Stephanie Carleton

Stephanie Carleton Email and Phone Number

Operations Lead, Regulatory Affairs at Bayer Crop Science @ Bayer
Stephanie Carleton's Location
St Louis, Missouri, United States, United States
Stephanie Carleton's Contact Details
About Stephanie Carleton

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.

Stephanie Carleton's Current Company Details
Bayer

Bayer

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Operations Lead, Regulatory Affairs at Bayer Crop Science
Stephanie Carleton Work Experience Details
  • Bayer
    Regulatory Affairs Operations Lead
    Bayer Jun 2022 - Present
    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.
  • Bayer
    Stewardship And Trait Quality Lead, Regulatory Sciences
    Bayer May 2020 - Jun 2022
    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
  • Bayer
    Senior Process And Compliance Manager (Formerly Trait Quality Lead)
    Bayer Sep 2017 - May 2020
    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
  • Monsanto Company
    Molecular Analyst, Nucleic Acid Detection
    Monsanto Company May 2013 - Sep 2017
    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
  • Monsanto Company
    Molecular Analyst, Molecular Characterization
    Monsanto Company Aug 2012 - May 2013
    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
  • Randstad Usa
    Molecular Analyst
    Randstad Usa Jul 2011 - Aug 2012
    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
  • University Of Missouri
    Post Doctoral Fellow
    University Of Missouri Nov 2006 - Jul 2011
    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
  • University Of Missouri
    Graduate Fellow
    University Of Missouri Aug 2001 - Oct 2006
    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
  • Todays Staffing
    Laboratory Technician
    Todays Staffing Mar 2001 - Jul 2001
    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.
  • University Of Iowa
    Howard Hughes Undergraduate Research Fellow
    University Of Iowa Jul 1999 - Aug 1999
    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.

Stephanie Carleton Skills

Tissue Culture Pcr Dna Western Blotting Sds Page In Vitro Transcription Rna Biology Gel Electrophoresis Biomechanics Qpcr Genetics Biochemistry Assay Development Dna Sequencing Elisa Rna Isolation Biotechnology Molecular Biology Polymerase Chain Reaction Electronic Laboratory Notebook Template Design And Validation Good Laboratory Practice Regulated Industry Electronic Lab Notebooks Document Automation

Stephanie Carleton Education Details

  • University Of Missouri-Columbia
    University Of Missouri-Columbia
    Genetics
  • Lindenwood University
    Lindenwood University
    Biology

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?

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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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