Senior Scientist Downstream Processing

Job Summary

The Senior Scientist / Engineer, Downstream Manufacturing Technology, is responsible for leading downstream process technology transfers and supporting the successful introduction of new products at the Yverdon Bioplant. The role acts as a downstream process subject matter expert for GMP manufacturing, including facility fit assessments, plant modeling, process description definition, MES alignment, manufacturing support, troubleshooting, deviation investigation, process validation, and continued process verification. The position requires strong cross-functional collaboration with Production, Global Process Science, QA, QC, Engineering, and other key stakeholders to ensure robust, compliant, and scientifically sound downstream process implementation.

Technology Transfer and New Product Introduction

• Own and lead downstream process technology transfers for new products introduced at the Yverdon Bioplant.
• Assess facility fit, process scalability, equipment capability, and operational readiness for incoming downstream processes.
• Serve as the downstream subject matter expert during NPI implementation and ensure phase-appropriate process knowledge is transferred to Manufacturing.

Manufacturing Support and Troubleshooting

• Provide downstream process expertise to Production during GMP manufacturing campaigns.
• Lead technical troubleshooting for complex downstream process issues and define science-based actions in collaboration with relevant stakeholders.
• Lead or support major GMP investigations related to downstream process performance, deviations, and process-related events.

Documentation, Compliance, and Risk Management

• Ensure downstream process descriptions remain current, accurate, and aligned with manufacturing execution.
• Support and review MES master data and batch record configuration to ensure alignment with approved process descriptions.
• Own or contribute to DSP technology transfer reports, campaign reports, risk assessments, and process-related GMP documentation.
• Represent Manufacturing Technology in risk assessments in collaboration with Process Science, Production, QA, QC, and Engineering.

Continuous Improvement and Collaboration

• Lead process improvement initiatives to increase robustness, improve capacity, or reduce cost of goods.
• Maintain close interactions with Global Process Science teams in Yverdon and the US.
• Act as the operational and scientific referent for downstream process topics within the assigned scope.

Qualifications

Education and Experience

• MSc or equivalent degree in biotechnology, biochemistry, chemical engineering, pharmaceutical sciences, or a related scientific discipline.
• Significant experience in biopharmaceutical manufacturing, MSAT, process development, or technology transfer, preferably with downstream processing in a GMP environment.

Technical Expertise

• Strong scientific expertise in downstream manufacturing processes and associated equipment.
• Demonstrated ability to solve complex technical problems using a structured, data-driven, and scientific approach.
• Proficiency in statistical tools and data analysis, including DOE and multifactorial analysis.
• Experience with risk assessment methodologies such as FMEA.

GMP, Documentation, and Regulatory Knowledge

• Strong understanding of GMP requirements and relevant regulatory expectations for biopharmaceutical manufacturing.
• Ability to write clear, structured, and scientifically sound technical documentation.
• Ability to interpret scientific literature and apply relevant knowledge to process understanding and problem solving.
• Proven ability to contribute to investigations, change controls, validation documentation, and process performance assessments.

Leadership and Collaboration

• Ability to lead cross-functional troubleshooting and drive alignment on technical actions.
• Strong project and task prioritization skills.
• Collaborative mindset with the ability to work effectively with Production, QA, QC, Engineering, and Process Science.
• Demonstrated commitment to compliance, business integrity, and ethical behavior.