Scientific Leader, CMC Biosimilars

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.

For more information visit: www.apotex.com.

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 establishment, CQAs identification and criticality ranking, strategy for analytical similarity studies and evaluation methods
• Collaborate with analytical development teams to interpret analytical data and investigate process-related issues. Support review of data to demonstrate process comparability from a drug substance perspective.
• Support with other studies as applicable – extractables leachables studies, container closure selection and compatibility studies, transport validation etc.
• Work collaboratively with cross-functional teams within Apotex and the CMO (DS/DP process development, Analytical development, Manufacturing, Regulatory Affairs and Quality) to achieve project goals, ensuring alignment between sponsor expectations and CMO execution
• Contribute to generation / review of DS/DP process related documentation generated by CMO - including protocols, reports, specifications, batch records etc. for regulatory submissions
• Visit CMOs as needed for manufacturing readiness assessment and support and oversight for key milestones (optimization, tech transfer, validation, scale up etc.) during the biosimilar development
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Integrity, Courage, Teamwork, and Innovation.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education

• A Master's or Ph.D. in Biotechnology, Biochemistry, Biochemical Engineering, Pharmaceutical sciences or other related fields

• Knowledge, Skills and Abilities

• Knowledgeable and experienced in Biologics/Protein/Biosimilars development including upstream and downstream processes, DP formulation, aseptic fill/finish and container closure systems.
• knowledge of Design of Experiments, risk assessment, process modelling and statistical analysis
• Investigative & Analytical Mindset: Ability to analyse process and analytical data to understand the product and process.
• Strong foundation in protein chemistry, process, stability as well as analytical will be advantageous.

• Experience
  • Minimum 5-7 years in a regulated biopharmaceutical / biotechnological product development environment with experience in monoclonal antibodies or recombinant proteins.
  • Experience in biosimilars development by Leading technical interactions with CMOs and in driving process optimization initiatives to improve yield, reduce cost, and enhance process consistency

• Biosimilar development / manufacturing experience to support biopharmaceuticals projects at various stages from inception to regulatory approval and commercial launch.

• Knowledge of and practical experience with national and international regulatory requirements (Health Canada, FDA, EMA) as they relate to biopharmaceutical drugs in compliance with current Compendia, Pharmacopoeia, ICH and GMP requirements.

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

The hiring range for this position is $ 95,594.40- $ 133,832.16CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge, skills and experience.

We are looking for top talent. If your qualifications differ from those listed above, the scope of work and final agreed-upon salary may be adjusted to reflect your individual qualifications.

The Apotex Total Rewards package goes beyond base salary. Apotex offers bonus programs based on your position in the organization, you can excel based on our pay-for-performance philosophy. With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and professional development.

Apotex will use artificial intelligence to screen, select and/or assess your application for this job.

This job posting is for a role that is currently available and vacant at Apotex.