Vertex

Biotechnology

AssociateDirector,ManufacturingSystems&Automation(CGT)

$160–240k Boston, Massachusetts, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“Associate Director, Manufacturing Systems & Automation (CGT) at Vertex. Skills: Manufacturing Systems, Automation, CGT Manufacturing, Digital Manufacturing. Lead design, implementation, integration, lifecycle management. Develop and execute digital manufacturing strategies”

What You'll Achieve.

Improve manufacturing efficiency; Improve system reliability; Improve data integrity; Reduce batch review timelines; Support accelerated batch disposition; Drive operational efficiency; Drive continuous improvement

Industry & Context.

Biotechnology
Problems you'll solve

Analytical problem-solving

What They're Looking For.

Must Have

Bachelor’s or master’s degree, 7-10 years progressive experience, 5 years commercial digital/automation leadership, Implementation and commercialization experience

Nice to Have

Master's degree

What You'll Do.

Develop and execute digital manufacturing strategies

Drive deployment and optimization of SCADA

Lead cross-functional initiatives

Partner with enterprise IT and Quality Assurance

Drive reduction in batch review timelines

Support accelerated batch disposition

Lead implementation and governance of digital traceability systems

Ensure manufacturing systems aligned with regulations

Ensure manufacturing systems maintain inspection readiness

lifecycle management procedures

Track and manage key metrics and KPIs

How You'll Work.

Team & Collaboration

Cross-functional initiatives; Enterprise IT; Quality Assurance

Communication Scope

Advise leadership team; Direct interaction with regulatory authorities

Full Job Description

**Job Description** **General Summary** We are seeking an experienced **Associate Director, Manufacturing Systems and Automation – CGT** to lead the manufacturing systems and automation team within the Biopharmaceutical Sciences – Cell & Gene Therapy (CGT) Manufacturing and Process Engineering organization. This role is critical in developing the current team to support scalable clinical and commercial manufacturing across multiple Boston-area sites. The Associate Director is responsible for leading the strategy, implementation, integration, validation, and continuous improvement of GMP manufacturing systems supporting cell and gene therapy operations. This role provides technical and operational leadership for digital manufacturing initiatives focused on manufacturing execution, automation integration, electronic batch records, and end-to-end product traceability. This position reports to the Director, CGT Engineering Operations and is designated as on-site, based at LC1, Boston. **Key Duties and Responsibilities:** * Lead the design, implementation, integration, and lifecycle management of GMP manufacturing systems and automation platforms supporting cell and gene therapy manufacturing operations * Develop and execute digital manufacturing strategies enabling real-time manufacturing execution, electronic workflow orchestration, automated data collection, equipment integration, process monitoring, manufacturing analytics and reporting * Drive deployment and optimization of SCADA, MES, LIMS, OSI Pi, eBR, batch review by exception , release by exception, chain of custody/chain of identity, digital and smart manufacturing initiatives * Lead cross-functional initiatives to improve manufacturing efficiency, system reliability, and data integrity * Partner with enterprise IT and Quality Assurance to define exception management strategies, review workflows, and electronic approval requirements * Drive reduction in batch review timelines and support accelerated batch dispo

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