Senior Process Engineer, MSAT, Drug Substance

Amylyx Pharmaceuticals, Inc.; United States; On-site; 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

Role: Senior Process Engineer, MSAT, Drug Substance, providing technical and GMP leadership for late-stage peptide drug substance manufacturing at external CDMOs.

Responsibilities

lead technology transfer, process validation, continued process verification, investigations, change control, and lifecycle management of avexitide; support manufacturing operations, perform root cause analyses, ensure cGMP compliance, review regulatory documentation, and drive process improvements using QbD, DoE, and SPC.

Requirements

Bachelor's in chemical engineering or related field with 8+ years (or Master's with 5+ years) supporting late-phase/clinical peptide or biologic manufacturing, expertise in downstream operations (chromatography, ultrafiltration, lyophilization), deep knowledge of cGMP, validation, and regulatory standards; strong data analysis, communication, and external stakeholder influence skills.

Preferred

experience with peptide synthesis methods, modeling tools like MATLAB or JMP, and supporting regulatory submissions.

HighValue

peptide biologics, late-stage clinical or commercial manufacturing, process validation, technology transfer, investigations, risk assessments, and global regulatory compliance.

WorkSetup

remote within the US with travel up to 20% to Cambridge, MA; requires reliable remote working environment.