Associate Director, Manufacturing Systems & Automation (CGT)
Vertex Pharmaceuticals · Boston, MA
CMCFull-time$160k–$240kCompany career page
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Role summary
Vertex Pharmaceuticals seeks an Associate Director to lead manufacturing systems and automation strategy for cell and gene therapy operations in Boston. The role involves designing GMP systems, driving digital manufacturing initiatives, and ensuring regulatory compliance across multiple sites.
What they're looking for
- Bachelor's or master's degree in engineering, biotechnology, automation, computer science, or life sciences
- 7-10 years progressive GMP manufacturing or automation leadership experience
- 5+ years commercial digital/automation leadership in CGT, biologics, or sterile filling
- Experience integrating first-of-kind equipment and implementing batch review by exception systems
- Proficiency with eBR, SCADA, MES, LIMS, and ERP systems
- Strong knowledge of FDA GMP regulations, 21 CFR Part 11, EU Annex 11, and GAMP 5
What you'll be doing
- Lead design, implementation, and lifecycle management of GMP manufacturing systems and automation platforms
- Develop and execute digital manufacturing strategies enabling real-time execution, data collection, and process monitoring
- Drive deployment of SCADA, MES, LIMS, electronic batch records, and exception-based review initiatives
- Lead cross-functional initiatives to improve manufacturing efficiency, system reliability, and data integrity
- Ensure manufacturing systems maintain regulatory compliance and inspection readiness with global standards
Privacy & handoff
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