Melanie Green

Drug Product Technician at Eurofins Alphora, Alphora Research Inc
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Contact Information
us****@****om
(386) 825-5501
Location
Milton, Ontario, Canada, CA

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Experience

    • Canada
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Drug Product Technician
      • Apr 2021 - Present

      • Execution of clinical trial GMP and non-GMP manufacturing of solid dose drug products• Formulation and process screening, Fill & Finish, micronizing, spray dryer dispersions• Completion of all documentation: executed batch records, logbooks, experimental summaries• Training of new team members in safety and compliance which resulted in zero lost time incidents.

    • Research Scientist II
      • Apr 2018 - Apr 2021

      • Planned and executed experiments for small molecule process development with focus on late-stage for validation purposes for New Drug Application filing• Part of team that led to FDA approval of a complex rare orphan drug, resulting in profit of $110M• Reduced costs by $700K with implementation of enhanced procedures and time savings of 50%• Prepared technical reports, process flow charts, project summaries for on time transfer of projects• Oversaw production scale-up of processes with batch observation and technical instruction• Member of workplace safety inspection team which resulted in reduction of workplace accidents Show less

    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • Research Associate III
      • 2017 - 2018

      • Conducted innovative process and technology experimentation for early development of new drug substance molecules utilizing Scifinder and patent literature searches which resulted in 5 patent applications. • Conducted innovative process and technology experimentation for early development of new drug substance molecules utilizing Scifinder and patent literature searches which resulted in 5 patent applications.

    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • Research Associate I, II
      • 2010 - 2016

      • Specialist in optimizing and streamlining processes for older generation small molecule projects• Developed new synthetic route for multimillion-dollar project reducing process costs by 40%• Strict organizational skills and attention to detail required for work on multiple projects at a time• Certified member of the JHSC: co-chair, worker representative, and hazard inspection team member.

    • Chemical Technician I
      • 2007 - 2010

      • Completed work on 9 processes with increased product output and reduced production costs• Executed qualifying lab batches and use-testing to ensure successful transfer to plant scale-up• Formulated complex GMP batch records and liaised with the Quality Assurance team to warrant compliance.

    • Belgium
    • Chemical Manufacturing
    • 700 & Above Employee
    • Laboratory Technician
      • 2006 - 2007

      • Quality testing to ensure continuous production to meet specifications and shipping deadlines • Onboarding of automated milling equipment to reduce ergonomic hazards in the laboratory • Implemented 5S principles in the Quality laboratories. • Quality testing to ensure continuous production to meet specifications and shipping deadlines • Onboarding of automated milling equipment to reduce ergonomic hazards in the laboratory • Implemented 5S principles in the Quality laboratories.

Education

  • Mohawk College
    Chemical Engineering Technology Diploma (Co-op), Chemistry
  • Niagara College
    Occupational Health and Safety Certificate Program, Health and Safety
    2022 - 2023
  • Food Industry Consulting
    Good Manufacturing Practices and Hazard Analysis and Critical Control Points Certificate, GMP and HACCP
  • Niagara College
    Health Science Preparatory Certificate, Chemistry and Biology

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