Stephen Macleod Email & Phone Number

Toronto, On, Ca

Kitchener, On, Ca

San Francisco, California, Us

Princeton, New Jersey, Us

Toronto, Ontario, Ca

Edmonton, Alberta, Ca

Toronto, Ontario, Ca

- Performed testing and studies for Abbreviated New Drug Applications (ANDA's) or equivalent as required by various regulatory agencies in numerous regions (FDA, Health Canada, European Medicines Agency, etc.).- Studies executed include: photostability, stability under normal and stressed conditions, blend and final product content uniformity, solubility (including alcohol) studies.- Testing performed consisted heavily of Assay and/or Impurites by HPLC, and Dissolution (by UV or LC).- Performed method validations and revisions in preparation for transfer to Quality Control once product was approved and gone commercial. Performed method transfers.

Deerfield, Illinois, Us

- Sole Chemist responsible for ensuring all raw materials were released in a timely matter in a very high volume and lean pharmaceutical/medical device manufacturing facility.- Communicated with internal buyers, production planners, and production supervisors to prioritize tasks and ensure absolutely no production delays.- Ensured accuracy of raw material information and status in Oracle's JD Edwards, released material in JDE and our LIMS (Laboratory Information Management System) when reviewed.- Took on additional extracurricular work outside my role: validations of equipment and new laboratory construction, revisions on many SOP's, oversaw installation of two brand-new Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) units and ensured the installation qualifications corresponded to our validation protocols.- Performed daily water testing rotating through every point of use drop in the plant, to ensure suitability for sterile solution manufacturing as per United Stated Pharmacopoeia (USP).

Charlottetown , Pe, Ca

- Supervised a team of Chemists, worked 12.5-hour shifts around the clock.- Prioritized tasks, delegated work, and communicated heavily with other departments. Reviewed and released work completed by Chemists.- Dealt with any issues that arose, made final decisions when necessary on night shifts since no superiors were available.- Delivered annual performance reviews to Chemists under my supervision.- Trained Chemists under my supervision.- Worked on the bench when time would allow.

Charlottetown , Pe, Ca

- Worked 12-hour shifts around the clock in a fast-paced pharmaceutical lab, testing and releasing raw materials, in-process samples, and finished goods (Active Pharmaceutical Ingredients).- Hands-on experience with a wide range of equipment: Nuclear Magnetic Resonance (NMR), Ultra- and High-Performance Liquid Chromatography, (UPLC/HPLC), Gas Chromatography (GC), Ultraviolet–visible and Infrared spectroscopy (UV/IR), Karl Fisher Titrators (Volumetric, Coulometric, Auto-titrator).- Utilized corresponding software including Empower 2/3 for all chromatography.

Ottawa, Ontario, Ca