Program ManagementLead , manage and deliver global and x-functional projects/programs, end-to-end, applying PMI methodology effectively.Raise any project/program scope ambiguity with Senior Leadership, seek clarity to be able to design detailed project plans and roadmaps.Manage the execution and completion of the defined project plans/roadmaps through effectively coordinating people and resources.Capex LeadLead project team(s), build and maintain relationships with vendors and contractors and cross interaction with validation engineers, facility management, and operations; mitigate risks and ensure compliance with regulations and legal requirementsLead technical activities for product transfers (process, technology, analytics, capacity, resources)Lead the definition and selection of manufacturing equipment, providing input to User Requirements.Responsible for introducing and validating new equipment and/or complex new process projects from design through completion and in regulatory compliance.Investigates and evaluates existing technology and/or designs new methodology, machines, fixtures, or processes, as needed, for the manufacture of new medical device products at various scales during development and through commercialization.

Lead technical activities for product transfers (process, technology, analytics, capacity, resources)Lead the definition and selection of manufacturing equipment, providing input to User Requirements. Responsible for introducing and validating new equipment and/or complex new process projects from design through completion and in regulatory compliance.Investigates and evaluates existing technology and/or designs new methodology, machines, fixtures, or processes, as needed, for manufacture of new medical device products at various scales during development and through commercialization.

Responsibility for design and execution of Key Strategic investment projects (cost, time schedule, quality, functionality).  Management of large investment projects according to customer needs. Minimization of life cycle costs and project schedules. Management of internal and external resources in an international environment. Implementation of state of the art safety/ecology standards according project needs. Ensuring sharing and leverage of best practices and expertise in the projects.In another project, I manage a huge international development project, implementing subcontractors, managing the supply chain, overseeing the transfer of the analytical methods, production and the overall technical readiness to conduct a GMP manufacturing at the CMO.

Ensure planning of new projects. Supervise commissioning, qualification /validation for equipment.Monitor operational key performance metrics. Retain and develop employees. Deputize the director of operation

Improve the department's quality, customer service and environmental performance.Implement quality improvement principles to streamline the production process.Ensure that the department meets national and international compliance standards.Lead and motivate multi-disciplinary teams

Responsable for Packaging OperationsResponsable for Engineering and Technology developmentIn charge of Facility ManagementMember of the Board

Responsable for the manufacturing, the primary packaging and the secondary packaging departement In that role i am in charge of:overseeing the production process, ensuring that the production is cost effective,making sure that products are produced on time and are of good quality,working out the human and material resources needed, drafting a timescale for the job,estimating costs and setting the quality standards, monitoring the production processes and adjusting schedules as needed, being responsible for the selection and maintenance of equipment;monitoring product standards and implementing quality-control programmes;liaising among different departments, e.g. suppliers, managers;working with managers to implement the company's policies and goals;ensuring that health and safety guidelines are followed,supervising and motivating a team of workers, reviewing worker performance, identifying training needs.

Member of the founding team.I was responsible for the refurbishment and compliance of the building. Head of facility management, engineering and production.I was also responsible for GMP compliance and I represented the company in authority and client audits.

Head of qualification and validation.I implemented a new SOP concept and developped the new validation strategies for processes, analytical methods as well as cleaning validation.

Head of the Immunochemistry reagent production In addition to my responsability in Switzerland i was in charge of the technical transfer and the production move to Penzberg in Germany from 1997 to 2000