Project Description

ECA Case Study: Project Staffing

PMO Consultant,
FDA Approval

Pharmaceutical Co.


New York, NY

Post-MBA (1-2 years)

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Project Details

Client / Situation
  • Our client, a former Oliver Wyman consultant at an innovative firm, has just launched a blockbuster drug and was facing a tight timeline with a critical Pre-Approval Inspection (PAI) by the FDA
  • They were looking for a Strategic Advisor and Program Manager for the manufacturing facilities, engineering teams for the FDA PAI and critical GMP systems for commercial operations readiness
Objectives / Results Achieved
  • Provided operational leadership and quality assurance advisory for the facilities team responsible for validation, calibration, engineering, maintenance and environmental health and safety (EHS), which included risk evaluation, change control, deviations, standard operating procedures (SOP) and supporting the overall quality management system
  • Led the management of program milestones, timelines, risks and dependencies
  • Led utility contracts request for proposal (RFP) for natural gas and electricity contracts seeking a 5% to 7% cost reduction
  • Provided operational support for Environment Health & Safety (EHS) team by leading projects for wastewater permits, hazardous waste process improvement, and hazardous containment plans
  • Developed plan for critical spare parts for facilities maintenance, including a recommendation for inventory management system
  • Provided strategic advisory to Facilities, Engineering, Maintenance & Utilities group to re-define the scope of services provided, areas of responsibility and Identification of internal clients’ needs

ECA’s Life Sciences & Biotech Practice Lead

This is a picture of Jason Blonstein, Director of ECA
Jason Blonstein

Jason worked with many Life Sciences & Biotech clients at ECA. He would be happy to discuss your upcoming project and talent needs.


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