Stephanie Carleton Email & Phone Number

Leverkusen, North Rhine-Westphalia, De

Lead Global Trait submission plans and strategy by driving timely submission support strategies for Trait Submissions. Coordinate and partner with key stakeholders to prioritize and track projects, manage resource demand and predict potential bottlenecks that could impact submissions. Manage data tools to access, track and maintain project information. Establish processes for data governance. Coordinate across Global Regulatory Affairs Seeds and Traits the information, decision making and processes to support financial needs, budget and forecasting.

Leverkusen, North Rhine-Westphalia, De

Manage all seed movement between divisions globallyEnsure all Regulatory Sciences regulated seed movement/release is compliant with global trait quality and stewardship policies AND meets the host country governments GMO regulations and lawsCreate complex Breeding Trees for the Seed and Traits portfolio that meets all requirements of countries included for global dossier submissionsand is responsible for answering all regulator questions regarding these Breeding Trees;Collaborate with Regulatory Stewardship and Compliance in developing strategy and implementing trait quality management processes within Regulatory Science functionsDrive strategy for process improvement, automation and IT solutionsWrite SOPs for complex technical operations and processes to ensure complianceEnsure compliance with safety, BioSafety and stewardship standards and traceability through appropriate quality management and informationsystems

Leverkusen, North Rhine-Westphalia, De

• Develop and drive a trait quality strategy across the Biotechnology organization• Partner with stakeholders to define scientific and operational risk factors and implement Corporate-level trait quality policies and procedures• Define trait quality requirements for new technologies• Collaborate across functions and testing labs to assess, develop and implement firewall testing strategies and identify business needs and manage issue resolution• Provide direction for IT system development and improvements

St. Louis, Missouri, Us

• Lead Scientist responsible for the support of current and future global regulatory submissions of biotechnology enhanced plant products by developing, validating and distributing PCR-based detection methods• Support existing regulatory applications by generating data and/or responses to address comments from Regulatory agencies worldwide concerning detection method submissions• Prepare and review reports and dossiers to support regulatory submissions• MTC representative on a Product Core Team• Monsanto representative for Crop Life International Detection Methods Project Team• Lead the process/efficiency improvements for the Detection Methods team• Co-leader of compliance activities for the Molecular Technical Center• Member of cross-functional committees including MTC/PTC Compliance Steering Team, MTC/PTC Events Team, Document Automation Team

St. Louis, Missouri, Us

• Study director responsible for method development, optimization and documentation in a GLP environment for large scale in vitro transcription of RNA, DNA sequencing and northern blot analyses of transgenic corn• Characterization of test substance, including determination of experimental acceptance criteria needed to generate a certificate of analysis• Dose confirmation studies to support a mouse oral gavage toxicology study• Establishment of guidance documents and worksheets to drive accuracy and consistency between analysts• Prepare reports to support regulatory submissions• Review reports and data for content, accuracy and adherence to SOPs• Primary contact for multiple cross-discipline collaborations• Member of several cross-functional committees including Compliance and Quality Steering Teams, EPA Inspection Readiness Team and Safety Inspection Team

Atlanta, Ga, Us

• Lead Scientist for test substance production, including method development, optimization, production and documentation in a GLP environment• Characterization of test substance, including determination of experimental acceptance criteria needed to generate a certificate of analysis• Establishment of guidance documents and worksheets to drive accuracy and consistency between analysts• Prepare reports to support regulatory submissions• Review reports and data for content, accuracy and adherence to SOPs• Primary contact for multiple cross-discipline collaborations

Columbia, Mo, Us

• Responsible for design, execution and statistical analyses of experiments• Assay development, including Taqman assays, animal exercise protocols and antibody characterization• Lab animal husbandry and genotyping, including assay improvement• Lab manager in charge of personnel, general lab organization and operations• Teaching laboratory classes to undergraduate biochemistry majors• Responsible for manuscript and grant preparation• Responsible for presentation of data at regional, national and international meetings

Columbia, Mo, Us

• Responsible for design, execution and statistical analyses of dissertation research (project entitled titled “The Role of Genetic Background on the Phenotypic Severity of the Osteogenesis Imperfecta Murine (oim) COL1A2 Gene Mutation Throughout Postnatal Development”) • Assay development, including Taqman assays, biomechanical testing and collagen quantification• Responsible for manuscript and dissertation preparation• Responsible for presentation of data at regional, national and international meetings• Lab animal husbandry and genotyping

Fort Lauderdale, Fl, Us

I was a member of the corn production team whose duties included embryonic transformation, tissue culture and development of callus into seedlings.

Iowa City, Iowa, Us

As a summer intern, I worked on a project titled "The molecular response of Arabidopsis thaliana to flooding" in the laboratory of Dr. Ming-Che Shih. This project entailed tissue culturing of the plants, RNA extraction and quantitation and protein analysis using the GUS reporter gene as a marker.

Phd, Genetics

Bs, Biology