Director, Operational Excellence- Cell Therapy Manufacturing

AstraZeneca•Gaithersburg, MD

About The Position

The Director, Operational Excellence (OE) leads the network-wide OE agenda for AstraZeneca's autologous Cell Therapy. This role involves establishing basic conditions and eliminating waste across the vein-to-vein value stream, operating in a matrix with site-based OE Leads. The Director sets strategy, governs the improvement portfolio, and delivers measurable outcomes in cost, productivity, service, quality, safety, and compliance. Additionally, the position is responsible for building sustainable capabilities for scale within the organization.

Requirements

Bachelor's in engineering/Life Sciences or related.
10+ years in GMP manufacturing.
5+ years leading programs.
Recognized Lean Six Sigma Black Belt or equivalent depth of OE expertise.
Experience with COGM/productivity improvements using lean, digital, and analytics.
Expertise in value stream management and lean (Hoshin, A3, VSM, standard work, tier/visual management, leader standard work); Genba execution.
Command of cGMP, data integrity, and GAMP; experience with MES/EBR/LIMS and other digital systems.
Track record in cross-site program leadership, portfolio governance, and benefits realization with Finance.
Demonstrated experience in Influence without authority, change leadership, and process/project/risk/Analytical skills.

Nice To Haves

Advanced degree preferred.

Responsibilities

Lead end-to-end value stream mapping.
Deploy Hoshin/strategy deployment to translate targets, such as COGM, capacity, and service, into a governed portfolio with clear owners, milestones, risks, and benefits.
Create standardized COGM/productivity dashboards and benefit tracking with Finance.
Lead programs (cycle time, labor models, MES/EBR enablement, yield, changeovers/scheduling, deviation reduction, automation/technology insertion).
Apply the AZ Lean Model (A3, VSM, standard work, daily/tier management, leader standard work, adapted SMED).
Facilitate development of business processes for training, batch execution, deviations, and patient/lot scheduling and logistics.
Lead Kaizen events; scale best practices across the Cell Therapy Development and Operations.
Define basic conditions for Cell Therapy Manufacturing Sites and build capability at all levels; coach leaders and value stream owners.
Partner with Supply Chain to vein-to-vein flow, slotting, and cold-chain logistics, safeguarding Chain of Identity/Chain of Custody.
Ensure improvements uphold safety, patient focus, and cGMP for ATMPs (including GAMP and data integrity).
Partner with Quality to reduce human error and increase First Pass Success and right-first-time performance.
Align senior leaders on priorities and resources; communicate impact through governance forums.