Representative ETS Projects and Solutions:
Management Consulting
- Led the executive team (CEO, CFO and direct reports) of a privately held medical device manufacturer in determining establishment of its own European operations after European license agreement was terminated by its major European pharma partner. ETS developed and maintained project scope, schedule and budget. Met weekly with executive team to review project schedule, track progress, identify issues and assign action items. Provided turnkey ERP commissioning services with Epicor technical assistance in execution.
Tech Transfer/Process Engineering
- During a tech transfer, the need was determined to deliver WFI to three separate bays when the original design accounted for only one; finding a way to expedite delivery of sanitary valves to accommodate two additional bays, ETS successfully reached out to its network of vendors to receive product in time for scheduled shutdown, then install, program and qualify product in advance of test runs.
- During a pilot to commercial scale tech transfer, unexpectedly the process filtration of a suspension plugged repeatedly, prompting cancellation of the engineering run campaign. It was initially thought that the root cause was due to the head pressure needed to overcome the elevation of the return piping. ETS developed a model using the pump curve and was able to illustrate this was not the case. Shortly thereafter, the same model exposed the root cause. ETS gave its recommendations to the client, which were implemented in advance of the next campaign, and proved to be successful.
- During clinical runs, the client's process encountered plugging during its filtration step. ETS assessed the root cause to be thermal loading of the copolymer membrane used in its process. The client asked ETS how it proposed to prove its hypothesis. ETS proposed a test method and sent the suspect membrane to its major university research partner. There, a PhD materials engineer performed DMA and Scanning Electron Microscopy to verify that thermal loading was root cause.
Finance
- During tech transfer of a commercial product, when the client's expectations in the monthly financial reporting structure could not be met by its CMO, ETS went to work right away to custom develop the financial model needed by its client without compromise to the project timeline.
- When it was learned that the client was reassessing the packaging requirements in Phase 2 of a tech transfer to its CMO, ETS presented client with an off-balance sheet finance alternative that improved the payback to less than one year. ETS went out to its network and arranged a contract with a commercial bank with attractive equipment lease terms, including an option to buy after year four.
Serialization
- ETS was engaged as the program manager to lead an aggressive six-month schedule that consisted of a complete packaging line upgrade (including serialization), a retrofit of one existing syringe line (to accommodate a new syringe presentation and new product), and the serialization (plus qualification) of 21 new packaging recipes to satisfy the client's new market expansion. ETS developed a programmatic schedule across four packaging lines leveraging a core team of process, controls, packaging and manufacturing engineers along with specialists in SAP, quality and procurement to specify, procure and receive the new components required for each recipe qualification. 21 recipes were completed on time. Resultantly, Q1 2019 packaging actual vs. planned output increased 200%.
Strategic Planning
- ETS was retained to develop a Transition Plan that mapped out the resources across three shifts needed by its packaging department to ensure the 200% output improvement was sustained. Immersion training on new equipment was key. ETS found a Chicago junior college within driving distance from the client that had just completed a $45MM expansion containing the exact equipment used by the client. The college has committed to develop a customized program for the client.