Senior Downstream MSAT Engineer for Monoclonal Antibodies

Scholar Rock, Inc.; Cambridge (MA); Hybrid; USD 120,000 - 175,000; Full time

Job summary

Scholar Rock is seeking a Senior Engineer, Downstream MSAT, to lead monoclonal antibody downstream manufacturing across a global external manufacturing network. This role serves as the downstream process SME for commercial manufacturing, tech transfer, PPQ, CPV, investigations, change control, regulatory support, and lifecycle management.

The ideal candidate brings strong downstream biologics process expertise, GMP experience, and the ability to partner with CDMOs and internal teams.

Qualifications

• Experience with mAb downstream manufacturing in GMP environments.
• Strong knowledge of chromatography, viral filtration, TFF, UF/DF operations.
• Experience reviewing batch records and GMP documentation.
• Excellent communication and technical writing skills.

Responsibilities

• Provide downstream process oversight for late-stage clinical and commercial manufacturing at CDMOs.
• Act as Person-in-Plant for technology transfer, PPQ, and clinical/commercial activities.
• Provide technical support during manufacturing operations, including off-hours support when required.
• Own process monitoring systems, CPV programs, and manufacturing databases.
• Support APRs, PQRs, and lifecycle management activities.

Skills

Downstream manufacturing

GMP manufacturing

Technology transfer

Process validation

Technical writing

Education

PhD in Biochemical Engineering

MS in Chemical Engineering

BS in Biochemical Engineering

Tools

AKTA systems

Job description

Scholar Rock is seeking a Senior Engineer, Downstream MSAT, to lead monoclonal antibody downstream manufacturing across a global external manufacturing network. This role serves as the downstream process SME for commercial manufacturing, tech transfer, PPQ, CPV, investigations, change control, regulatory support, and lifecycle management.

The ideal candidate brings strong downstream biologics process expertise, GMP experience, and the ability to partner with CDMOs and internal teams.