Operational Readiness Associate Director,

Job Description

Welcome to the Future of Precision Oncology – Join Us in Wilmington, DE!

We’re thrilled to announce the launch of our cutting-edge Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, Delaware—a bold step forward in transforming cancer care through innovation, collaboration, and purpose-driven science. This is more than a job - it’s a chance to be part of the next wave of cancer care. Whether you're an engineer, scientist, operator, or quality expert, your work here will contribute to life-changing therapies for patients around the world. Together, we’ll build a facility that not only meets the highest standards of safety and innovation but also fosters a culture of excellence, inclusion, and impact.

Join us in Wilmington and help shape the future of cancer treatment—one molecule at a time.

We invite you to become a part of our journey as the Operational Readiness Associate Director. This role offers you the chance to contribute to the site's development and ensure successful GMP manufacturing.

The Associate Director - Operational Readiness is accountable for end-to-end operational readiness planning and execution for a new site/facility introduction. The role integrates cross-functional workstreams into a single executable readiness plan, drives schedule acceleration opportunities, ensures governance discipline, and enables “operational excellence from day one”. The role operates in parallel with construction/commissioning activities to ensure the site is ready to accept handovers and achieve successful PPQ / facility approval readiness through robust SOPs, training, tech transfer alignment, incoming materials readiness, procurement execution, and risk controls.

Responsibilities

• Build, maintain, and govern the integrated operational readiness schedule across workstreams (SOPs, Tech Transfer, Incoming Materials, Procurement) aligned to the Integrated Master Schedule and critical path.
• Drive schedule convergence and acceleration: identify dependencies, sequencing conflicts, resourcing gaps, and pull-forward actions; run weekly lookahead planning and escalation for overdue/at-risk deliverables.
• Establish readiness stage-gates and define entry/exit criteria with stakeholders to confirm readiness at critical milestones.
• Coordinate prioritization, drafting, field shakedown, review, and approval of SOPs to enable shopfloor readiness.
• Ensure clear document strategy and ownership (e.g., what lives in SOP vs eBR vs local instructions) and maintain a document tracker integrated into the master schedule.
• Coordinate effectively across teams to guarantee proper resolution and communication of outstanding safety and risk-related tasks.
• Ensure operational readiness deliverables and timing remain aligned to Tech Transfer plans and QC method transfer planning.
• Integrate key Tech Transfer and QC readiness milestones into site reporting and governance.
• Oversee change control processes to ensure they are fully aligned with regulatory requirements, optimized for efficiency, and consistently executed according to established schedules.
• Drive operational excellence foundations: tier governance cadence, GEMBA/self-inspection routines, and readiness operating model embedded from the start.
• Enable stable execution through standard work, performance management, and continuous improvement rituals.
• Coordinate supplier transparency, material master data readiness, BOM redlines, and incoming materials strategy/list development.
• Ensure materials readiness is linked to eBR/MES needs, procurement lead times, and commissioning/start-up sequencing.
• Own the operational readiness risks & issues management: identification, assessment, mitigation planning, and escalation.
• Maintain and govern the operational readiness risk register; ensure mitigations have owners, due dates, and are integrated into the readiness schedule.
• Facilitate recurring risk reviews and ensure lessons learned feedback into schedule, training, and readiness deliverables.
• Build and maintain readiness dashboards (tier boards/scorecards) and schedule conformance; drive consistent weekly reporting.
• Define and implement KPI reporting discipline for monthly leadership updates; ensure data integrity and clear action linkage.
• Track readiness KPIs such as Right-First-Time execution, conformance to schedule, and critical path adherence; drive countermeasures through tier governance.
• Ensure operations is embedded with the project team and prepared for handover through early training exposure and readiness deliverables tied to system lifecycle activities.
• Promote a strong ownership and learning culture; leverage best practices and lessons learned from sister sites or prior l