Visp, Valais, Switzerland
Qualified Biotechnologist with Engineering in biotechnology. Currently working as a Process Validation manager Lonza, Switzerland. Gained ~15 years of Expertise in downstream manufacturing processing, MSAT, R&D and Pilot of Bacterial, mammalian and cytokines. Highly motivated, positive and goal-oriented with demonstrated professionalism. Involved in commissioning of new plant. Personally, I am a modest, honest, hard-worker and enthusiastic person able to accept responsibility, to work independently or collaboratively, under pressure and with deadlines. I have the ability to interact with different departments, to negotiate as well as to deal with people and manage quality documentation. I am habituated to innovation, international environments and changes. My motivation is to continue developing my career in a dynamic biotechnological/pharmaceutical company and utilize completely my accumulated experience and knowledge. Target the fullest extent possible, becoming a valuable asset for the company in the research and manufacturing areas of a (bio)pharmaceutical organization. Always ready to take new challenges
Process validation, Continued process verification, Product Quality Reviews.
Technology transfer, Risk assessment, facility fit assessment, Internal and External stakeholders management, Process gap assessment.
Responsible for the internal and external tech transfer. Trouble shooting of process and product related concerns. Process gap analysis, risk assessment and mitigation plan, data analysis and related data review. Preparing "Request for Information" (RFI) for the external customers. Coordination with cross functional team.
Responsible for monitoring, supporting and improvement of day to day activities in downstream R&D. To lead the discussion related to downstream process and trending of process parameters. Review the protocols, SOP and lab note books.
Working with multiple clients to carry out Bacterial and mammalian purification at pilot scale. Responsible for monitoring, supporting, and improvements of day to day activities. Coordinate and drive the downstream process activities for smooth functioning. Led single use technology for 2KL mammalian green field project.