Biosimilar process development leadership at Apotex requires expertise in biological manufacturing, process characterization, and analytical similarity assessment. This role collaborates with global vendors virtually. As a Scientific Leader within Global R&D; – Biosimilars & Specialty, you will guide drug substance and drug product development. The work spans upstream and downstream processing, formulation, scale-up, technology transfer, and validation. You will help connect R&D; activities with commercial development while meeting regulatory requirements.

Key Responsibilities
- Lead biosimilar drug substance and drug product process development
- Collaborate with CMOs on manufacturing, troubleshooting, and corrective actions
- Define CQAs, critical process parameters, and control strategies
- Support scale-up, technology transfer, validation,



and regulatory documentation
- Interpret analytical data and assess process comparability

Requirements:
- Master’s or Ph.
D. in biotechnology, biochemistry, or related field
- Knowledge of biologics, proteins, biosimilars, formulation, and aseptic fill-finish
- Knowledge of Design of Experiments, risk assessment, and statistical analysis
- Five to seven years in regulated biopharmaceutical development
- Experience with monoclonal antibodies or recombinant proteins Apply scientific leadership in biosimilar manufacturing, process development, technology transfer, and comparability assessment at Apotex.

📌 Scientific Leader Biosimilar Process Development (Toronto)
🏢 Apotex
📍 Toronto