Job Description Summary

Job Description

Major Accountabilities

Organizational Leadership

• Establish a world-class Process Science CoE supporting all biologics manufacturing platforms.
• Develop technical roadmaps for improvement in fed-batch, intensified and continuous manufacturing technologies.
• Drive harmonization of scientific standards, best practices and technical governance across all manufacturing sites.
• Establish the CoE as the central knowledge hub for drug substance manufacturing processes.

Scientific & Technical Leadership

• Provide end-to-end technical oversight of upstream and downstream manufacturing processes.
• Serve as global SME for commercial biologics process performance, process characterization and process robustness.
• Lead scientific assessment of process performance trends, process capability and manufacturing excellence initiatives.
• Provide governance for complex technical investigations, atypical events and major product-impact assessments.
• Drive deployment of advanced process control strategies and data-driven manufacturing approaches.

Manufacturing Support

• Ensure timely scientific support for routine commercial manufacturing.
• Act as escalation point for critical manufacturing issues, deviations, and product impact assessments.
• Lead complex technical investigations and root cause analyses.

Process Lifecycle Management

• Own lifecycle management of commercial manufacturing processes.
• Drive process robustness, yield improvement, productivity enhancement, and cost optimization initiatives.
• Ensure effective Continued Process Verification (CPV) and process monitoring programs.

Technology Transfer

• Support/Lead transfers of commercial and development products into and out of the site.
• Ensure effective transfer of process knowledge, control strategies, and manufacturing expertise.
• Establish risk-based transfer plans and governance structures.

Validation and Compliance

• Provide technical leadership for process characterization, PPQ, comparability and validation lifecycle activities.
• Support global regulatory submissions and agency interactions.
• Maintain inspection readiness across the manufacturing network.
• Provide scientific justification and technical defense during regulatory inspections.

Innovation & Emerging Technologies

• Evaluate emerging manufacturing technologies and industry trends.
• Drive adoption of advanced analytics, digital twins, AI-enabled manufacturing and predictive process monitoring.
• Build partnerships with equipment suppliers, technology providers and academic institutions.
• Sponsor innovation programs improving manufacturing flexibility, robustness and cost competitiveness.

People Leadership

• Lead and develop global Process Science leaders and subject matter experts.
• Build organizational capability in USP, DSP and continuous manufacturing.
• Establish succession planning and talent pipelines.
• Foster a culture of scientific excellence, collaboration, innovation and accountability.

Stakeholder Management

• Serve as technical representative to Global MS&T, Regulatory Affairs, Quality, Supply Chain, and Manufacturing Operations.
• Lead technical governance forums and cross-functional decision-making processes.

Competencies

Leadership Competencies

• Strategic Leadership
• Scientific Excellence
• Business Acumen
• Stakeholder Management
• Organizational Development
• Change Leadership
• Talent Development
• Decision Making
• Innovation Mindset
• Continuous Improvement

Key Performance Indicators

Supply & Manufacturing Excellence

• Supply reliability (% batches released / no supply interruptions)
• Right-First-Time (RFT) manufacturing rate
• Process yield achievement
• Process capability (CpK/PpK) for critical processes

Quality & Compliance

• Critical/major inspection observations
• Overdue deviations and CAPAs
• Recurring deviation rate
• Products maintained in validated state

Lifecycle & Technical Delivery

• Technology transfers delivered On-Time-In-Full (OTIF)
• Process validation / CPV milestones achieved
• Lifecycle change implementation success rate
• Technical project milestone adherence

Continuous Improvement

• Yield, throughput, or productivity improvements delivered
• Cost savings/value generation from process improvements
• Digital/PAT implementation milestones achieved

People & Organization

• Employee engagement score
• Talent retention and succession readiness
• Training compliance

Ideal Background

Education Minimum

• MSc in Biotechnology, Biochemical Engineering, Pharmaceutical Sciences, Chemical Engineering, Biology, or related scientific discipline

Preferred

• PhD in relevant scientific discipline

Languages

• Fluent English (written and spoken)

Experience Minimum

• 15+ years in Biologics Manufacturing, MS&T, Process Development, or Technical Operations
• 7+ years leading technical organizations
• Experience supporting commercial biologics manufacturing
• Deep expertise in upstream and/or downstream processing
• Proven technology transfer leadership experience
• Experience supporting regulatory inspections

Preferred

• Continuous manufacturing experience
• Perfusion manufacturing experience
• Advanced process control and PAT experience
• Global network leadership experience
• Multi-site manufacturing support experience

Skills Desired