Senior Engineer II, Downstream Manufacturing Science & Technology (MSAT)

Scholar Rock is seeking a Senior Engineer II, Downstream Manufacturing Science & Technology (MSAT), to provide technical leadership for monoclonal antibody downstream manufacturing across a global external manufacturing network. This role serves as the downstream process SME supporting commercial manufacturing, technology transfer, PPQ/process validation, CPV, investigations, change control, regulatory support, and lifecycle management.

The ideal candidate brings strong downstream biologics process expertise, significant GMP manufacturing experience, sound technical judgment, and the ability to partner effectively with CDMOs and internal Process Development, External Manufacturing, Quality, Regulatory, and Supply Chain teams. This role is expected to influence cross-functional decision-making and serve as a trusted technical partner across downstream manufacturing activities.

Position Responsibilities

External Manufacturing Support:

• • Provide downstream process oversight for late-stage clinical and commercial manufacturing at CDMOs, including campaign readiness, technical risk assessment, manufacturing planning, and execution support.
  • Serve as Person-in-Plant, as needed, for technology transfer, PPQ/process validation, and clinical/commercial manufacturing activities.
  • Provide timely technical support during critical manufacturing operations, including off-hours support when required.

  Process Monitoring & Lifecycle Management:

  • • Own and maintain process monitoring systems, manufacturing databases, lot histories, and CPV programs.
    • Analyze manufacturing performance through statistical trending and process monitoring tools to ensure processes remain in a state of control.
    • Support Annual Product Reviews (APRs), Product Quality Reviews (PQRs), and ongoing commercial lifecycle management activities including post-approval changes and continuous improvement initiatives.

    Technology Transfer & Validation:

    • • Collaborate with Process Development teams to ensure effective transfer of process knowledge into GMP manufacturing operations.
      • Support or lead process characterization, process performance qualification (PPQ), and process validation activities.
      • Contribute to generation and execution of validation protocols, validation reports, and associated technical documentation.

      Investigations, Change Control & Technical Leadership:

      • • Lead or support deviations, atypical results, process excursions, change controls, technical/risk assessments, CAPAs, and issue resolution for downstream manufacturing processes.
        • Present technical analyses, manufacturing trends, and process performance updates to cross-functional teams and leadership.

        Documentation & Regulatory Support:

        • • Review and author GMP manufacturing documentation, batch records, technical reports, , and regulatory submission content.
          • Support health authority responses, post-approval changes, inspections, and regulatory interactions as the downstream process SME.
          • Author technical assessments, risk assessments, manufacturing support documents, and process monitoring reports.

Candidate Requirements

• Bachelor’s, Master’s, or PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, or a related discipline, with relevant MSAT, process engineering, GMP manufacturing, technology transfer, or biologics manufacturing experience.
• BS with 10+ years, MS with 8+ years, or PhD with 2 - 5 years of relevant experience.
• Experience supporting mAb downstream manufacturing processes in a GMP environment.
• Strong knowledge of chromatography, viral filtration, TFF, and UF/DF operations.
• Experience reviewing batch records, GMP manufacturing documentation, and technical reports.
• Strong communication, organization, collaboration, and technical writing skills.

Preferred Qualifications

• Experience with commercial biologics manufacturing, CPV/APR/PQR, technology transfer, PPQ/process validation, deviation investigations, CAPA, change control, regulatory support, CDMO oversight, JMP/statistical trending, DoE, or process characterization.
• Experience with AKTA systems or lab-scale downstream development is desirable but not required.
• Travel: Approximately 25% travel to support technology transfer, process validation, commercial manufacturing, and external manufacturing partners.