How does the customer benefit?
Complex projects are planned transparently and scalably, a realistic cost estimate is produced at the beginning as decision base for the management, the project is then adapted to management’s expectations and performed within planned time and cost frames. Thereof results the best quality and functionality at a minimal expense. Often the leadership of large projects borders on interim leadership of departments or companies. Based our broad experience in interim leadership assignments in the industry, the customer benefits through our simple, robust and effective concepts and new external ideas.
Case 1:
A cGMP / FDA readiness project (80 internal part time FTE in 17 teams, 2 years) for a leading global, pharmaceutical company was planned and led by us. We prepared and led the kick-off workshop (80 FTE, 2 days) where the action list for the project was developed, elaborated the project plan and cost estimate, negotiated the final shape of the project with the senior management and together with a peer led the project to success. Furthermore, of the 17 teams of this project, we led 2, built and led 1 group of 14 FTE and 3 labs within the project.
Case 2:
For a global big pharmaceutical company MVLSC planed and led a cGMP / FDA readiness project (60 internal part time FTE, 8 external FTE for 1.5 years). MVLSC analyzed the company and its cGMP status, planned and led an internal workshop, developed a project plan and cost estimate, rescaled the project according to the senior management’s expectations, helped to hire the external experts and led the project to success.
Case 3:
To achieve a turnaround of an unprofitable (- 40%) API manufacturing site (100 FTE) of a global CRMO-company (Contract Research & Development and Manufacturing Organization) M. Vavrecka was appointed. After analyzing the situation, he produced and implemented a tailored operational strategy and consequent management by objectives. The site achieved a break-even in the first year. Subsequently further improvements were achieved through a continuous improvement initiative and a culture change towards ownership and performance. At the end of this 4 years project the site was 35% profitable, which was seen as a great success by the senior management.
Case 4:
To achieve a turnaround of the operations of a midsize, global CRMO company manufacturing APIs (400 FTE) M. Vavrecka was appointed. The turnaround was achieved within half a year through clear formulation of the overall company goals and a consequent breakdown of the goals down to daily employees’ activities in order to focus all energy of the company on the target, combined with a continuous improvement initiative and management by objectives.
Case 5:
As consequence of the closure of an US site, 150 manufacturing processes for fine chemicals had to be transferred to a Swiss manufacturing site of a midsize global CRMO. We were responsible for the transfer at the Swiss side. This challenging project was completed successfully within a year.
Case 6:
A sudden high market demand in a specific API had been anticipated by M. Vavrecka, who consequently instigated and led a project of a 20-fold capacity increase of this API within half a year in a midsize, global CRMO. This included the installation / qualification of new equipment, manufacturing process transfer into 4 sites (2 UK, 1 US, and 1 in Ireland), and finally added 20% more sales and even more profit growth to the company’s profit and loss account (PLA).
Case 7:
For the implementation of a SAP system in a major API production site of a leading global pharmaceutical company M. Vavrecka was appointed SAP validation manager. He was responsible for planning and implementation of all quality relevant activities of the project (e.g. URS and all subsequent documents of the CSV phases, validation plan, test readiness plans and checks, testing, change control, validation report, open issue log etc.). The project (25 internal, 40 external FTE, 1 year) was accomplished slightly ahead of the schedule, to budget and with excellent functionality and quality (successfully audited later on).
Case 8:
In the production of a major manufacturing site of a midsize global CRMO for historical reasons there were no manufacturing process risk assessments in place. The legal issue was aggravated by the fact that the site had 2’500 standing products and some 100 new one off products per year. We developed a process risk assessment system that allowed to risk assess the new incoming products on current base and all the outstanding ones within 2 years with no additional resource.
Case 9:
A 2’000 l paddle dryer had to be installed for API production in a leading global pharmaceutical company. M. Vavrecka led this CHF 5 million engineering project, including the dismantling of several equipment units and rebuilding of an equivalent at another place besides the installation of the dryer with clean room cabins for charge and discharge. Since this project was part of the launch of a high priority innovative medication, it was quite pressed for time. However, it was accomplished in time and to the planned cost and functionality.
Case 10:
To replace the exhaust air collection and disposal system (ALURA) in a production site of a midsize global CRMO M. Vavrecka was appointed project leader. The challenge of this engineering project was that it was highly safety relevant and interconnected within and outside of the ALURA system. The project was finished within cost, time and budget frames.
