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.

• 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.

• 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.