Location: Boston,MA, USA
Title: Data Scientist
Location: Boston, MA (Hybrid)
Duration: 6m+
Data Scientist to join a growing team in support of commercial Cell and Gene Therapy programs. This position will be responsible for providing technical support in alignment with defined program priorities linked to data analysis, data trending and report generation.
Key Responsibilities:
Support development of data trending visualizations using Statistica and Spotfire including IPC, CPP and CQAs
Assist in the Development of Routine Data Visualization
Develop scripts for automated reporting of trends and correlations
Develop visualization for acknowledged alarm reporting and trending
Author SOP to standardize the process of pulling trend reports from TIBCO.
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.
Minimal Requirements:
MS with 5+ years, or BS with 8+ years of experience
Experience with either Statistica or Spotfire, both preferred
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.
Knowledge of technology transfer, process validation, and commercial lifecycle management.
Lab experience in cell culture preferred.
Experience with cGMP regulations/guidance and experience with regulatory agency inspections preferred.
Experience with developing CMC content and knowledgeable on regulatory guidance and trends preferred.