Associate Director, Manufacturing Systems & Automation (CGT)

Responsibilities

• Lead the design, implementation, and lifecycle management of GMP manufacturing systems and automation platforms for cell and gene therapy (CGT) operations.
• Develop and execute digital manufacturing strategies, including real-time execution, electronic workflow orchestration, and automated data collection.
• Drive the deployment and optimization of SCADA, MES, LIMS, OSI Pi, eBR, and digital traceability systems.
• Partner with enterprise IT and Quality Assurance to define exception management strategies and electronic approval requirements.
• Lead cross-functional initiatives to improve manufacturing efficiency, system reliability, and data integrity.
• Ensure all manufacturing systems and electronic release processes comply with FDA GMP regulations, 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Develop SOPs, governance standards, and lifecycle management procedures for automation platforms.

Requirements

• Bachelor’s or Master’s degree in Engineering, Biotechnology, Automation, Computer Science, or a related discipline.
• 7-10 years of progressive experience in GMP manufacturing or automation leadership.
• At least 5 years of commercial digital/automation leadership specifically in CGT, Biologics, or Sterile filling operations.
• Proficiency with manufacturing systems including eBR, DCS/SCADA, Pi, ERP, and QMS.
• Strong knowledge of regulatory requirements, including investigations, CAPA, change control, and risk mitigation.
• Proven experience integrating first-of-kind equipment with manufacturing systems and managing digital transformations.

Preferred Qualifications

• Experience with automated batch review by exception and release by exception processes.
• Expertise in chain-of-custody and chain-of-identity for autologous and allogeneic CGT products.
• Strong ability to translate high-level digital maturity concepts into actionable insights for site leadership.

Benefits

• Medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the Summer and Winter.
• Educational assistance programs, including student loan repayment.
• 401(k) with company matching.
• Annual bonus and annual equity awards.

About the Company

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company is dedicated to advancing clinical and research programs for life-shortening genetic diseases and other serious conditions through deep insight into causal human biology.