Melanie Leland
Quality Technician at Particle Dynamics- Claim this Profile
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Bio
Experience
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Particle Dynamics
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Quality Technician
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Oct 2022 - Present
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Eurofins PSS Insourcing Solutions
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Analytical Method Development Scientist
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Feb 2022 - Oct 2022
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Catalent Pharma Solutions
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Scientist Quality Control Cleaning Validation
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Apr 2020 - Dec 2021
Responsibilities include method validation for cleaning validation and verification samples, testing of routine and on-demand cleaning validation and verification samples for TOC and Conductivity, feasibility testing for new residues, protocol writing, report writing, periodic SOP review and revision, peer notebook review, periodic change requests and analyst training. Responsibilities include method validation for cleaning validation and verification samples, testing of routine and on-demand cleaning validation and verification samples for TOC and Conductivity, feasibility testing for new residues, protocol writing, report writing, periodic SOP review and revision, peer notebook review, periodic change requests and analyst training.
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Kremers Urban Pharmaceuticals Inc.
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Technical Transfer Chemist
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Feb 2016 - Apr 2020
Responsibilities include Method transfers and method validations for analytical testing of finished products, cleaning validations and raw materieals. Evaluation of Compendial methods, Evaluation of new materials, Equivalency testing, Method verification, and Method Suitability of Use. Analytical support for marketed products including method development, method transfers, method validation, cleaning validation. Life cycle evaluation and maintenance of methods for marketed products and investigational testing support of Deviations and LIRs. Analytical methods include wet chemistry techniques, dissolution, UV-Vis, TOC, HPLC and Gas Chromatography. Responsibilities also include protocol writing, report writing, periodic SOP review and revision, peer notebook review, periodic change requests and analyst training. Show less
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Analytical Services Chemist
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Sep 2014 - Feb 2016
Responsibilities include Evaluation of Compendial methods, Evaluation of new materials, Equivalency testing, Method verification, and Method Suitability of Use. Analytical support for marketed products including method development, method transfers, method validation, cleaning validation, excel spreadsheet development and validation, Life cycle evaluation and maintenance of methods for marketed products and investigational testing support of Deviations and LIRs. Analytical methods include wet chemistry techniques, dissolution, UV-Vis, TOC, HPLC and Gas Chromatography. Responsibilities also include protocol writing, report writing, periodic SOP review and revision, peer notebook review, periodic change requests and analyst training. Show less
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Analytical Development Chemist
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May 2003 - Sep 2014
Responsibilities include method development, method transfers, method validation, cleaning validation, excel spreadsheet development and validation and investigational testing support of Research and Development. Analytical methods include wet chemistry techniques, dissolution, UV-Vis, TOC, HPLC and Gas Chromatography. Responsibilities also include protocol writing, report writing, periodic SOP review and revision, peer notebook review, periodic change requests and analyst training.
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Education
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University of Toledo
Bachelor of Science (B.S.), Chemistry -
University of Toledo
Associates degree, Retail Management