McCune Management Consulting, LLC
   
 

Representative Projects

Developer of implanted medical device – marginal customer service capabilities were putting the introduction of major new product at risk for a billion dollar division

  • Assessed capabilities to support customer calls from health care professionals and patients at other divisions and corporate shared service organizations
  • Developed and evaluated potential service models – including outsourcing
  • Recommended partnering with another division to quickly ramp-up a high quality and low cost solution that represented the best strategic long-term fit
  • Assisted management to develop consensus among the business units within the division and gain buy-in with the other division and corporate management

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)