KM and Data Analytics Lead

The Company is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. We are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.  

• Lead routine analysis of data to monitor whether the process remains in a state of control, to be able to identify trend early.  Develop KPI dashboards to illustrate ongoing manufacturing performance based on key metrics.  Lead weekly meetings to review dashboards with technical team.
• Identify and implement best-in-class end-to-end electronic data management for CAR-T product development and manufacturing, working in collaboration with internal IT, partner company, and external vendors.
• Support investigators to provide data summaries, dashboard, relevant data for deviation investigation.  Support investigators with statistical analysis as needed.
• Enable data integration across multiple manufacturing sites / locations.
• Ensure appropriate compliance for the capture of the various categories of data generated (21 CFR Part 11).
• Act as key point of contact for downstream data inquiries / provision of data for manufacturing / clinical / commercial analyses, regulatory filings, quality investigations.
• Work with relevant stakeholders across the program to identify relevant data streams, and critical data points within, for inclusion within integrated database.

• A minimum of a Bachelor’s degree in biology, science, engineering or related field or equivalent experience required. Advanced degree preferred.
• 5-7 years of experience within a cGMP environment in the biotech/biopharma industry. Cell/Gene Therapy cGMP manufacturing experience preferred.
• Ability to work with paper and electronic system for data compilation including MES, SAP, LIMS, etc.
• Able to analyze data quickly and in sufficient detail to identify trends and then drill down to potential root causes.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Build strong partnerships with Manufacturing, Engineering and Quality to ensure seamless execution of daily production schedules.
• Strong technical CAR-T knowledge to be able to determine relationships between process parameters to support investigational analysis.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Clear and succinct verbal and written communication skills.