McCune Management Consulting, LLC
   
 

Project Management

Successful management consulting projects utilizing cross-functional teams to implement business process change, system implementation, or outsource implementation require very strong project management skills: planning, organization, communication, and accomplishing tasks through other people.

Program Management Office

Large, complicated initiatives with multiple teams assessing or implementing change typically require central coordination. A Program Management Office (PMO) provides central coordination, communication, issue escalation, decision support, project management resources, resource allocation, budget approval etc. for multiple active projects. 

Representative PMO Projects

Pre-commercial biopharmaceutical drug developer with an innovative drug delivery device – lack of process rigor and staff capability required organizational transformation, interim management, and process design to prepare for initial licensing by the FDA

  • As Director of Materials, responsible for procurement, planning, inventory control, and warehousing for drug and device manufacturing – Staff of 15 and $50 million annual spend
  • Developed and implemented supply chain and cGMP policies and procedures
  • Increased cycle count accuracy from 35% to 98% in 3 months
  • Increase MRP system accuracy from 7% to 86% in 3 months
  • Increased BOM accuracy from 42% to 91% in 3 months
  • Increased drug expiration accuracy from 50% to 77% in 2 months (100% at use)
  • Evaluated ERP products and participated in selection of JD Edwards
  • Assisted program management office (PMO) to manage over a dozen client teams

Pre-commercial biopharmaceutical vaccines – a failed inspection by the FDA faulted insufficient operational processes, calling for new leadership in process design and implementation

  • Designed and implemented cGMP material control processes to prepare for FDA inspections
  • Managed four teams across three sites (Philadelphia, Santa Clara, and Mountain View)
  • Assisted program management office (PMO) managing 22 consultants and over 50 teams

Client achieved FDA approval of Pre-License Inspection (PLI)