Visp, Valais, Switzerland
Experienced Project Manager with a demonstrated history of working in the pharmaceuticals industry. Skilled in Process Assessment, Research and Development (R&D), Chemical Engineering, Troubleshooting, and Technology Transfer. Strong program and project management professional with a Doctor of Philosophy (Ph.D.) focused in Organic Chemistry from Universität des Saarlandes.
Responsible for clinical trial phase III projects and commercial products (drug substance). The projects are often complex consisting of several manufacturing steps (up to 12) and stretch across all manufacturing sites in Switzerland. This requires supervising sub-project teams at these sites. List of activities/tasks: Evaluation of RFQs from customers, preparation of quotes, arrange human and plant resources and setup of project teams, primary contact to the customers leading phone conferences, contribution in process optimization and debottlenecking discussions, guidance in troubleshootings, issuing and reviewing of project and process validation documentation, triggering and reviewing of documents as part of the deviation and change control processes, logistics for customer provided and contract manufactured materials, represent chemical/technical part of the projects in audits, occasionally review of CMC documents ...
Preparation of technical process transfer documents. Supervise and manage the transfers. Alignment with internal and external stakeholders - especially internal production planning. On-site Production support and trouble shooting at CMOs (primary Far East).
Evaluation of technical packages and preparation of cost calculations for quoting purposes. General evaluation of fit to plants (feasibility check) was followed by an in-depth analyses of the process. This included generating a high-level plant setup for the process, identifying potential debottlenecking options, generating high-level project plans (R&D, key raws lead times, time for manufacturing) in cooperation with production planning and resource managers. Technical discussions with process providers if required. Calculation of manufacturing costs including costs for raw materials in collaboration with the purchasing department. Furthermore definition of working packages for the R&D organization. The results of such evaluations were compiled to a "cost estimate" document.
Familiarization with and evaluation of organic synthetic processes (pharma and crop protection). Generating all required data to allow a smooth transfer into plant. Troubleshooting of running products. Supervising a group of about 6-7 chemists and up to 14 lab technicians. Responsible for the expertise evaluation on job interviews and instruction of new colleagues on their job.