Director, Engineering Operations; Cell and Genetic Therapies

Job Description

Director, Engineering Operations (Cell and Genetic Therapies)

The Director, Engineering Operations - CGT is responsible for building and leading the Engineering Operations team within the broader Biopharmaceutical Sciences - Cell & Gene Therapy (CGT) Manufacturing and Process Engineering organization. Vertex is rapidly progressing a pipeline of exciting cell and genetic therapy and biologics programs requiring development of sustainable and scalable clinical and commercial manufacturing capabilities across multiple sites in the Boston area.

The Director is accountable for the full spectrum of engineering value-added services provided for site-based internal CGT manufacturing operations. Areas of responsibility include, but are not limited to, Process/Project Engineering, Manufacturing Technical Operations, Digital Systems and Validation, in direct support of CGT Internal Manufacturing Operations. The Engineering Operations team is also responsible for collaborating with key CGT Leadership to compile, secure funding, track and deliver capital investments for innovative technologies and expanded capacity to meet the development and commercialization program timelines.

The Director has impact and interaction across multiple Vertex departments and will represent the broader team in several senior level forums. The Director is responsible for delivering engineering support for clinical programs and commercial operations for Cell and Gene based modalities as assigned to support the product portfolio.

This role will report to the VP CGT Manufacturing and Process Engineering or designee and is an On-Site position. The position is based at Vertex's Leiden Center 1 in Boston, MA, however, will also have responsibilities for other locations in the Boston metro area.

• Define a sustainable and scalable strategy for engineering support of internal GMP manufacturing facilities in alignment with Vertex's corporate strategy
  . This strategy includes defining the key elements of collaboration with the Intermediate and Final Product manufacturing leaders, Regulatory, Quality Assurance, Finance, Corporate Facilities and Engineering, DTE and Commercial Supply Chain team to ensure seamless transitions to Commercial operations at the Boston facilities while continuing to provide clinical supply.
• Leadership of the Validation Team
  . This team is responsible for compliance with US and ROW regulatory requirements as they apply to cGMP CGT Manufacturing Facility and Equipment Qualifications including Site and Project related Validation Master Plans, Clean Room Environment PQ and Clean Utility PQ, and the Periodic Assessment and Requalification program as well as initial and periodic, Aseptic Process Simulation (APS).
• Leadership of the Process/Project Engineering Team. This includes assessing current state to identify and fill skill gaps by building a team that can actively support on-going CGT manufacturing operations with continuous improvement opportunities, troubleshooting in real-time issues that disrupt the manufacturing process and implementing alarm management and process controls related digital systems to ensure compliant operations. Drive execution of the Capital Plan and Operational Readiness within schedule constraints while maintaining budget.
• Leadership of the Manufacturing Technical Operations Team
  , maintain Center of Excellence approach to managing QMS related records and facilitate investigations, root cause analysis, CAPA development, change control, risk management, associated trackers, KPI's and Metrics to facilitate the CGT Culture of Compliance.
• Leadership of the Digital Systems Team. This team is responsible for Driving Initial Implementation and Lifecycle management of Digital Systems Road Map for Cell Manufacturing including Oracle Material Operations Modules for Inventory control and Direct Procurement, RTMS for production capacity modeling and scheduling, Rapid Response for Planning and Procurement, Distributed Control System, LIMs and MES.
• In collaboration with key stakeholders and leadership support the integrated operations launch plan for the CGT pipeline programs. This strategy includes establishing and maintaining an audit ready state of the Boston Manufacturing CGT Sites across full spectrum of areas of accountability to efficiently and effectively achieve approval to produce commercial CGT intermediate and final drug products. The Director is responsible for leading the team through launch readiness and hyper care, including making risk-based decisions to enable program success, while supporting the ongoing concurrent Clinical Manufacturing and Process Development activities.
• Drive excellence in end-to-end operations through identification and management of key metrics and KPI's. Drive operational efficiency, flawless execution, and continuous improvement across the supply chain to deliver a best-in-class supply chain.
• Champion the culture of quality and ensure…