Director, Engineering Operations (Cell and Genetic Therapies)

Job Description

Director, Engineering Operations (Cell and Genetic Therapies)

General Summary:

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.

Key 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.

Minimal Requirements:

• 10-15 years progressive experience in GMP Manufacturing/Process Engineering leadership roles in the Biopharmaceutical industry. Experience with Cell Therapy, Genetic Therapy and Biological products and technologies is preferred.
• Bachelor Degree in an Engineering discipline with an advanced degree preferred.
• 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.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com