CMC Development Lead

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

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

Purpose of the Function

• Build the CMC Development plan in collaboration with the CMC Development team, ensuring alignment with the clinical development plan and clinical trial supply strategy
• Define long-term CMC strategy for specific assets or projects in line with the Target Product Profile (TPP)
• Provide leadership and facilitate communication between the Asset Strategy Team (AST)/project team and the CMC team

Reporting Line

Global Head of Technical Operations

Roles and 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 and Competencies

• Efficient communication skills
• Well-organized and proactive working style
• Ability to build effective relationships with internal and external stakeholders
• Strong engagement with the CMC development and project teams
• Active participation in cross-functional teams
• Investigative mindset to challenge decisions and timelines, driving development forward
• Accountability and proactive attitude

Education, Experience and 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

The annual base salary hiring range for this position is €100,000.00 - €137,500.00 EUR

This job is eligible to participate in our short-term and long-term incentives program.

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

argx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility.