Stephanie Carleton Email and Phone Number
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Analytically minded “science nerd” who enjoys asking “what if?” I am a strategic thinker with the ability to bring diverse groups together, motivate others, successfully organize and manage multiple projects and meet deadlines in a fast-paced, changing environment.
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Regulatory Affairs Operations LeadBayer Jun 2022 - PresentLeverkusen, North Rhine-Westphalia, DeLead 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. -
Stewardship And Trait Quality Lead, Regulatory SciencesBayer May 2020 - Jun 2022Leverkusen, North Rhine-Westphalia, DeManage 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 -
Senior Process And Compliance Manager (Formerly Trait Quality Lead)Bayer Sep 2017 - May 2020Leverkusen, 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 -
Molecular Analyst, Nucleic Acid DetectionMonsanto Company May 2013 - Sep 2017St. 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 -
Molecular Analyst, Molecular CharacterizationMonsanto Company Aug 2012 - May 2013St. 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 -
Molecular AnalystRandstad Usa Jul 2011 - Aug 2012Atlanta, 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 -
Post Doctoral FellowUniversity Of Missouri Nov 2006 - Jul 2011Columbia, 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 -
Graduate FellowUniversity Of Missouri Aug 2001 - Oct 2006Columbia, 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 -
Laboratory TechnicianTodays Staffing Mar 2001 - Jul 2001Fort Lauderdale, Fl, UsI was a member of the corn production team whose duties included embryonic transformation, tissue culture and development of callus into seedlings. -
Howard Hughes Undergraduate Research FellowUniversity Of Iowa Jul 1999 - Aug 1999Iowa City, Iowa, UsAs 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.
Stephanie Carleton Skills
Stephanie Carleton Education Details
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University Of Missouri-ColumbiaGenetics -
Lindenwood UniversityBiology
Frequently Asked Questions about Stephanie Carleton
What company does Stephanie Carleton work for?
Stephanie Carleton works for Bayer
What is Stephanie Carleton's role at the current company?
Stephanie Carleton's current role is Operations Lead, Regulatory Affairs at Bayer Crop Science.
What is Stephanie Carleton's email address?
Stephanie Carleton's email address is st****@****ail.com
What is Stephanie Carleton's direct phone number?
Stephanie Carleton's direct phone number is +152027*****
What schools did Stephanie Carleton attend?
Stephanie Carleton attended University Of Missouri-Columbia, Lindenwood University.
What are some of Stephanie Carleton's interests?
Stephanie Carleton has interest in Baking, Playing Piano, Reading.
What skills is Stephanie Carleton known for?
Stephanie Carleton has skills like Tissue Culture, Pcr, Dna, Western Blotting, Sds Page, In Vitro Transcription, Rna Biology, Gel Electrophoresis, Biomechanics, Qpcr, Genetics, Biochemistry.
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