CMC Development Lead - Strategic CMC & Global Programs

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

Benefits offered by this job

Short-term incentives

Long-term incentives

Job summary

argenx SE is seeking a senior leader to shape the CMC development plan and strategy for multiple drug programs. You will align CMC with clinical and trial supply plans, lead the CMC Development team, and drive end-to-end oversight across drug substance, drug product, analytics, and regulatory activities.

You will coordinate with Asset Strategy Teams and cross-functional partners to ensure robust development plans, risk assessment, and timely governance discussions, contributing to the 2030

Qualifications

• Advanced degree in life sciences (PhD preferred; Master’s degree acceptable).
• Postgraduate degree in business administration.
• Minimum 10 years of CMC experience in drug substance and/or drug product manufacturing.

Responsibilities

• Develop the scientific CMC strategy (regulatory strategy, manufacturing process, formulation, and presentation development) and translate it into a CMC project plan with support from the CMC project manager for one or more drug development programs/projects
• Lead the CMC Development team for assigned projects/assets, maintaining end-to-end oversight and acting as the CMC representative for all TechOps activities (drug substance, drug product, analytical, supply, CMC regulatory)
• Actively participate in AST team and overall development discussions
• Ensure proactive two-way communication with all relevant stakeholders (CMC Development team, Clinical Trial Supply, Asset AST, and Integrated Development Teams)
• Prepare and present strategic CMC discussions for endorsement at CMC or AST governance bodies
• Collaborate with cross-functional teams to evaluate external assets and ensure alignment with internal development strategies and standards
• Support, coordinate, and conduct due diligence activities for potential new external programs, including assessment of CMC risks, opportunities, and integration requirements

Skills

Efficient communication

Well-organized working style

Relationship building

Stakeholder engagement

Cross-functional collaboration

Timelines and decision driving

Accountability

Education

PhD in life sciences

MBA / business degree

10+ years CMC experience

Job description

argenx SE is seeking a senior leader to shape the CMC development plan and strategy for multiple drug programs. You will align CMC with clinical and trial supply plans, lead the CMC Development team, and drive end-to-end oversight across drug substance, drug product, analytics, and regulatory activities.

You will coordinate with Asset Strategy Teams and cross-functional partners to ensure robust development plans, risk assessment, and timely governance discussions, contributing to the 2030