Shire Human Genetic Therapies

Business Challenge: Project Managing a Fix Ross Project

In 2005 Tranksaryotic Therapies, Inc. (TKT) of Cambridge, MA was acquired by Shire Pharmaceuticals Group plc resulting in the formation of Shire HGT. TKT gave Shire HGT significant expertise in the discovery, development, manufacturing and marketing of protein therapeutics. 

TKT was a user of Ross ERP and in 2006 & 2007 Shire HGT implemented Ross ERP manufacturing, sales and financials. The implementation of Ross at Shire HGT was not a success, in particular the  manufacturing implementation  was  poorly  managed  by  the  former services  provider  who  lacked sufficient  knowledge  of  Ross ERP  and  failed  to  provide proper  training  and transfer  sufficient  knowledge  to  Shire  users.  

As  a  result,  master  database  elements were  built  with  overly  complex  structures, adequate testing  was  not  provided  and  a forced go live was executed that resulted in chaos for the business.

After a business review in early 2008 it was decided to re-implement Ross ERP through a Fix Ross project. Calvin Smucker was appointed as project manager of this re-implementation. In mid-2008, Calvin and his team set about fixing Ross. This was a three year project, but positive results were not only achieved in phases, but the first results were seen in a matter of months. 

Phase 1 tackled the issue of the poorly implemented manufacturing system.  The  structuring  of 30  plus stages within a recipe line was a gross misuse of the system and at the core of problems associated  with  inventory  accuracy,  untimely  transactions  and  accounting  variances.

Phase 2 followed immediately on the heels of the success of the initial effort with requests for additional improvements in other functional areas and for assistance with operational expansion in Europe. 

Calvin’s role soon expanded to also include systems administration and management, including help desk support, user training, auditing, and systems validation.

Phase 1

  • Restructure the overall manufacturing process

  • Streamline specifications and recipes

  • Streamline job processing

  • Improve cost allocations and variance analysis

  • Correct master data and configuration setup

  • Update inventory processes and improve accuracy

  • Implement quality control enhancements

  • Improve Business Objects reporting

  • Process Validation

Phase 2

  • Material management improvements

  • Quality Control enhancements

  • Distribution controls and process enhancements

  • Implement cycle counting

  • MRP improvements

  • Configure additional factories and warehouses

  • Job processing improvements

  • Lot sequence number management at the unit level

  • Streamlining European operations

  • Complex structuring of EU external freight distribution warehouses

  • Configuration for EU companies in Italy, Greece, Portugal, Turkey

  • New division for unique drug supply chain and finance requirements

  • Configuration for EU contract manufacturing

  • Sales Order automation across multiple companies and countries

  • Data Collection implementation

  • Finance improvements and modifications

  • Ross/SAP interface and data exchange

  • Process Validation

Systems Management

  • Ross Managed Services

  • Business Objects & SciQuest Managed Services

  • Security Administration

  • Biannual Financial Audits

  • SOX Compliance

  • System Validation (GMP)

  • User Training

Fix Ross was a huge success for Shire, allowing them to grow from 400 to 1200 staff and open a state-of-the-art facility in Lexington, MA. This was followed by the addition of yet another manufacturing location and a significant supply chain and operations expansion across both the US and Europe. This growth was in no small part due to the project management skills of Calvin Smucker who oversaw the project from day one until its completion.