Strategic CMC Development Lead for Immunology Programs

argenx US; Oost-Vlaanderen; On-site; EUR 100,000 - 138,000; Full time

Benefits offered by this job

Incentives program

Equal opportunity employer

Job summary

argenx is seeking a senior leader to build and drive the CMC Development plan across drug substances and products, aligning with clinical and trial supply strategies. You will lead a multidisciplinary team, coordinate with Asset Strategy and regulated governance, and shape long-term CMC plans for multiple projects.

The role emphasizes proactive stakeholder management, strategic communication, and external collaboration to advance a robust development program in a fast-growing biotech environment.

Qualifications

• Advanced degree in life sciences (PhD preferred; Master's acceptable)
• Postgraduate degree in business administration

Responsibilities

• Develop the scientific CMC strategy (regulatory strategy, manufacturing process, formulation, and presentation development) and translate into a CMC project plan with support from the CMC project manager
• Lead the CMC Development team for assigned projects/assets, maintaining end-to-end oversight and acting as the CMC representative for TechOps activities (drug substance, drug product, analytical, supply, CMC regulatory)
• Participate in AST team and development discussions
• Ensure proactive two-way communication with stakeholders (CMC Development team, Clinical Trial Supply, Asset AST, IDTs)
• Prepare and present strategic CMC discussions for endorsement at governance bodies
• Collaborate with cross-functional teams to evaluate external assets and align with internal strategies
• Support due diligence for potential new external programs, including CMC risk assessment

Skills

Efficient communication

Well-organized

Relationship building

Cross-functional collaboration

Engagement with teams

Investigative mindset

Accountability

Education

PhD in life sciences

MBA or postgraduate business degree

Job description

argenx is seeking a senior leader to build and drive the CMC Development plan across drug substances and products, aligning with clinical and trial supply strategies. You will lead a multidisciplinary team, coordinate with Asset Strategy and regulated governance, and shape long-term CMC plans for multiple projects.

The role emphasizes proactive stakeholder management, strategic communication, and external collaboration to advance a robust development program in a fast-growing biotech environment.