Associate Director, Manufacturing Systems & Automation (CGT)

Location: Boston, MA; five days per week on-site at LC1, Boston

Salary: $160,000–$240,000 per year, plus eligibility for an annual bonus and annual equity awards.

Company

Vertex is a global biotechnology company investing in scientific innovation and developing therapies for patients.

What you will do

• Lead the design, implementation, integration, validation, and lifecycle management of GMP manufacturing systems and automation platforms for cell and gene therapy operations.
• Develop digital manufacturing strategies for real-time execution, electronic workflows, automated data collection, equipment integration, process monitoring, analytics, and reporting.
• Drive deployment and optimization of SCADA, MES, LIMS, OSI Pi, electronic batch records, batch review by exception, release by exception, and paperless execution.
• Lead digital traceability initiatives for chain of custody and chain of identity across patient-specific autologous and allogeneic products.
• Partner with enterprise IT and Quality Assurance on exception management, review workflows, electronic approvals, and accelerated batch disposition.
• Establish SOPs, governance standards, KPIs, and lifecycle procedures while maintaining inspection readiness and continuous improvement.

Requirements

• Bachelor’s or master’s degree in engineering, biotechnology, automation, computer science, life sciences, or a related discipline.
• 7–10 years of progressive GMP manufacturing or automation leadership experience, including at least 5 years of commercial digital or automation leadership in CGT, biologics, or sterile filling operations.
• Experience commercializing first-of-kind equipment integrations, automated batch review and release by exception, and chain-of-custody and chain-of-identity systems.
• Proficiency with manufacturing systems such as eBR, DCS/SCADA, OSI Pi, ERP, and QMS.
• Strong knowledge of FDA GMP, 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+ data integrity, investigations, CAPA, change control, and risk mitigation.
• Must be able to work on-site five days per week in Boston, Massachusetts.

Culture & Benefits

• Leadership opportunity within the CGT Manufacturing and Process Engineering organization.
• Medical, dental, and vision benefits with paid time off and company shutdowns in summer and winter.
• Educational assistance, including student loan repayment programs.
• Commuting subsidy, matching charitable donations, and 401(k) benefits.
• Continuous learning encouraged in AI, technology, automation, and industry trends.