Anna Lutz Email & Phone Number

Madison, Wisconsin, United States

Madison, Wisconsin Area

Madison, Wisconsin Area

Madison, Wisconsin Area

Technical/Operational Liaison for Asia Pacific Region and a secondary role providing support Technical Support for the U.S. Market. Coordinator and facilitator on Quality, Regulatory, Technical and Logistical aspects of launching/maintain Molecular Products in the Asia Pacific Region.

I started my career as Scientist in Research and Development performing basic R&D and assay development functions. I had the privilege to work on a Perioperative Grant building custom Invader assays. I was also tasked with a project to design and develop Plasmid Controls for one of the product lines. I then moved into product development projects working to prepare technical documentation to be compliant with the FDA and the Hologic Product Development Process. In my product development role I wrote and executed verification/validation protocols as well as wrote and collaborated on the associated reports. I was also responsible for designing studies to meet various development needs (Equivalency Studies, Shipping Studies and Stability Studies). I worked as a core team member to launch FDA approved products.I then moved into a Product Support under the R&D umbrella. In this role I was given the opportunity to take a leadership role. I trained, mentored and coached fellow scientists. I also lead and managed projects providing creative solutions to our management team to overcome issues with the current product lines. I was able to work closely with Regulatory to assist in preparation of submission packages for the U.S. as well as for International Markets specifically our Asia Pacific markets of interest. I became the lead for all Asia Pacific product support functions. I also lead U.S. based failure investigations and Corrective Action and Preventative Action Plans. In addition, I was an active leader on the Product Outsourcing Team.

I worked to manufacture oligonucleotides as well as QC test then using a Mass Spectrometer.

Wildlife Biology

Education record