Manager, Analytical R&D

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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The Mass Spectrometry Group Manager leads the staff and operations within Analytical Development responsible for all mass‑spectrometry–based studies, special investigations, and analytical support for new product development, global regulatory submissions and commercial products. This role oversees all LC‑MS and GC-MS projects and testing activities, ensuring scientific excellence, regulatory compliance, and alignment with project and organizational goals. The manager provides technical leadership to scientists and senior chemists in developing and validating new LC‑MS and GC‑MS methods for pharmaceutical analysis.

They guide the team in conducting complex investigations, including structural elucidation and identification of related substances and degradation products in drug substances and drug products. Acting as a site-wide and cross‑functional expert, the Mass Spectrometry Group Manager consults with other departments and affiliated organizations on MS‑related challenges, offering strategic problem‑solving and advanced technical insight to support quality, development, and regulatory needs.

• Serve as an expert technical specialist within the Product Development organization, providing advanced scientific leadership in mass spectrometry.
• Guide scientific leader, directing them in development, implementation, and application of complex MS methodologies to support product development and regulatory requirements.
• Lead all mass spectrometry projects and investigations within Analytical Development (AD), ensuring scientific rigor, compliance, and timely execution.
• Function as an internal subject matter expert, offering technical consultation and project support, including oversight of external research and service providers.
• Recommend the selection and engagement of external partners for mass spectrometry–related research or analytical services.
• Manage across analytical research and development team to develop and execute strategies that resolve complex technical challenges in identification and peptide development.
• Leads organization at scientific forums, conferences, and professional associations as an authority in mass spectrometry and peptide development.
• Guide scientist to design and develop MS‑compatible LC / GC methods and perform LC/GC/MS and LC/GC/MS/MS analysis for drug substances and drug products, including nitrosamine impurities, genotoxic impurities, peptides, and other critical analytes.
• Guide scientists to conduct structural elucidation and identification of unknown impurities using MS/MS data, scientific literature, and other analytical tools.
• Approve comprehensive structure‑elucidation and investigation reports based on mass spectrometry and supporting analytical data.
• Design, implement, and maintain LC/MS and GC/MS system qualification procedures, including maintenance, operational qualification (OQ), and performance qualification (PQ) in alignment with manufacturer requirements.
• Provide technical guidance, training,…