Biologics CMC Lead – Biosimilars Development

Apotex Inc.; Toronto; Sur place; CAD 96 000 - 134 000; Plein temps

Avantages offerts par ce poste

Bonus programs

Pension plan

Learning and development opportunities

Résumé du poste

Apotex Inc. is seeking a senior biologics development professional to lead biosimilar DS/DP process development with CMOs, driving DoE-based optimization and scale-up activities to meet regulatory requirements.

The role focuses on process development, analytical similarity assessment, and cross-functional collaboration to deliver high-quality biosimilar products in a GMP environment at Apotex.

Qualifications

• Knowledge of biologics/biosimilars development including upstream and downstream processes.
• Understanding of Design of Experiments (DoE) and risk assessment.
• Experience with process modelling and statistical analysis.

Responsabilités

• Develop DS/DP manufacturing processes with CMOs (upstream and downstream).
• Apply Quality by Design to define CPAs and control strategies.
• Lead scale-up and tech transfer to pilot and commercial scales.
• Troubleshoot deviations and implement corrective actions.
• Develop biosimilar formulations considering IP and device challenges.
• Support analytical similarity assessments and CQAs.
• Collaborate with Analytical Development, Regulatory, Manufacturing, and Quality teams.
• Prepare DS/DP process documentation for regulatory submissions.
• Visit CMOs for manufacturing readiness and oversight of milestones.
• Maintain safety and comply with all policies.
• Demonstrate company values and ethics.

Connaissances

Biologics Development

DoE

Risk Assessment

Process Modelling

Statistical Analysis

Protein Chemistry

Formation

Master's or PhD in Biotechnology/ Biochemistry/ Biochemical Engineering/ Pharmaceutical sciences or related field

Description du poste

Apotex Inc. is seeking a senior biologics development professional to lead biosimilar DS/DP process development with CMOs, driving DoE-based optimization and scale-up activities to meet regulatory requirements.

The role focuses on process development, analytical similarity assessment, and cross-functional collaboration to deliver high-quality biosimilar products in a GMP environment at Apotex.