Senior MSAT Process Engineer - Peptide Biologics (Remote)

Amylyx Pharmaceuticals, Inc.; United States; Remote; USD 140,000 - 210,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Process Engineer, MSAT, Drug Substance, to provide technical and GMP leadership for late-stage peptide drug substance manufacturing at external CDMOs.

You will lead technology transfer, process validation, continued process verification, investigations, change control, and lifecycle management of avexitide while supporting manufacturing operations and ensuring cGMP compliance. Strong data analysis and external stakeholder influence are essential.

Qualifications

• 8+ years in late-phase peptide/biologic manufacturing.
• Experience in downstream operations: chromatography, ultrafiltration, lyophilization.
• Strong knowledge of cGMP, validation, and regulatory standards.
• Excellent data analysis, communication, and external stakeholder influence.

Responsibilities

• Lead technology transfer and process validation.
• Oversee CPPs, investigations, change control, and lifecycle management of avexitide.
• Support manufacturing operations and perform root cause analyses.
• Apply QbD, DoE, and SPC to drive process improvements.

Skills

Downstream operations

QbD

DoE

SPC

Root cause analysis

Data analysis

Regulatory knowledge

Stakeholder management

Education

Bachelor's in chemical engineering

Master's in chemical engineering

Tools

MATLAB

JMP

Job description

Scorpion Therapeutics is seeking a Senior Process Engineer, MSAT, Drug Substance, to provide technical and GMP leadership for late-stage peptide drug substance manufacturing at external CDMOs.

You will lead technology transfer, process validation, continued process verification, investigations, change control, and lifecycle management of avexitide while supporting manufacturing operations and ensuring cGMP compliance. Strong data analysis and external stakeholder influence are essential.