Manager, Analytical R&D; Lab Automation

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

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Responsible for directing the staff and activities of Analytical Research & Development To develop testing methods for drug substance and drug product. Advices the Product development group in the development of products through a thorough understanding of the chemistry of molecules in products and its behaviour in different dynamic environments. Organizes, coordinates and oversees NPD process in the team-based environment, provides technical guidance to senior scientists/chemists, implements team-oriented approach from the earlier stages to completion of the project.

Evaluates technical data and decides on course of action during NPD process. Ensures quality of the newly developed analytical methods and regulatory submission documents. Reviews/approves new product specifications. Provides expert advice to Formulation Development Department on critical quality attributes such as stability, compatibility, dissolution, and solubility to optimise and facilitate formulation development. Establishes close working relationships with other Product Development departments to create an integrated research environment and to ensure timely completion of NPD related submission documents for RA.

Lends expertise to other areas within the Apotex organization. Assists Director in strategic planning, budgeting and staffing.

• Plans, organizes and oversees the activities in the Analytical R & D Team.
• Manage effective method development and validation activities in the area of lab automation
• Provide recommendations to the management on enhancing productivities by using advanced lab automation equipment.
• Reviews and approves regulatory submission and other technical reports generated by the Analytical Development Team. Ensures the quality of documentation and test results generated in the AD.
• Monitors the quality and productivity of the lab output to ensure that optimum levels are achieved. Makes recommendations to the Director for continuous improvement of lab operations.
• Coordinates AD lab activities with those of other Analytical units
• Liaises with the Formulation Development Department and provides input to the formula development process as related to drug product compatibility, stability and dissolution/drug delivery characteristics.
• Works closely with other units of Analytical Operations, provides expert advice to other members of the AO team.
• Liaises across the organization at all levels to provide an in-depth level of expertise.
• Makes presentations at the executive level to keep them current with research and project development.
• Liaises with relevant laboratories to ensure timely physical testing of pharmaceutical samples.
• Investigates, encourages and uses unique problem solving techniques to perform trouble-shooting on highly complex issues with respect to the stability of drug substances and drug products, compatibility of API and excipients, chromatographic methodology.
• Lends expertise to other Analytical groups for the resolution of more…