Vertex · 15 hours ago
Director, Engineering Operations (Cell and Genetic Therapies)
Boston, MA
Full-time
Onsite
Director/Executive
$187K/yr - $281K/yr
10+ years expVertex is a global biotechnology company that invests in scientific innovation. The Director, Engineering Operations – CGT is responsible for building and leading the Engineering Operations team within the Biopharmaceutical Sciences – Cell & Gene Therapy Manufacturing and Process Engineering organization, ensuring the development of sustainable and scalable clinical and commercial manufacturing capabilities.
Computer Software
Responsibilities
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 that all activities and documentation comply with global regulatory requirements. Understand and implement processes and controls that align with evolving Health Authority regulatory expectations
Qualification
Required
10-15 years progressive experience in GMP Manufacturing/Process Engineering leadership roles in the Biopharmaceutical industry
Bachelor Degree in an Engineering discipline
Minimum 10 years' experience with GMP biopharmaceutical manufacturing environment including experience in commercial setting
Expert level proficiency with Manufacturing Related Process Engineering and Project Engineering with Advance level of proficiency with Manufacturing systems including eBR, DCS/SCADA, Pi, ERP, QMS with system integrations and paperless execution strategies
Expert level proficiency with Investigations, Root Cause Analysis, CAPA, Change Control, Risk Assessment/Mitigation
Advanced level proficiency in Aseptic Operations including Process Simulation, Personnel Qualification, Facility Cleaning and GMP Training and associated Regulatory Requirements for Commercial Drug Product Manufacturing
Experience in building and managing a high performing team supporting complex biologics-based manufacturing operations
The candidate is expected to be a thought leader in engineering or related fields and have a proven ability to innovate and implement practical, compliant solutions
A proven ability to work seamlessly across teams and develop partnerships with peers is critical to success in this role
Understanding of the principles and regulations associated with manufacturing operations for biological, cellular, and genetic therapies
A results-oriented leader with a sense of urgency to deliver quality results in a highly ethical and professional manner
Motivational leadership of a cohesive high-performing team of greater than twenty members within a global, matrixed environment; the ability to articulate vision and successfully drive execution
Excellent communication and interpersonal skills with the ability to communicate complex issues and solutions enterprise-wide
An excellent team player who can build and sustain respect and trust at all levels of the organization
Ability to anticipate adverse scenarios and provide contingency plans to address them
Sound judgment and business acumen with personal versatility and flexibility as the business and team evolve
Preferred
Experience with Cell Therapy, Genetic Therapy and Biological products and technologies is preferred
Advanced degree preferred
Benefits
Medical, dental and vision benefits
Generous paid time off (including a week-long company shutdown in the Summer and the Winter)
Educational assistance programs including student loan repayment
A generous commuting subsidy
Matching charitable donations
401(k)
Company
Vertex
Vendor intelligence that combs through your supplier, manufacturer, logistics data to detect where you're leaving money on the table.
2-10 employees
H1B Sponsorship
Vertex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (18)
2023 (7)
2022 (13)
2021 (5)
2020 (7)
Funding
Current Stage
Early StageCompany data provided by crunchbase