My personal background

Based on my previous job activities, I gained substantial experience in automated analysis systems for the image-based and biochemical analysis of liquids like supernatants of cell cultures and microbial fermentation broths. In cooperation with a Japanese partner, I adapted the technology of several random access biochemistry analysers, designated for clinical purposes, to the requirements in the biotechnology industry in research. Together with one of the market leaders in Clinical Chemistry, we developed assays to fit the needs in the biopharmaceutical industry. I designed and executed validation procedures for various analysis systems. Based on the PAT initiative of the FDA, I designed innovative quality assurance procedures to increase the final quality of the therapeutic products. I have marketed products to the leading bio-pharmaceutical companies, manufacturing high-value products..

My communications skills, as well as my ability to adapt to foreign cultures and customs, were extremely helpful when establishing distribution partner networks in Asia, North Anmerica , and Europe. Beside Singapore, I have appointed new sales partners in India, China, Singapore, Taiwan, Japan and Korea. I supported the North American subsidiary in the market launch of our cell culture biochemistry analyser series CuBiAn.

I also focused on the application of image recognition based analyzers for mammalian, insect, and yeast cell culture. The majority of our customers were working in the cGMP-regulated environment, so I am familiar with the guidelines of the FDA and EMA for biopharmaceutical production of human and veterinary drug products.

Due to my keen perception, my strategic and creative thinking I was authorized by my former employers to handle new and complex projects. The autonomous execution of the projects comprised the design of project plans and test series, the generation of user requirement (URS) and design specifications (DS), based on cGAMP guidelines, the development of acceptance test criteria (IQ,OQ, and PC), and SOPs.

Beyond this, my knowhow and creativity was in demand for the generation of market launch strategies, including market and competition analysis, design of strategic plans for product launches, design of marketing tools, design and execution of marketing events. I was appointed as representative for special tasks in public relations.