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Director of R and D ► New Product Development for Biotechnology and Medical Device ► Jane.Schmidt.PhD@gmail.com ► I bridge science and business to drive product development success.I am known as someone who gets things done. I am outcome oriented. In my view, the role of Product Development teams is to provide the knowledge base to Operations to enable them to manufacture new products with processes that are reproducible and profitable. I am a practical problem-solver, who has the knowledge and experience to identify what will work; often the critical step is to state the problem clearly and correctly, keeping the ultimate goal in mind. I organize projects and processes with good metrics that help track progress and define success.I recognize team members' accomplishments.I am an effective team player and team leader. I empower team members and delegate effectively by checking for understanding and commitment and by holding individuals accountable. I recognize team members' accomplishments. Team members feel trusted and valued. I organize practical systems to support team efforts, communicate progress, and establish a record of what was done.I am also known for my technical and analytical skills. I am curious and engaged in a continuous quest for learning. I dig deep into the data to try to understand everything it has to tell. I am skilled in Design of Experiments (DOE) and statistics.My interests include biomarkers, assay development, surfactants, biomaterials.
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Director Of Multiplex Immunoassay R&DR&D Systems Feb 2008 - Aug 2014Greater Minneapolis-St. Paul AreaDirected staff of 12 to develop new multiplex immunoassays; 104 new products released in FY13. Led redevelopment of multiplex immunoassay product line to address declining sales; sales increased 52% in last FY due to new products. Instituted team approach to product development; reduced lead time as much as 75%. Led team to optimize manufacturing processes and transfer from Development to Operations. Participated in market research including competitor product analysis and voice of customers. Presented workshops and posters at conferences, interacted with customers to increase knowledge of and interest in multiplex immunoassay product line.Evaluated innovative assay technologies for potential as new product lines. -
Director Of Product DevelopmentDiasorin Jan 2005 - Jun 2007Greater Minneapolis-St. Paul AreaDirected staff of 15 scientists and technicians with budget of $2.1 million to meet corporate product development plan. Performed new product development in accordance with ISO, FDA, GLP/GMP guidelines. Launched 7 new or improved FDA-approved diagnostic assays in 2.5 years in compliance with ISO and GLP/GMP guidelines. Reorganized interdepartmental Core Team meetings to improve management of development projects at all levels. Developed detailed protocols and standardized spreadsheets in accordance with external guidance documents for clinical data in support of FDA and international regulatory submissions. Initiated system integration program to enhance product performance and reliability. Managed annual performance reviews and compensation changes for staff, addressed performance issues. Improved communication within department and instituted program of employee recognition to improve morale and reduce turnover. -
R&D Scientist IiiDiasorin Apr 2003 - Jan 2005Greater Minneapolis-St. Paul AreaDeveloped steroid assays for automated chemiluminescent immunoassay system. Introduced use of statistical methods for Design of Experiments (DOE) to improve decision making and reduce product development time. Generated and reported verification and validation data in support of FDA and international regulatory submissions.
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Staff ScientistBeckman Coulter 2000 - 2003Greater Minneapolis-St. Paul AreaDeveloped reagents to support immunoassay development for an automated enzyme immunoassay system for in vitro diagnostics. Developed and optimized scalable manufacturing processes for solid phase microparticles, enzyme conjugates, and antibodies; wrote SOPs; transferred to Operations. Led Development team to replace surfactant in critical system fluid impacting entire product line.
Jane Schmidt, Phd Skills
Jane Schmidt, Phd Education Details
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Biochemistry -
Chemistry -
University Of Minnesota -
University Of Delaware
Frequently Asked Questions about Jane Schmidt, Phd
What is Jane Schmidt, Phd's role at the current company?
Jane Schmidt, Phd's current role is Director of Process Development at Biothera.
What is Jane Schmidt, Phd's email address?
Jane Schmidt, Phd's email address is ja****@****ail.com
What is Jane Schmidt, Phd's direct phone number?
Jane Schmidt, Phd's direct phone number is +161237*****
What schools did Jane Schmidt, Phd attend?
Jane Schmidt, Phd attended Iowa State University, Macalester College, University Of Minnesota, University Of Delaware, University Of Iowa.
What skills is Jane Schmidt, Phd known for?
Jane Schmidt, Phd has skills like Biotechnology, Assay Development, Immunoassays, Protein Chemistry, Elisa, Immunology, Life Sciences, Medical Devices, Lifesciences, Biochemistry, Fda, Gmp.
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