Senior Director, CMC
Amylyx Pharmaceuticals(11 days ago)
About this role
Senior Director, Chemistry, Manufacturing, and Controls (CMC) at Amylyx will lead the CMC organization to advance the company’s clinical-stage pipeline (including Avexitide and AMX0114). The role oversees development of robust, scalable processes with external CDMOs to support clinical and commercial supply and ensures CMC readiness across programs. This leader reports to the SVP, Global CMC and External Manufacturing and partners cross-functionally to align CMC strategy with program goals.
Required Skills
- Process Development
- CMC Strategy
- Regulatory Submissions
- cGMP Compliance
- Tech Transfer
- CDMO Management
- Peptide Chemistry
- Oligonucleotide Chemistry
- Analytical Development
- Leadership
+2 more
Qualifications
- Advanced Degree in Chemistry, Chemical Engineering, or Related Field
About Amylyx Pharmaceuticals
amylyx.comAmylyx is a biopharmaceutical company focused on developing treatments for progressive neurodegenerative diseases. Its lead therapy, AMX0035 (marketed as Relyvrio), is a combination treatment for ALS designed to protect neurons by targeting mitochondrial and endoplasmic reticulum dysfunction. Amylyx advances a pipeline testing similar neuroprotective approaches in other neurological disorders and runs clinical trials to generate patient-centered evidence. The company emphasizes translational research, regulatory engagement, and partnerships with patients and clinicians to bring new therapies to market.
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