Director, Manufacturing Platform Technology – Global Tech Ops

Role Summary

Director of Manufacturing Platform Technology – Global Tech Ops, based in Gaithersburg, MD with hybrid work—approximately three days per week in the office. Leads the strategic development and establishment of manufacturing technology/equipment platforms across biologics and new modalities, directing a cross-functional team and providing operational support to the global technical network and key partnerships. Focuses on platform vision, standards, roadmaps, and enabling scalable, inspection-ready platforms across internal sites and CMOs.

Responsibilities

• Lead a matrixed, cross-functional team to shape and scale manufacturing technology/equipment platforms across biologics and new modalities; partner with Development, Operations, Quality, Regulatory, and external manufacturers to deliver robust, flexible, and inspection-ready platforms.
• Enterprise impact: Set platform vision, standards, and roadmap; accelerate continuous manufacturing adoption; harmonize ways of working across internal sites and CMOs to improve speed, reliability, and cost to serve.
• Platform Strategy And Standards: Define operating envelopes, critical process parameters, and control strategies for unit operations; publish platform process descriptions, tech transfer playbooks, and manufacturing technology standards; build comparability and switch strategies to manage lifecycle changes with minimal disruption.
• Modalities In Scope: Core technologies (fed-batch, intensified, microbial fermentation, continuous mammalian bioprocessing) and emerging modalities (nucleic acid therapies, ADCs, radioconjugates, viral and gene therapies, enzyme-produced biologics, protozoan fermentation).
• Continuous Manufacturing Leadership: Set enterprise standards and adoption plan for end-to-end continuous processing; define PAT/APC, residence-time distribution, steady-state verification, and startup/shutdown strategies; guide piloting through commercial implementation and embed learnings across the network.
• Collaboration And Matrix Leadership: Co-create with CMC, Clinical, Regulatory, QA, and site leaders to align on risk, control, and lifecycle strategies; harmonize processes across internal sites, CMOs, and acquisitions; maintain governance and accountability; communicate risk and portfolio alignment.
• Technology And Site Enablement: Ensure site readiness; stand up technology transfers to sites, define ways of working, and embed digital tools for monitoring and decision-making; coordinate technology readiness with site leads for new sites.
• Regulatory Partnership: Co-author design control strategies for post-approval flexibility; prepare teams and sites for regulatory interactions and inspections.
• Data-driven Improvement: Standardize process data and information for autonomous decision making; define metrics and scorecards; use feedback loops to track adoption and impact.
• What Success Looks Like: Standardisation and speed in platform delivery; continuous adoption of manufacturing innovations; network alignment across sites and CMOs; measurable operational impact in yields, variability, and supply timelines.

Qualifications

• Required: 12 years in biologics manufacturing (or 10+ with an advanced degree); 5+ years in process engineering/development; late-stage and commercial exposure; hands-on experience leading continuous bioprocessing initiatives; proven regulatory writing or strategy leadership; strong track record of leading matrix teams and influencing internal and external partners/CMOs.
• Preferred: Site engineering background; validation experience for new modalities/formulations; experience with late-phase nucleic acid manufacturing or analytics; proficiency with Power BI, Power Automate, and Microsoft Office.