Summary
Overview
Work History
Education
Timeline
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Kaitlyn Michaud

Richmond,VA

Summary

Precise and motivated professional with 6 years of experience in the CRO realm. I'm a consistent high-performer who excels at communicating with peers, superiors, clients, and vendors.

Overview

6
6
years of professional experience

Work History

Senior Scientist

Thermo Fischer Scientific
08.2024 - Current
  • Senior administrator (1 of 3 individuals) responsible for review, approval, and maintenance of all electronic documentation bench sheet templates for all of Vaccine Sciences Department (VSD) approximately 1800+ procedures for both client specific methodology and general preparations.
  • Strategic planning and timeline management for internal product development, focused on feature prioritization and change management.
  • Cross-functional collaboration with other departments to assess process performance indicators and provide solutions that improve quality, efficiency, and transparency using Power BI and dashboards.
  • Responsible for training senior leadership across departments on electronic systems that will be deployed globally.

Scientist

PPD, Part of Thermo Fischer Scientific
02.2021 - 08.2024
  • Co-head of VSD Operations and Logistics Team, with a focus in database management, calibration failure investigations, and collaboration with QA, Technical Support, IT, and other departments as it pertains to equipment maintenance, process improvement, and deviations from governing protocols.
  • Lead author for equipment SOPs, as well as point of contact for over-arching quality event deviations from non-client specific SOPs within VSD.
  • Cross-trained on HL60 cell line procedures.
  • Provides new hire training for electronic systems used within VSD.

Associate Scientist

Pharmaceutical Product Development (PPD)
10.2019 - 02.2021
  • Qualified to perform a complex bioanalytical functional assay for 5 clients with consistent high quality data and low rate of method deviations.
  • QC Lead for client projects, responsible for organizing and ensuring timely execution of review.
  • Review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications.
  • Cross-trained on Hamilton liquid-handling system automated procedures, including program execution and daily, weekly, and monthly maintenance of robotics.
  • Selected by senior management (1 of 3 individuals) to relocate to Suzhou, China for a 2 year contract to establish functional assays at the new laboratory location due to Covid-19 pandemic, this project was cancelled.
  • Co-founder of Automated Systems Solution Enhancement Team (ASSET), a group dedicated to the development of trending tools, dashboards, and querying of various relational databases with a focus on SQL.

Assistant Scientist

Pharmaceutical Product Development (PPD)
07.2018 - 10.2019
  • Qualified to perform a complex bioanalytical functional assay for 3 clients with consistent high quality data and low rate of method deviations.
  • Trained within SOP requirements on how to navigate the appropriate channels to edit and receive approval for electronic bench sheet documentation.
  • Performed routine operation and maintenance of analytical instrumentation and standard laboratory equipment.
  • Review of electronic documentation and resulting assay data in comparison with SOP acceptance criteria, methodology, protocol and product specifications.
  • Preparation of reagents and performance of complex sample dilution schemes, with accurate traceability of freeze/thaw tracking and cataloging of sample locations.

Education

B.S. - Biological Sciences

Virginia Tech
Blacksburg, VA
05-2018

Timeline

Senior Scientist

Thermo Fischer Scientific
08.2024 - Current

Scientist

PPD, Part of Thermo Fischer Scientific
02.2021 - 08.2024

Associate Scientist

Pharmaceutical Product Development (PPD)
10.2019 - 02.2021

Assistant Scientist

Pharmaceutical Product Development (PPD)
07.2018 - 10.2019

B.S. - Biological Sciences

Virginia Tech
Kaitlyn Michaud