Associate Director, External Operations, Cell Therapy – External Supply Management

Associate Director, External Operations, Cell Therapy – External Supply Management

The Associate Director, External Operations, Cell Therapy – External Supply Management, leads external manufacturing partner operations. These operations span a network of CDMOs and external partners supporting cell therapy across autologous, allogeneic, in vivo, and new platforms. You will create operational governance, tech transfer, batch execution, investigations, and risk management to meet supply, quality, and cost targets. You will support programs across development, clinical, scale-up, validations, launch readiness and commercialization as portfolio evolves.

You will partner cross-functionally with CMC Product Leadership, Process Development, Quality, Regulatory, Procurement, and Finance to ensure external supply.

The role is based in Gaithersburg, MD and report to the Head of External Supply - Cell Therapy Products

You will:

• Lead daily operational management of assigned CDMOs/external manufacturing partners to ensure performance against supply, quality, and cost targets.
• Guide execution across tech transfer, manufacturing, release, delivery, issue resolution, deviations, investigations.
• Be a primary operational interface across technical operations, Quality, Supply Chain, Regulatory, CMC, Program management, finance, procurement and legal
• Lead change management implementation at external partners following CMC Product Strategy. Oversee/coordinate change control, impact assessment, and implementation plan.
• Establish and run partner governance, including business reviews, escalation pathways, performance monitoring and action tracking
• Translate program needs and demand plans into executable external supply plans and clear partner priorities
• Build, accountable relationships with external partners while on execution, quality, timeline, cost and supply reliability
• Support negotiations and content of contracts such as MSAs, SOWs, Change Orders and other commercial agreements to ensure they reflect operational scope, supply requirements, governance, milestones and cost of goods optimization. Manage supplier's performance against the contract deliverables.
• Oversee budget input to Program Budgets and monitor spend against budgets.
• Promote continuous improvements of external operations processes, scorecards and way of working across the network
• Ensure end-to-end integration of physical and financial flows in SAP across CDMO operations covering master data, subcontracting, batch status/release, GR/IR, variance and WIP settlement, and KPI reporting.

You have:

• Bachelor's degree in engineering, life sciences or related discipline is required; advanced degree preferred.
• Minimum 8+ years' experience in biotech, pharma or advanced therapy GMP operations.
• Experience applying lean, structural and continuous improvement to deliver more efficient and reliable operations.
• Cross-functional leadership, communication, and stakeholder management.
• Experience working in and with multiple geographies and achieve success through collaboration.
• Experience applying digital, analytics and AI-enabled workflows to improve visibility, workflow efficiency and operational execution.

Desired skills:

• Experience in SAP and inventory to COGS.
• At least 2 years of experience in cell and gene therapy including management of CDMOs and external suppliers.

The annual base pay for this position ranges from $115K to $173K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.