Biosimilars CMC Lead - DS/DP Process & Tech Transfer

APOTEX; Toronto; Vor Ort; CAD 96.000 - 134.000; Vollzeit

Benefits dieser Stelle

Bonus programs

Comprehensive benefits

Pension plan

Learning opportunities

Zusammenfassung

Apotex, a Canadian-based global health company headquartered in Toronto, seeks a Biosimilar Drug Substance/Drug Product Process Development lead. You will develop and optimize DS/DP manufacturing and analytical methods, and coordinate with CMOs to support biosimilar programs from inception to regulatory submission.

The role emphasizes DoE, CQAs, process validation, tech transfer, scale‑up, and GMP/regulatory compliance with Health Canada, FDA, and EMA.

Qualifikationen

• Minimum 5-7 years in a regulated biopharmaceutical product development environment.
• Experience with monoclonal antibodies or recombinant proteins.
• Knowledge of Health Canada, FDA, EMA regulatory requirements.
• Strong analytical and problem-solving mindset.
• Ability to lead tech transfer and scale-up with CMOs.

Aufgaben

• Develop DS/DP manufacturing processes in collaboration with CMOs.
• Characterize CQAs and design experiments to ensure comparability.
• Lead technology transfer from lab to pilot/clinical scales.
• Ensure GMP compliance and regulatory documentation.
• Support risk assessments and design of experiments.

Kenntnisse

Biosimilar development

Process development

Design of Experiments

Regulatory compliance

CQAs identification

Ausbildung

Master's or Ph.D. in Biotechnology/ Biochemistry/ Biochemical Engineering/ Pharmaceutical sciences

Jobbeschreibung

Apotex, a Canadian-based global health company headquartered in Toronto, seeks a Biosimilar Drug Substance/Drug Product Process Development lead. You will develop and optimize DS/DP manufacturing and analytical methods, and coordinate with CMOs to support biosimilar programs from inception to regulatory submission.

The role emphasizes DoE, CQAs, process validation, tech transfer, scale‑up, and GMP/regulatory compliance with Health Canada, FDA, and EMA.