Senior Director, MS&T, Biologics Platform

The Global Manufacturing Science and Technology (MSAT) organization is a network-focused function providing strategic direction and technical and operational leadership across a global manufacturing network.

MSAT serves as the steward of manufacturing process knowledge, ensuring alignment of commercial operations with registered processes and driving robustness, compliance, performance, and cost efficiency across the product lifecycle.

This role requires a highly blended technical leader with deep expertise spanning drug substance process development, scale-up, and commercial manufacturing, capable of bridging R&D, Process Development, and Manufacturing Operations within a global biologics network., Platform & Technology Leadership

• Accountable for biologics manufacturing technology platforms (MTTs), ensuring effective, scalable, and future-ready capabilities are in place to support evolving modalities
• Serve as the single point of accountability across MSAT for biologics platform strategy and execution
• Lead development, optimization, and industrialization of biologics platforms across drug substance manufacturing processes (upstream and downstream)

Drug Substance & Process Development Integration

• Drive strong integration between process development (early and late stage) and commercial manufacturing, ensuring seamless translation of processes from development through scale-up and into routine production
• Provide strategic oversight on process characterization, process robustness, and control strategy development for biologics drug substance
• Ensure incorporation of Quality by Design (QbD), process understanding, and lifecycle management across DS manufacturing processes
• Partner closely with R&D and Technical Development to ensure design-for-manufacturability and scalability are embedded early in development programs

Manufacturing & Commercial Operations Leadership

• Provide technical leadership and oversight to ensure commercial-scale manufacturing performance, reliability, and continuous improvement
• Support global manufacturing sites in process monitoring, deviation management, and sustained process verification
• Lead complex technical transfers (internal and external CDMOs) with a focus on robustness, speed, and compliance
• Drive global manufacturing excellence initiatives, including yield improvement, cycle time reduction, and cost optimization

Network & Execution

• Lead cross-functional and cross-site collaboration across MSAT, Manufacturing, Engineering, and Quality organizations
• Manage and develop a global team of biologics SMEs, ensuring capability build across upstream, downstream, and DS process disciplines
• Drive deployment of digital, modeling, and advanced analytics tools across biologics unit operations

Troubleshooting & Lifecycle Management

• Provide leadership in advanced technical troubleshooting, root cause analysis (RCA), and CAPA effectiveness
• Lead lifecycle management and continuous process improvement initiatives for commercial biologics products
• Ensure processes remain state-of-the-art across evolving modalities

Governance & Stakeholder Engagement

• Maintain strong engagement with R&D, Regulatory, Quality, and Supply Chain partners
• Ensure compliance with global regulatory expectations (FDA, EMA, and other regions)
• Uphold corporate governance, quality systems, and inspection readiness across the network

Do you have experience in Technology transfer (scale-up process)?, Do you have a Bachelor’s degree?, * BSc / MSc / PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, Pharmacy, or related fields

• PhD with 15+ years, MS with 18+ years, or BS with 20+ years of relevant experience

Core Experience Requirements

• Significant experience across process development, scale-up, and commercial manufacturing of biologics drug substance
• 7-10+ years of leadership experience managing technical teams across multiple sites and geographies

Technical Expertise

• Deep expertise in biology, drug substance manufacturing, including: *

• Upstream processing (cell culture, bioreactors, fermentation)
• Downstream purification (chromatography, filtration, viral clearance)

• Strong understanding of end-to-end process development through commercialization, including: *

• Process characterization and validation
• Technology transfer (internal and external)
• Control strategy development
• Extensive experience in large-scale GMP manufacturing environments
• Proven success in process scale-up and industrialization from clinical to commercial scale

Manufacturing & Operational Experience

• Demonstrated experience supporting or leading commercial manufacturing operations, including: *

• Continued process verification
• Deviation investigation and CAPA
• Manufacturing readiness and execution support

Large-Scale Experience

• Experience operating within large-scale pharmaceutical organizations or global CDMOs
• Proven ability to navigate complex, multi-site, global manufacturing networks
• Experience managing or interfacing with external manufacturing partners and outsourced production models

Additional Capabilities

• Strong knowledge of regulatory expectations (GMP, FDA, EMA)
• Experience in applying digital tools, modeling, and data analytics in biologics manufacturing
• Demonstrated leadership in structured problem solving and technical decision-making
• Strong communication and influencing skills across technical and executive audiences