CMC Development Lead - Strategy & Execution

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

Benefits offered by this job

Incentives program

Job summary

argenx is building a biotech leadership role in Belgium to steer CMC development plans aligned with clinical strategies, while maintaining start-up roots in science and innovation. The role reports to the Global Head of Technical Operations and drives alignment with trial supply and regulatory expectations.

You will lead the CMC Development team across drug substance, drug product, analytics, supply, and regulatory, coordinating with AST and IDTs to advance multiple programs and strategic

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 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

Communication

Organizational skills

Stakeholder management

Cross-functional collaboration

Initiative and accountability

Education

PhD in life sciences (preferred)

Master’s degree in life sciences or related field

Postgraduate degree in business administration

Job description

argenx is building a biotech leadership role in Belgium to steer CMC development plans aligned with clinical strategies, while maintaining start-up roots in science and innovation. The role reports to the Global Head of Technical Operations and drives alignment with trial supply and regulatory expectations.

You will lead the CMC Development team across drug substance, drug product, analytics, supply, and regulatory, coordinating with AST and IDTs to advance multiple programs and strategic