Biological drug substance and drug product manufacturing
Process characterisation and validation
A senior scientist CMC plays a key role supporting Chemistry, Manufacturing and Controls (CMC) development of Argenx drug products, ensuring that projects move forward in time and within budget
Job Summary
A senior scientist CMC plays a key role supporting Chemistry, Manufacturing and Controls (CMC) development of Argenx drug products, ensuring that projects move forward in time and within budget.
Drives the execution of CMC activities for early and late phase drug development candidates and changes to validated commercial processes.
A work environment in a human-sized, dynamic and rapidly growing biotech company.
Matching Summary
A senior scientist CMC plays a key role supporting Chemistry, Manufacturing and Controls (CMC) development of Argenx drug products, ensuring that projects move forward in time and within budget.
Skills & Requirements
Must-have
GMP knowledge and experience
Biological drug substance and drug product manufacturing
Process characterisation and validation
ICH and GMP regulations knowledge
Regulatory submission preparation
Nice-to-have
Creative problem solving
Independent literature search
Flexible and quality conscious attitude
Human-sized dynamic company environment
Key Requirements
PhD in chemistry, pharmaceutical sciences, bio-engineering