Associate Director, Automation Projects Lead

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Summary:

The Associate Director, Automation Projects Lead - Cell Therapy (CT) Manufacturing Systems, will oversee a team of IT professionals, including direct reports, indirect reports, and contractors, to identify, develop, and deliver innovative and reliable digital solutions that address the future needs of the Devens Cell Therapy facility. This individual will collaborate closely with site operational functions to maximize the value of the automated CT platform, thereby enhancing patient access to Cell Therapy treatments.

Reporting to the Director of Business Insights & Technology (BI&T) for the Devens Cell Therapy Facility, this role will be responsible for setting the strategic direction of IT systems for the automated manufacturing platform, ensuring quality, and promoting the efficiency and sustainability of digital solutions implemented at the Devens CTF.

Responsibilities & Duties:

• Serve as the primary Digital Plant point of contact for the Devens Cell Therapy Facility's automated platform, including Automation Systems (Process and Lab IT automation), data collection (Aveva PI), and analytics deliverables.

• Collaborate with Devens CTF Operations colleagues (Manufacturing, MS&T, QC, Quality, Site Engineering), Enterprise teams (Global MS&T, Enterprise MES), the Enterprise Business team, and local system Digital Capability Managers to meet the following requirements:

  • Deliver the requirements for the Process Automation Systems (DeltaV) infrastructure and unit operations within the process automation system.

  • Address integration needs with the Manufacturing Execution System (Syncade), Scheduler and Data Historian (Aveva PI).

  • Develop and integrate the Lab IT data pipeline with MES, LIMS, ELN, and QC automation hardware.

• Identify and create strategies to operationalize breakthrough digital solutions, such as Artificial Intelligence, advanced image processing, and machine learning, to ensure the automated platform remains competitive in the future.

• Help set the priorities for PAS and Lab IT at Devens CTF and coordinate their deliveries.

• Lead technical teams to develop requirements, code, test deliverables, and drive system testing execution at the site level.

• Network and collaborate with other cell therapy PAS and Lab IT leads to proactively identify and resolve issues related to cell therapy requirements.

• Work with enterprise PAS and Lab IT teams and SMEs to develop standards, philosophies, design approaches, and SOPs for the Devens CTF automated platform.

• Collaborate with site teams and the business to develop a Business Continuity Plan for Devens CTF PAS and Lab IT applications related to the automated platform.

• Drive and support the resolution of critical PAS and Lab IT issues.

• Provide IT leadership for site inspection readiness from a PAS/Lab IT perspective.

• Coach and mentor PAS and Lab IT engineers on CTF automated platform requirements and deliverables.

Competencies: Knowledge, Skills & Abilities:

• Demonstrated expertise in Process Automation Systems, specifically DeltaV, and data collection (i.e. Aveva PI).

• Demonstrated expertise in MES platforms.

• Expert understanding of S88, S95 and batch processing operations required.

• Knowledge of Laboratory IT systems (e.g., LIMS) and automation scheduling software (e.g., Cellario, SmartQC) preferred.

• Understanding of engineering documentation such as P&IDs, process flow diagrams and standard operating procedures.

• Ability to troublesh