Senior CMC Director

Walker Cole have partnered with a pioneering biotech organisation with a global presence to identify a Senior CMC Director. As the Senior CMC Director, you will own the lead asset and be responsible for it's development from PhII through to BLA submission.

The Senior CMC Director will be responsible for: 

• Be fully accountable for CMC strategy leading to successful BLA submission on lead candidate
• Oversight of all externalised manufacturing, analytical , and QC activities with CRO/CMOs across the US, EU, and Asia.
• Build and implement a CMC strategy for the early clinical phase portfolio.
• Establish a clinical supply network through external distribution partners

The successful Senior CMC Director will have: 

• Bachelor's, Masters, of PhD in relevant subject 
• At least 15 years of industry experience in Biologics CMC 
• Previous experience of taking assets through a BLA 

| BLA | MAA | CMC | Technical Operations | Biologic | Antibodies | ADC | conjugates | CMC | GMP | Senior CMC Director | VP | biopharmaceutical | PhIII | phase 3 | PhII |