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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)
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