Director, Platform Technology - Global Tech Operations

Location:
Gaithersburg, MD (USA) | Hybrid:
Three days per week on-site

Key accountabilities

• Platform strategy and standards: Set the platform vision, engineering standards, and multi-year roadmap. Define process engineering operating envelopes (highs/lows, CPPs, equipment specifications, control strategies) with a clear engineering design basis. Publish reusable engineering templates and playbooks including platform process descriptions, P&, equipment specifications, utility requirements, tech transfer guides, and manufacturing technology standards.
• Facility integration: Establish design principles for process-facility interfaces (cleanroom classifications, HVAC requirements, utility capacities, material flow, equipment layouts) that enable platform technologies. Build comparability and "switch" strategies into platforms and facility designs to manage lifecycle changes with minimal disruption.
• Manufacturing and process leadership
  :
  Set enterprise standards and adoption plans for end-to-end processing, including facility design requirements and utility infrastructure. Define PAT/APC strategies, RTD models, steady-state verification, equipment-train configurations, and start-up/shutdown procedures aligned to global regulatory expectations and engineering best practice.
• Scale-up and execution
  :
  Guide piloting through commercial implementation with sound scale-up principles, equipment sizing, facility fit studies, and utility demand modeling. Quantify value, capture learnings, and embed them across the network.
• Facility readiness: Assess existing capabilities versus platform requirements; define retrofit strategies or greenfield specifications to enable deployment.
• Collaboration and governance
  :
  Co-create with CMC, Clinical, Regulatory, QA, Facilities Engineering, Project Engineering, and site leaders on process risk, equipment selection, facility design, and lifecycle strategies. Harmonize engineering practices and facility design standards across internal sites, CMOs, and acquisitions with clear governance, roles, and accountability. Maintain transparent communication, timely updates, and risk escalation across Global Tech Ops and Biologics leadership.
• Technology and site enablement: Lead site technology transfers, facility-fit assessments, utility definition, equipment installation and qualification protocols, and adoption of digital monitoring/decision tools. Where required, stand up process engineering capabilities (mass/energy balance modeling, equipment sizing methodologies, scale-up principles, process simulation).
• Building systems integration: Define requirements for HVAC, clean utilities, waste treatment, and automation infrastructure to support flexible manufacturing.
• Regulatory partnership: Co-author technical content for design control strategies, including process engineering rationale and facility design justification to enable post-approval flexibility. Prepare teams and sites for regulatory interactions and inspections with emphasis on process design rationale and facility compliance.
• Data-driven improvement: Establish standards for process data, equipment performance metrics, utility consumption tracking, and information needed for autonomous decision-making and engineering analysis. Define engineering KPIs and scorecards (e.g., equipment utilization, process capability indices, facility efficiency metrics) and run feedback loops to track adoption and impact.

• Core:
  Fed-batch and intensified mammalian bioprocessing, microbial fermentation
• Emerging:
  Nucleic acid therapies, antibody-drug conjugates, radio conjugates, viral and gene therapies, enzyme-produced biologics, protozoan fermentation

• Experience: 13+ years in biologics manufacturing with strong process engineering and/or facilities engineering background (or 10+ years with an advanced degree in Chemical Engineering, Mechanical Engineering, or related field)
• 7+ years in Process Engineering/Development with facility design exposure
  ; late-stage and commercial Pharma experience.
• Engineering expertise: Demonstrated experience in process scale-up, equipment specification and selection, P&t, mass/energy balance calculations, and facility design for biologics manufacturing.
• Intensified manufacturing: Recent, hands-on leadership implementing n-1 or n-1 perfusion and/or producing high-yield biologics with connected or continuous downstream in GMP manufacturing, with emphasis on process engineering and facility integration.
• Facility engineering: Experience with cleanroom design, utility systems (WFI, clean steam, HVAC), material flow optimization, and equipment layout for GMP.
• Regulatory: Proven authoring of technical sections and/or leading technical regulatory strategy focused on process design and engineering controls.
• Collaboration: Strong record of leading matrix teams and influencing across process development, facilities engineering, project engineering, and external partners/CMOs. Site engineering leadership background; validation…