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Jenisch Consulting GmbH

Success Stories

Development of a strategy for a  large  Pharma production site and alignment with the global manufacturing strategy

Re-establishment of FDA compliance for a sterile drug product filling site

Development of a global multi-site strategy for the packaging of pharmaceutical products

Process optimization and reduction of inventory value for cold chain products

Development and implementation of business processes to manage a project portfolio

 

Development of a strategy for a  large  Pharma production site and alignment with the global manufacturing strategy

 

Starting position: A large Pharma production site, located in a high-cost country, with a very complex product portfolio and production equipment geared to large prodution orders. Future expecations are for small and flexible order sizes with short lead times. In addition, transfer of production to other countries is being considered.

Approach: Development of a new site strategy by analysing the current situation, identifying opportunities, creating a common vision and fortifying the new strategy via scenario planning. The new strategy comprised a concrete plan for activities within the site as well as the sites unique value proposition to be shared with decision makers.

Results: Today this production site continues to be one of the key sites within the company. New products as well as new technologies are actively transferred into this site.

 

Development and implementation of business processes to manage a project portfolio

Starting position: The department head "Strategy and Organizational Development" is new to the role. The organization struggles handling too many projects in parallel and priorities are not well aligned. In addition, key contributors are involved in too many initiatives at the same time.

Approach: I started by developing a new project portfolio management process as well as providing best-practise guidelines for project managers. To support this, we developed appropriate training materials and trained all involved employees in the new processes. Subsequently we made sure, that all projects would be executed based on the new processes and included into the portfolio. This newly created portfolio was then reviewed on a regular basis with the leadership team. Priorities were set based on the site strategy.

Results: The new process strengthened understanding within the organization on how the portfolio is managed and how it contributes to the realization of the strategy. The regular portfolio review led to full transparency and within two years, the number of projects was reduced by one third. Thanks to improved utilization of resources, efficiency in the projects as well as within daily operations was greatly improved.

 

Re-establishment of FDA compliance for a sterile drug product filling site

 

Starting position: A sterile drug product filling production site had gone through an FDA inspection which resulted in an extensive 483 almost leading to a warning letter. The site was also put on accelerated inspection schedule. The site itself was scheduled to be closed down, but was still running at over-capacity. In addition, half of the work force were contractors.

Approach: I started off by compiling an overall project plan, encompassing different work streams and including already ongoing activities. I emphasized strict prioritization and realistic sequencing of activities to ensure optimal utilization of scarce resources as well as minimizing and mitigating the risks for the upcoming inspection.

Results: Firm project management lead to an overall plan which made activities as well as the critical path transparent to all involved and ensured alignment with the daily operations of the plant. I regularly updated the stakeholders about progress, achieved milestones as well as highlighting potential risks and proposing appropriate mitigation. Project and risk mitigation activities were executed by the project team. As a result, the site passed the next FDA inspection without any major or repeat overservations. The project team was rewarded with a special prize within the division for their extraordinary work and accomplishments.

 

Process optimization and reduction of inventory value for cold chain products

 

Starting position: A production site which was producing and packaging cold chain products was using a third party warehouse to store these products. In more specific terms, this meant that products at different steps of the value chain were constantly moved between the site and the external warehouse. This resulted in long lead times, higher than necessary inventories and an increased product quality risk.

Approach: The inherent issues and consequences of this situation were not obvious, therefore I started by advocating a lean approach to improve processes, eliminate waste thus realizing signicant savings potential in lead times as well as inventory values. I lead an initiative mapping the entire value stream from receipt of raw materials to global distribution of finished products. I formed a powerful project team including representatives from the different production plants, quality assurance as well as the global planning functions and finance.

Results: Based on the results of the value stream mapping, the team proposed process improvements as well as a convincing business case for building a new cold chain warehouse on-site. This cold-chain warehouse was subsequently built and is fully operational today. In addition to yielding the desired benefits, this project also increased understanding of the value chain and improved collaboration between the involved organizations.

 

Development of a global multi-site strategy for the packaging of pharmaceutical products

 

Starting position: The global manufacturing network comprised 20 sites for pharmaceutical packaging mostly supplying the local markets. These sites were part of the local country organization and had no direct reporting line into the global network. Overall cost was higher compared to other competitors due to a lack of harmonization and integration as well as redundancies in the network.

Approach: I started by compiling an end to end view of the network encompassing technologies, volumes, different manufacturing steps as well as supply chain. Based on this I developed different strategic scenarios how the network could be structured working together with a team of representatives from the different sites. These scenarios were then evaluated and the preferred scenario was translated into a strategy and long-term execution plan.

Results: This strategy «pack where you produce» developed 20 years ago is still at hand. The number of sites in the network was reduced and today's sites are focused on core competencies (technologies) and efficiently integrated into the global network.