Experience

Praxis Precision Medicines, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Manager, Nonclinical Safety

  • Mar 2022 - Present

• Manager of Nonclinical Safety (Toxicology)

  • Dec 2020 - Mar 2022

  • Manage outsourcing of pre-clinical studies (GLP and non-GLP) for inclusion in regulatory submissions under aggressive timelines. • Oversee operational aspects of preclinical studies to ensure timely delivery of key data to inform project decisions. • Work within established CRO agreement terms to support preclinical development programs. Collaborate with internal toxicology, bioanalytical and other team members. • Participate in CRO qualification/scientific assessments and tracking… Show more • Manage outsourcing of pre-clinical studies (GLP and non-GLP) for inclusion in regulatory submissions under aggressive timelines. • Oversee operational aspects of preclinical studies to ensure timely delivery of key data to inform project decisions. • Work within established CRO agreement terms to support preclinical development programs. Collaborate with internal toxicology, bioanalytical and other team members. • Participate in CRO qualification/scientific assessments and tracking vendor performance. • Oversee CRO partners to ensure consistent practices across vendors, groups and sites, communicate and trouble-shoot issues and track/forecast activities and spending. • Helps manage the Master Schedule for both internal and external preclinical studies. • Track the preparation and review and manage the circulation of study documents. • Maintain complete, organized, and current study files including study schedules, contracts, protocols, and other applicable documents. • Manage report and sub-report timelines and ensure all study reports are appropriately organized and archived



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Toxicologist (Scientist I Toxicology)

  • Mar 2017 - Dec 2020

  -In July 2020, promoted from Associate Scientist II to Scientist I -Assist in the technical conduct of and/or compilation and interpretation of data from toxicology studies -Monitor technical aspects of study conduct -Support regulatory infrastructure in toxicology by evaluating and reviewing study related processes and practices -Provide assistance in scientific and/or regulatory input with study design, protocol preparation, study monitoring, in-life data evaluation and overall… Show more -In July 2020, promoted from Associate Scientist II to Scientist I -Assist in the technical conduct of and/or compilation and interpretation of data from toxicology studies -Monitor technical aspects of study conduct -Support regulatory infrastructure in toxicology by evaluating and reviewing study related processes and practices -Provide assistance in scientific and/or regulatory input with study design, protocol preparation, study monitoring, in-life data evaluation and overall conduct of preclinical studies -Setup and provide ongoing support for toxicology studies -Provide raw data review, and generate updates and reports Show less -In July 2020, promoted from Associate Scientist II to Scientist I -Assist in the technical conduct of and/or compilation and interpretation of data from toxicology studies -Monitor technical aspects of study conduct -Support regulatory infrastructure in toxicology by evaluating and reviewing study related processes and practices -Provide assistance in scientific and/or regulatory input with study design, protocol preparation, study monitoring, in-life data evaluation and overall… Show more -In July 2020, promoted from Associate Scientist II to Scientist I -Assist in the technical conduct of and/or compilation and interpretation of data from toxicology studies -Monitor technical aspects of study conduct -Support regulatory infrastructure in toxicology by evaluating and reviewing study related processes and practices -Provide assistance in scientific and/or regulatory input with study design, protocol preparation, study monitoring, in-life data evaluation and overall conduct of preclinical studies -Setup and provide ongoing support for toxicology studies -Provide raw data review, and generate updates and reports Show less



Covance

• United States
• Research Services
• 700 & Above Employee

• Bioanalytical Chemist (Analyst III BioA)

  • Jul 2015 - Mar 2017

  -Extract and analyze samples for various compounds and components in compliance with standard operating procedures and GLP and GCP regulatory agency guidelines. -Extraction techniques include: solid phase extraction, liquid liquid extraction, supported liquid extraction, and protein precipitation -Operates automated laboratory equipment as designated for client methods and studies -Participates in POD meetings and discussions with fellow team members on client studies to plan assigned… Show more -Extract and analyze samples for various compounds and components in compliance with standard operating procedures and GLP and GCP regulatory agency guidelines. -Extraction techniques include: solid phase extraction, liquid liquid extraction, supported liquid extraction, and protein precipitation -Operates automated laboratory equipment as designated for client methods and studies -Participates in POD meetings and discussions with fellow team members on client studies to plan assigned workload and schedule other study assignments according to the directives of the Lead Scientist and strict client deadlines -Operates HPLC and MS instrumentation and troubleshoots instrumentation as need to obtain optimal chromatography -Performs method validation testing as needed to support the validation team and maintain all analytical methods in compliance with current SOP’s and regulations -Currently acting as the POD lead chemist, coordinating LCMS instrument scheduling and sample analysis scheduling for a team of 6 chemists in addition to acting as the technical leader for the team -Assists with training and assimilation of new chemists -Performs QC review of data; Recognizes deviations from normal results and informs Study Director, Principal Investigator and/or management of any problems and/or deviations that may affect the integrity of the data.

• Senior Study Technician (Ocular and General Toxicology)

  • Jul 2013 - Jul 2015

  -Collect, document, and manage pertinent data including animal observations, test material administration, and clinical sample collection in compliance with appropriate SOPs and GLP -Read, interpret, and maintain functional knowledge of lab protocols, standard operating procedures, and government policies -Responsible for independently carrying out technical phases of most toxicology studies; Ensure the completion of a study within all applicable protocols and government… Show more -Collect, document, and manage pertinent data including animal observations, test material administration, and clinical sample collection in compliance with appropriate SOPs and GLP -Read, interpret, and maintain functional knowledge of lab protocols, standard operating procedures, and government policies -Responsible for independently carrying out technical phases of most toxicology studies; Ensure the completion of a study within all applicable protocols and government regulations -Responsibilities included study management, data organization, QA audit response, internal and external client communication, and quality check procedures -Monitored animal health and welfare in compliance with Animal Welfare Act and helped maintain facilities for compliance with the AALAC -Performed advanced dosing and clinical sampling techniques, including IV injection, sub-q injection, ocular instillation, intravitreous injection, sub-retinal injection, and oral gavage -Reviewed own and others data and identified potential problems, assisted and instructed less experienced staff -Utilize specialized computer software for execution of forms and generation of lab procedures -Successfully served as the lead technician for several GLP studies for major pharmaceutical companies, specializing in complex studies that focused on the ocular system -Involved in client tours and client interaction during study procedures



UW-Madison Department of Neurosurgery, Julie K. Olson Lab

• Madison, Wisconsin Area

• Research Assistant

  • Jan 2011 - May 2013

  -Executed a wide variety of research procedures and projects in support of the Principal Investigator and several graduate students for a university laboratory -Performed various microbiology lab procedures such as RNA Isolation, cDNA Synthesis, and Real Time PCR -Responsible for preparing and maintaining culture plates of cells harvested from nervous system tissues -Prepared samples for ELISA and Western Blot analysis -Regularly performed advanced animal research techniques such as… Show more -Executed a wide variety of research procedures and projects in support of the Principal Investigator and several graduate students for a university laboratory -Performed various microbiology lab procedures such as RNA Isolation, cDNA Synthesis, and Real Time PCR -Responsible for preparing and maintaining culture plates of cells harvested from nervous system tissues -Prepared samples for ELISA and Western Blot analysis -Regularly performed advanced animal research techniques such as perfusion, dosing, blood collection, and brain and spinal cord tissue collection -Received training in the care and handling of laboratory animals -Sterilized equipment and performed other basic lab maintenance as needed -Presented a formal research project and poster session based on this work -Collaborated on a project with a UW Medical Student which led to the development of a paper for publication Show less -Executed a wide variety of research procedures and projects in support of the Principal Investigator and several graduate students for a university laboratory -Performed various microbiology lab procedures such as RNA Isolation, cDNA Synthesis, and Real Time PCR -Responsible for preparing and maintaining culture plates of cells harvested from nervous system tissues -Prepared samples for ELISA and Western Blot analysis -Regularly performed advanced animal research techniques such as… Show more -Executed a wide variety of research procedures and projects in support of the Principal Investigator and several graduate students for a university laboratory -Performed various microbiology lab procedures such as RNA Isolation, cDNA Synthesis, and Real Time PCR -Responsible for preparing and maintaining culture plates of cells harvested from nervous system tissues -Prepared samples for ELISA and Western Blot analysis -Regularly performed advanced animal research techniques such as perfusion, dosing, blood collection, and brain and spinal cord tissue collection -Received training in the care and handling of laboratory animals -Sterilized equipment and performed other basic lab maintenance as needed -Presented a formal research project and poster session based on this work -Collaborated on a project with a UW Medical Student which led to the development of a paper for publication Show less