Job Title: Scientific Leader
Company: Apotex Inc.
Date: April 26, 2025
Location: North York, ON, CA, M9L 1T9
About Apotex Inc.:
Apotex Inc. is a Canadian-based global health company producing high-quality, affordable medicines for patients worldwide. With nearly 7,200 employees, the company operates in manufacturing, R&D, and commercial sectors. Its products are distributed in over 75 countries. Through vertical integration, Apotex focuses on the development and sale of generic, biosimilar, and specialty pharmaceutical products.
For more details, visit: www.apotex.com
Job Summary:
The Scientific Leader, Formulation Development Technical (Solid Dose) is responsible for developing and optimizing stable pharmaceutical formulations for commercial production. This includes guiding projects from early development milestones to final product launch, applying Quality-by-Design (QbD) principles, and ensuring compliance with regulatory requirements.
Key Responsibilities:
Lead the development and design of solid oral dosage formulations for new pharmaceutical products.
Conduct patent searches, review scientific literature, and recommend development strategies.
Coordinate procurement of APIs, excipients, and tooling for ongoing projects.
Work closely with plant operation supervisors and schedulers to execute experimental trials and registration batches.
Ensure timely documentation for all stages of product development and process optimization.
Apply QbD principles to evaluate formulation robustness and define control strategies.
Review and evaluate analytical data for formulation trials and recommend batches for bio/stability studies.
Collaborate with labs and documentation teams to generate required documents for scale-up and regulatory submissions.
Investigate formulation/process issues, identify root causes, and propose corrective actions.
Provide scientific consultation across departments and participate in regulatory deficiency responses.
Maintain up-to-date expertise in pharmaceutical formulation and manufacturing.
Adhere to all compliance policies, including GMP, GLP, GDP, Safety, FDA, and TPD standards.
Education Requirements:
Master’s degree or Ph.D. in Pharmacy, Pharmaceutical Technology, Chemical Engineering, or related sciences.
Skills and Abilities:
Strong theoretical and practical knowledge of various solid oral dosage forms (immediate, controlled, delayed release).
Proficiency in excipient properties and formulation development techniques.
Excellent communication and scientific writing skills.
Strong project management, organization, and interpersonal abilities.
Ability to work independently and make sound, accountable decisions.
Familiarity with Microsoft Office and laboratory systems.
Knowledge of applicable global regulations and quality standards.
Experience Required:
Minimum 5 years of experience in pharmaceutical formulation development, scale-up, or technology transfer, ideally in a development-focused environment.
Equal Opportunity and Accessibility:
Apotex is committed to creating an inclusive, accessible environment. Accommodations are available for candidates with disabilities during the recruitment process.
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