About Apotex Inc.
Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: .
Job Summary
Responsible for managing the staff and activities of AD-PLCM Lab. Organizes, coordinates and oversees the product development process in a team based environment, provides guidance to scientists/chemists, implements team-oriented approach for the early stages to project completion. Evaluates technical data and decides on the course of action during PLCM process. Responsible for the quality of the newly developed analytical methods as well as their validation to support the regulatory submission of new API source.
Ensures continual review of SOPs and documentation to meet current regulatory requirements. Establishes close working relationships with R&D and Commercial units to create an integrated research environment and to ensure timely completion of new API sources as related submission documents for RA. Lends expertise to other areas within the Apotex organization. Assists Director in strategic planning, budgeting and staffing.
Job Responsibilities
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