Associate Director - Digital Manufacturing & Automation Lead, Cell Therapy

AstraZeneca plc

California (MD)

On-site

USD 124,000 - 186,000

Full time

46 hours ago
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Benefits offered by this job

Short-term incentive bonuses
Equity-based awards
Health, dental, and vision coverage
Retirement programs

Job summary

AstraZeneca plc is seeking an Associate Director for Digital Manufacturing & Automation to lead design, implementation, and continuous improvement of next‑gen manufacturing platforms across Cell Therapy operations.

You will own MES/LIMS deployments, robotics integration, and process orchestration, partnering with OT/IT, Quality, and Product teams to enable compliant, scalable digital manufacturing across global sites.

Qualifications

  • Bachelor's degree in Computer Science, Engineering, Automation Engineering, Information Systems, Electrical Engineering, or related field
  • 8+ years in manufacturing systems, digital manufacturing, MES implementation, or automation engineering
  • Strong technical product ownership or program management experience leading complex manufacturing system implementations
  • Experience with MES/LIMS platforms in pharmaceutical, biotech, cell therapy, or regulated manufacturing
  • Hands-on experience with Tulip platform or similar low-code manufacturing platforms
  • Experience integrating manufacturing automation systems, robotics, environmental monitoring, and OT systems
  • Technical integration expertise: API development and integration; Middleware platforms (HighByte, OPC-UA, MQTT); File system management (SMB, NFS) and scripting; Database design and connectivity; Event-driven architectures
  • Experience with SAP manufacturing integrations
  • Ability to review and validate technical work by development teams and vendors
  • Strong understanding of GxP, CFR Part 11, data integrity, and validation requirements
  • Experience in Agile product delivery environments

Responsibilities

  • Own delivery of scalable digital manufacturing platforms across Cell Therapy operations
  • Lead development of MES, LIMS, automation interfaces, robotics workflows, and orchestration capabilities through internal teams and external partners
  • Define product roadmaps, manage technical backlogs, and drive delivery of digital batch execution, electronic work instructions, device integration, and real-time visibility
  • Serve as technical product owner ensuring solutions meet manufacturing and compliance requirements
  • Lead MES and LIMS workflow orchestration supporting autologous and allogeneic manufacturing processes
  • Design orchestration frameworks integrating MES, LIMS, ERP, automation systems, robotics, and data platforms
  • Define manufacturing process flows, APIs, data exchange patterns, and event-driven architectures
  • Manage vendor delivery, reviewing technical designs and validating implementation quality
  • Own Tulip application roadmap and delivery, partnering with development teams to build applications
  • Define application requirements, user stories, and acceptance criteria
  • Build or oversee development of reusable components, connectors, integrations, and low-code automation workflows
  • Partner with manufacturing SMEs to rapidly prototype and deploy solutions
  • Lead integration of robotics platforms, automation equipment, OT systems, and edge devices into enterprise platforms
  • Own technical delivery of automated material movement, manufacturing execution, environmental monitoring, and equipment telemetry
  • Perform hands-on integration including middleware configuration (HighByte, OPC-UA), scripting, and file system management
  • Lead integration of MES and LIMS with SAP, automation systems, and analytics platforms
  • Enable real-time sample tracking, chain of identity/custody, and manufacturing genealogy
  • Define canonical data models supporting advanced analytics and AI use cases
  • Drive API integrations with SAP ERP, vein-to-vein systems, and custom/bespoke supplier applications
  • Act as technical product owner managing delivery roadmaps, sprint planning, and stakeholder expectations
  • Apply Agile methodologies, CI/CD, DevSecOps, automated testing, and version control
  • Ensure applications are scalable, secure, maintainable, and GxP compliant
  • Review and validate technical work by development partners and vendors
  • Leverage AI/ML to optimize workflows, exception handling, predictive maintenance, and manufacturing intelligence
  • Support digital twins, manufacturing analytics, and intelligent automation implementation
  • Drive innovation through rapid experimentation and Industry 4.0 technology adoption
  • Partner with Manufacturing Operations, MSAT, Quality, Supply Chain, Automation Engineering, Digital IT, and vendors
  • Translate business requirements into scalable technical solutions and delivery plans
  • Support site deployments, validation, training, and operational readiness

Education

Bachelor's degree in Computer Science, Engineering, Automation Engineering, Information Systems, Electrical Engineering, or related field
8+ years in manufacturing systems, digital manufacturing, MES implementation, or automation engineering

Tools

Tulip platform
APIs
HighByte
OPC-UA
MQTT
SAP manufacturing integrations

Job description

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 operations
  • Lead development of MES, LIMS, automation interfaces, robotics workflows, and orchestration capabilities through internal teams and external partners
  • Define product roadmaps, manage technical backlogs, and drive delivery of digital batch execution, electronic work instructions, device integration, and real-time visibility
  • Serve 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 processes
  • Design orchestration frameworks integrating MES, LIMS, ERP, automation systems, robotics, and data platforms
  • Define manufacturing process flows, APIs, data exchange patterns, and event-driven architectures
  • Manage 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 visibility
  • Define application requirements, user stories, and acceptance criteria
  • Build or oversee development of reusable components, connectors, integrations, and low-code automation workflows
  • Partner 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 platforms
  • Own technical delivery of automated material movement, manufacturing execution, environmental monitoring, and equipment telemetry
  • Perform 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 platforms
  • Enable real-time sample tracking, chain of identity/custody, and manufacturing genealogy
  • Define canonical data models supporting advanced analytics and AI use cases
  • Drive 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 expectations
  • Apply Agile methodologies, CI/CD, DevSecOps, automated testing, and version control
  • Ensure applications are scalable, secure, maintainable, and GxP compliant
  • Review 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 intelligence
  • Support digital twins, manufacturing analytics, and intelligent automation implementation
  • Drive 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 vendors
  • Translate business requirements into scalable technical solutions and delivery plans
  • Support site deployments, validation, training, and operational readiness
Required Qualifications
  • Bachelor's degree in Computer Science, Engineering, Automation Engineering, Information Systems, Electrical Engineering, or related field
  • 8+ years in manufacturing systems, digital manufacturing, MES implementation, or automation engineering
  • Strong technical product ownership or program management experience leading complex manufacturing system implementations
  • Experience with MES/LIMS platforms in pharmaceutical, biotech, cell therapy, or regulated manufacturing
  • Hands-on experience with Tulip platform or similar low-code manufacturing platforms
  • Experience integrating manufacturing automation systems, robotics, environmental monitoring, and OT systems
  • Technical integration expertise:
    • API development and integration
    • Middleware platforms (HighByte, OPC-UA, MQTT)
    • File system management (SMB, NFS) and scripting
    • Database design and connectivity
    • Event-driven architectures
  • Experience with SAP manufacturing integrations
  • Ability to review and validate technical work by development teams and vendors
  • Strong understanding of GxP, CFR Part 11, data integrity, and validation requirements
  • Experience in Agile product delivery environments
Preferred Qualifications
  • Experience in Cell Therapy, Gene Therapy, biologics, or ATMPs
  • Experience with manufacturing orchestration platforms and digital thread architectures
  • Experience with HighByte, OPC-UA, MQTT, or industrial connectivity platforms
  • Experience integrating robotics platforms and autonomous manufacturing systems
  • Exposure to AI/ML applications in manufacturing operations
  • Experience designing manufacturing data platforms and operational analytics solutions
  • Knowledge of ISA-95, ISA-88, and Industry 4.0 principles
  • Programming experience with Python, JavaScript, Java, C#, or similar
  • Experience 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.

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