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 crossfunctionally 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 suppliers 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 endtoend 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:

• Bachelors 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.

• Crossfunctional 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.