Senior Process Engineer, MSAT, Drug Substance

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

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.

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.

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

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

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