Associate Director - Digital Manufacturing & Automation Lead, Cell Therapy
AstraZeneca · California, MD · 2 days ago
Management$124k–$186k/yrFull-time
The Associate Director, Digital Manufacturing & Automation will lead the design, implementation, integration, and continuous improvement of next-generation manufacturing digital platforms supporting Cell Therapy operations. This role bridges Manufacturing Operations, Automation Engineering, Digital IT, Quality, and Product teams to enable scalable, compliant, and intelligent manufacturing ecosystems across global Cell Therapy sites. The primary focus is architecting and delivering advanced manufacturing capabilities including MES, LIMS, manufacturing automation, robotics integration, Tulip applications, and process orchestration platforms supporting end-to-end digital manufacturing workflows. The ideal candidate possesses strong technical product ownership capabilities combined with deep manufacturing systems expertise and hands-on experience integrating OT/IT ecosystems in regulated GMP environments. Key Responsibilities Digital Manufacturing Platforms Own delivery of scalable digital manufacturing platforms across Cell Therapy operationsLead development of MES, LIMS, automation interfaces, robotics workflows, and orchestration capabilities through internal teams and external partnersDefine product roadmaps, manage technical backlogs, and drive delivery of digital batch execution, electronic work instructions, device integration, and real-time visibilityServe as technical product owner ensuring solutions meet manufacturing and compliance requirements MES & LIMS Workflow Orchestration Lead MES and LIMS workflow orchestration supporting autologous and allogeneic manufacturing processesDesign orchestration frameworks integrating MES, LIMS, ERP, automation systems, robotics, and data platformsDefine manufacturing process flows, APIs, data exchange patterns, and event-driven architecturesManage vendor delivery, reviewing technical designs and validating implementation quality Tulip Manufacturing Applications Own Tulip application roadmap and delivery, partnering with development teams to build applications supporting shop floor execution, operator workflows, deviations, equipment monitoring, and process visibilityDefine application requirements, user stories, and acceptance criteriaBuild or oversee development of reusable components, connectors, integrations, and low-code automation workflowsPartner with manufacturing SMEs to rapidly prototype and deploy solutions Robotics & Manufacturing Automation Integration Lead integration of robotics platforms, automation equipment, OT systems, and edge devices into enterprise platformsOwn technical delivery of automated material movement, manufacturing execution, environmental monitoring, and equipment telemetryPerform hands-on integration including middleware configuration (HighByte, OPC-UA), scripting, and file system management Enterprise Systems Integration Lead integration of MES and LIMS with SAP, automation systems, and analytics platformsEnable real-time sample tracking, chain of identity/custody, and manufacturing genealogyDefine canonical data models supporting advanced analytics and AI use casesDrive API integrations with SAP ERP, vein-to-vein systems, and custom/bespoke supplier applications Technical Leadership & Solution Delivery Act as technical product owner managing delivery roadmaps, sprint planning, and stakeholder expectationsApply Agile methodologies, CI/CD, DevSecOps, automated testing, and version controlEnsure applications are scalable, secure, maintainable, and GxP compliantReview and validate technical work by development partners and vendors AI & Advanced Digital Manufacturing Leverage AI/ML to optimize workflows, exception handling, predictive maintenance, and manufacturing intelligenceSupport digital twins, manufacturing analytics, and intelligent automation implementationDrive innovation through rapid experimentation and Industry 4.0 technology adoption Cross-Functional Collaboration Partner with Manufacturing Operations, MSAT, Quality, Supply Chain, Automation Engineering, Digital IT, and vendorsTranslate business requirements into scalable technical solutions and delivery plansSupport site deployments, validation, training, and operational readiness Required Qualifications Bachelor's degree in Computer Science, Engineering, Automation Engineering, Information Systems, Electrical Engineering, or related field8+ years in manufacturing systems, digital manufacturing, MES implementation, or automation engineeringStrong technical product ownership or program management experience leading complex manufacturing system implementationsExperience with MES/LIMS platforms in pharmaceutical, biotech, cell therapy, or regulated manufacturingHands-on experience with Tulip platform or similar low-code manufacturing platformsExperience integrating manufacturing automation systems, robotics, environmental monitoring, and OT systemsTechnical integration expertise:API development and integrationMiddleware platforms (HighByte, OPC-UA, MQTT)File system management (SMB, NFS) and scriptingDatabase design and connectivityEvent-driven architecturesExperience with SAP manufacturing integrationsAbility to review and validate technical work by development teams and vendorsStrong understanding of GxP, CFR Part 11, data integrity, and validation requirementsExperience in Agile product delivery environments Preferred Qualifications Experience in Cell Therapy, Gene Therapy, biologics, or ATMPsExperience with manufacturing orchestration platforms and digital thread architecturesExperience with HighByte, OPC-UA, MQTT, or industrial connectivity platformsExperience integrating robotics platforms and autonomous manufacturing systemsExposure to AI/ML applications in manufacturing operationsExperience designing manufacturing data platforms and operational analytics solutionsKnowledge of ISA-95, ISA-88, and Industry 4.0 principlesProgramming experience with Python, JavaScript, Java, C#, or similarExperience with cloud-native applications and CI/CD pipelines #CellTherapy The annual base pay for this position ranges from $124K to $186K. Our positions offer eligibility for various 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. Date Posted 23-Oct-2026 Closing Date 05-Nov-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.