CMC Development Lead
100000 € - 137500 € par annéeargenx
argenx seeks a CMC Development Lead to build chemistry, manufacturing, and controls strategies for drug development programs. The role involves leading cross-functional CMC teams, developing regulatory and manufacturing plans, and ensuring alignment with clinical development timelines for a pipeline of autoimmune disease treatments.
Responsibilities
- Develop scientific CMC strategy including regulatory approach, manufacturing process, formulation, and presentation for assigned programs
- Lead the CMC Development team for assigned projects with end-to-end oversight of all technical operations activities
- Facilitate communication between Asset Strategy Team, clinical teams, and CMC functions to ensure alignment
- Prepare and present strategic CMC recommendations to governance bodies for endorsement
- Conduct due diligence and assess CMC risks for potential external acquisition programs
Requirements
- PhD or Master's degree in life sciences
- Postgraduate degree in business administration
- Minimum 10 years of CMC experience in drug substance or drug product manufacturing
- Strong communication and stakeholder management skills
- Ability to lead CMC development teams and drive strategic initiatives
- Experience with regulatory strategy and manufacturing process development
Compensation: €100,000–€137,500 EUR base annually
L'offre d'emploi a été publiée il y a 3 jours
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