Global CMC Leader for Pharma Manufacturing & Strategy

Biopharma Careers; Mulhuddart; Hybrid; EUR 180,000 - 230,000; Full time

Job summary

Astellas, Dublin Plant, seeks a Senior CMC Leader to define and implement a globally aligned CMC strategy for assigned products. You will partner with EU, US, and Japan teams to drive manufacturability, supply reliability, and lifecycle lifecycle management.

The role requires strong leadership of cross-functional teams, deep regulatory knowledge, and robust financial acumen to optimize costs and ROI. This is a permanent, hybrid position with international travel requirements.

Qualifications

• Advanced degree in pharmaceutical sciences, chemistry, or engineering.
• Significant CMC experience across development and/or commercial operations.
• Significant Project and Product Management experience.
• Experience leading global, cross-functional matrix teams.
• Broad expertise in formulation, manufacturing, regulatory, and supply strategy.
• Experience with COGM optimization and lifecycle management.
• Strong business acumen including financial modelling and ROI evaluation.
• Knowledge of GMP and global regulatory requirements.

Responsibilities

• Define and implement an integrated global CMC strategy aligned with product strategy and priorities.
• Serve as primary CMC representative to governance bodies.
• Lead CMC updates for submission to governance and boards.
• Oversee formulation strategy including dosage form, stability, and lifecycle flexibility.
• Own COGM strategy including cost targets and optimization initiatives.
• Lead cross-functional CMC matrix team across EU, US, and Japan.
• Ensure timely regulatory submissions and supply readiness.
• Drive lifecycle management and process improvements for products.

Skills

CMC leadership

Cross-functional leadership

Strategic planning

Regulatory knowledge

Financial modelling

Global collaboration

Communication

Education

Advanced degree in pharmaceutical sciences, chemistry, or engineering

Job description

Astellas, Dublin Plant, seeks a Senior CMC Leader to define and implement a globally aligned CMC strategy for assigned products. You will partner with EU, US, and Japan teams to drive manufacturability, supply reliability, and lifecycle lifecycle management.

The role requires strong leadership of cross-functional teams, deep regulatory knowledge, and robust financial acumen to optimize costs and ROI. This is a permanent, hybrid position with international travel requirements.