CMC Development Lead

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

Benefits offered by this job

Incentives program

Job summary

argenx is seeking a senior CMC leader to shape the development plan for multiple assets, ensuring alignment with clinical strategy and supply planning. You will lead a CMC team, collaborate with AST, and drive end-to-end program execution across drug substance and drug product realms.

The role requires an advanced life sciences degree with 10+ years in CMC, and a postgraduate business credential. You will engage with cross-functional teams, influence governance discussions, and advance

Qualifications

• Advanced life sciences degree; PhD preferred or Master’s 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

Stakeholder management

Cross-functional engagement

Team participation

Investigative mindset

Accountability

Education

PhD preferred; Master’s acceptable

Postgraduate degree in business administration

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.

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