Operational Readiness Associate Director,

Job Description

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

Were thrilled to announce the launch of our cutting-edge Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington Delawarea bold step forward in transforming cancer care through innovation collaboration and purpose-driven science. This is more than a job - its a chance to be part of the next wave of cancer care. Whether youre an engineer scientist operator or quality expert your work here will contribute to life-changing therapies for patients around the world. Together well 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 treatmentone 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 sites 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 launches where applicable.

Qualifications

Required

• Bachelors of Science (BS) Degree in engineering science or related discipline.
• Eight or more (8) Years of experience in project portfolio or program management.

Preferred

• Program/Project credential (PMP PgMP or equivalent)
• Demonstrated program/portfolio management experience (integrated schedules dependencies critical path governance cadence).
• Experience leading cross-functional readiness launch or operationalization programs in regulated manufacturing environments.
• Strong risk/issue management discipline (risk registers mitigation ownership escalation).
• Executive-ready communication skills: concise dashboards narrative updates and decision framing.
• New facility introduction / expansion experience; operational readiness executed in parallel with construction/commissioning.
• Familiarity with tier-based management systems and shop floor cadence.
• Lean / Six Sigma experience
• Exposure to digital manufacturing foundations (e.g. MES/eBR readiness coordination).
• Proven experience leading large cross-functional projects from initiation to successful delivery
• Ability to thrive in dynamic environments and adapt quickly to shifting priorities
• Skilled in influencing decisions on complex technical challenges
• Strong organizational and self-management skills; able to prioritize and adjust workload effectively
• Effective collaboration across diverse functions (e.g. Technical Services Engineering Quality QC IT Operations) with ability to integrate workstreams
• Demonstrated ability to influence peers and business partners
• Strong interpersonal and team-building skills; foster effective collaboration among diverse styles
• Track record of delivering high-performance projects on time and within budget
• Proficient in continuous improvement methodologies (Lean Six Sigma etc.)
• Familiarity with documentation deviation and change management systems (e.g. Veeva QualityDocs Kneat)

Required Skills:

Preferred Skills:

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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