Senior​/Process Scientist; f​/m​/d

Job Description

ABOUT THE ROLE

Join our MSAT Vaccines team as a technical process owner and project leader for vaccine Drug Product manufacturing. In this role, you will shape lifecycle and technology-transfer strategy, lead complex technical decisions across internal sites and CMOs, and translate science, process data, and cross-functional expertise into robust manufacturing performance, compliant execution, and reliable patient supply.

OBJECTIVES / PURPOSE

• Serve as technical process owner for assigned vaccine Drug Product (DP) processes across their lifecycle.
• Lead technology transfers, lifecycle management (LCM), PPQ, site-to-site transfers, and CMO-related initiatives.
• Define process strategies, manage technical risks, and ensure robust process performance, compliance, and supply continuity.
• Act as the primary MSAT technical point of contact for assigned sites, CMOs, and cross-functional teams.
• Drive scientific decision-making, process improvements, and successful project execution throughout the product lifecycle.

HOW YOU WILL CONTRIBUTE

• Own technical and scientific understanding of assigned DP processes, including control strategy, process validation, continued process verification (CPV), and lifecycle management.
• Lead technical investigations, root cause analysis, and resolution of complex process issues, deviations, and performance trends.
• Drive process robustness, continuous improvement, and risk-mitigation activities.

• Provide scientific leadership across relevant vaccine DP unit operations, including formulation, filling, lyophilization, visual inspection, single-use systems, aseptic processing, process validation, CPV, and control strategy, as applicable to assigned products.
• Lead or oversee process-fit and gap assessments, process risk assessments and pFMEA, process characterization, validation rationale, process monitoring, and transfer-readiness evaluations.
• Use statistical analysis, process data, digital systems, and AI-enabled tools to strengthen process understanding, identify risk signals, and support lifecycle decisions.

• Lead technology transfer, PPQ, NPI, line start-up, site transfer, and lifecycle management projects.
• Define project scope, timelines, risks, milestones, decision points, and technical deliverables.
• Ensure readiness for validation, transfer, and commercial manufacturing activities, including effective knowledge transfer and post-transfer stabilization.

• Serve as MSAT technical SPOC for assigned CMOs and manufacturing sites.
• Coordinate technical activities across Manufacturing, QA, QC, Regulatory, Engineering, Supply Chain, project teams, and external partners.
• Lead technical governance, issue resolution, escalation management, and decision preparation.

• Own or approve process-related technical documentation, transfer packages, technical reports, CPV strategies, APR inputs, process validation rationale, and regulatory filing support.
• Ensure activities comply with GMP, quality standards, regulatory expectations, and approved governance.

• Lead technical project and process decisions within approved governance for assigned products, processes, sites, and CMOs.
• Make or recommend decisions on process strategy, process-fit conclusions, technical risk acceptance, mitigation plans, PPQ and transfer readiness, process-change direction, documentation strategy, and escalation requirements.
• Escalate decisions with broader portfolio, regulatory, supply, resource, or product-team impact to the appropriate leadership or governance forum, providing a clear recommendation and scientific rationale.

WHAT YOU BRING TO TAKEDA

• Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Pharmaceutical Sciences, Life Sciences, or a related technical discipline.
• PhD is an advantage.

• Significant experience in vaccine or sterile Drug Product manufacturing within a GMP environment, with demonstrated accountability for technical process ownership or leadership of complex process‑science work streams.
• Proven expertise in technology transfer, process validation, PPQ, CPV, process risk management, change control, deviation and CAPA management, and complex process troubleshooting.
• Demonstrated experience leading cross‑functional technical teams and governance discussions in a matrix environment, including decision preparation, influence…