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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Job Summary
This role will be part of a high-performance team of scientific experts in Global R&D – Biosimilars & Specialty team, that works closely and in-depth with multiple global vendors in a virtual environment to deliver projects from inception to launch (co-development or in-licensing model).
He / She will be responsible for providing scientific expertise on Biosimilar Product Development focused on creating and optimizing manufacture and analysis of biologicals that are highly similar to already approved reference products. This role bridging R&D to commercial stage of development is responsible for ensuring the biosimilar achieves a high degree of similarity to the originator in terms of purity, potency, and safety as per global regulatory requirements.
The responsibility will include strategizing, leading and managing the activities of Biosimilar drug substance and drug product process development in collaboration with external Contract Manufacturing Organisations (CMOs). The incumbent will be a subject matter expert for biosimilar drug substance and drug product manufacturing, process characterization, process validation, technology transfer and scale up, ensuring quality, manufacturability, and regulatory compliance.
Additionally, the incumbent will work with other functional areas within Apotex - Project Management, Regulatory Affairs, External Supply Operation, and Quality areas to deliver projects and achieve milestones according to plan.
Job Responsibilities
- Working closely with the CMO to develop robust and consistent Drug Substance (DS) and Drug Product (DP) manufacturing process for Biosimilars; tracking and reporting progress, communicating development issues and providing input for resolution in a timely manner.
- Support development of DS and DP manufacturing processes (upstream and downstream), DP formulation and container closure systems - ensuring the biosimilar closely matches the critical quality attributes (CQAs) of reference biologic with comparability assessments, CQA monitoring and process adjustments as needed.
- Use Quality by Design principles to understand process-performance relationships. Support with identification of CQAs, definition of Critical Process Parameters, review of Risk assessments and Design of Experiments – to define process design space and control strategy.
- Scale-up & Technology Transfer:
Support Scale up of processes from laboratory to pilot and commercial scales and transfer these processes to CMO for clinical and commercial production. Support process characterization, process performance qualification and validation activities - ensuring compliance to current Good Manufacturing Practices and regulatory guidelines for biosimilar / biologic drug products. - Troubleshooting & Root Cause Analysis:
Support the CMO for Investigation of process deviations, troubleshoot manufacturing issues, and implement corrective/preventive actions to maintain product quality. - Develop strategies for biosimilar formulations, considering formulation or device or any other related intellectual property challenges using necessary formulation screening experiments, stability studies, biophysical characterization and other studies leading to stable biosimilar formulations
- Support the analytical similarity assessment in areas of Quality Target Product Profile…
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