Danielle Lee

Regulatory Affairs Consultant

Melbourne, Victoria, Australia

About

Experience

  • ChemSkill Regulatory Affairs Consulting (Hybrid)
    • Regulatory Affairs Consultant
      Jun 2026 - Present · 2 mos

    • Regulatory Affairs Associate
      Jun 2025 - Present · 1 yr 2 mos

  • QA Document Control & Training Coordinator at IDT Australia Limited
    Jul 2024 - Jun 2025 · 1 yr

  • Quality Control Technician at Intraceuticals
    Feb 2023 - Jul 2024 · 1 yr 6 mos

    - Spearheaded daily QC processes, improving product compliance through meticulous testing of raw and bulk materials, ensuring that all analysed parameters met the specifications outlined in the Certificate of Analysis (CoA). - Implemented robust QC protocols, ensuring all products consistently met stringent GMP standards. - Performed daily calibration of laboratory equipment per SOPs and adhered to GLP standards, ensuring the accuracy and validity of test results. - Accurately reviewed and approved batch manufacturing records and finished goods against their respective CoAs to ensure product adherence to specifications.

  • Formulation Science Intern at Formulytica
    Aug 2023 - Nov 2023 · 4 mos

    - Developed the first stable microemulsion formulation, thereby contributing to the development and optimisation of a novel acne treatment product. - Synthesised comprehensive literature reviews, followed by accurate and efficient documentation of findings on LabArchives, supporting formulation strategies and innovation.

  • Masters Research Placement Student at Monash University
    Sep 2022 - Oct 2022 · 2 mos

    - Validated an LC-MS/MS assay in lymph to investigate the absorption of orally delivered constrained peptides, using quality control samples to ensure precision and accuracy of the assay. - Implemented advanced laboratory techniques including LC-MS/MS, HPLC, and cannulation whilst strictly adhering to GLP regulations and SOPs, ensuring compliance and reliability in experimental procedures. - Conducted precise data analysis using Microsoft Office applications and GraphPad Prism, followed by meticulous documentation of experimental results and methodologies, maintaining high standards of accuracy and comprehensive records to support research reproducibility.