Associate Director - Digital Manufacturing & Automation Lead, Cell Therapy
About The Position
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. The 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. Its focus includes MES, LIMS, manufacturing automation, robotics integration, Tulip applications, and process orchestration platforms that support end-to-end digital manufacturing workflows. The position combines technical product ownership with manufacturing systems expertise and hands-on OT/IT integration experience in regulated GMP environments. The role owns digital manufacturing platform delivery and product roadmaps, leads MES and LIMS workflow orchestration, and oversees Tulip applications and integrations with robotics, automation equipment, OT systems, edge devices, SAP, and analytics platforms. It also guides technical delivery, vendor work, Agile development, and compliance while supporting AI/ML, digital twins, manufacturing analytics, and intelligent automation. The Associate Director partners with cross-functional teams and supports site deployments, validation, training, and operational readiness.
Requirements
- Bachelor's degree in Computer Science, Engineering, Automation Engineering, Information Systems, Electrical Engineering, or a 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 the Tulip platform or similar low-code manufacturing platforms.
- Experience integrating manufacturing automation systems, robotics, environmental monitoring, and OT systems.
- Technical integration expertise in API development and integration.
- Experience with middleware platforms such as HighByte, OPC-UA, and MQTT.
- Experience with SMB or NFS file system management and scripting.
- Experience with database design and connectivity.
- Experience with 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.
Nice To Haves
- 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.
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 deliver digital batch execution, electronic work instructions, device integration, and real-time visibility.
- Serve as technical product owner to ensure solutions meet manufacturing and compliance requirements.
- Lead MES and LIMS workflow orchestration for 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 by reviewing technical designs and validating implementation quality.
- Own the Tulip application roadmap and delivery for shop floor execution, operator workflows, deviations, equipment monitoring, and process visibility.
- Define application requirements, user stories, and acceptance criteria; build or oversee reusable components, connectors, integrations, and low-code automation workflows.
- Partner with manufacturing subject matter experts to 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, scripting, and file system management.
- Lead MES and LIMS integration with SAP, automation systems, and analytics platforms.
- Enable real-time sample tracking, chain of identity and custody, and manufacturing genealogy.
- Define canonical data models for advanced analytics and AI use cases.
- Drive API integrations with SAP ERP, vein-to-vein systems, and custom or bespoke supplier applications.
- Manage delivery roadmaps, sprint planning, and stakeholder expectations as technical product owner.
- 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 to translate business requirements into scalable technical solutions and delivery plans.
- Support site deployments, validation, training, and operational readiness.
Benefits
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
- Qualified retirement programs.
- Paid time off, including vacation, holiday, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Director
