfire at a minimum.
• Strong understanding of Statistics.
• 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.
• Experience working and leading projects in a matrixed organization.
• Experience working with external partners (CMOs, vendors, etc.).
• Excellent communication skills, both written and verbal.
• Ability to travel, nationally and internationally, up to 10 - 15%.
• Flexibility to work on site a minimum of 3 days per week.

Skills

• Data analysis and visualization
• Scripting for automated reporting
• GMP/regulatory awareness
• Cross-functional collaboration

Education

• PhD, MS, or BS in relevant science or engineering discipline