Melanie Green
Drug Product Technician at Eurofins Alphora, Alphora Research Inc- Claim this Profile
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Bio
Experience
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Eurofins CDMO Alphora Inc.
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Canada
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Drug Product Technician
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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.
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Research Scientist II
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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
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Apotex Pharmachem Inc.
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Research Associate III
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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.
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Apotex Pharmachem Inc.
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Research Associate I, II
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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.
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Chemical Technician I
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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.
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Umicore
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Belgium
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Chemical Manufacturing
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700 & Above Employee
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Laboratory Technician
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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.
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Education
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Mohawk College
Chemical Engineering Technology Diploma (Co-op), Chemistry -
Niagara College
Occupational Health and Safety Certificate Program, Health and Safety -
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