Director, Material Operations - Cell & Gene Therapy

Job Description

General Summary:

The Director, Cell and Gene Therapy Material Operations (CGT MatOps) is responsible for building and leading the Material Operations team within the broader Material Operations and Technical Operations (MOTO) Department. Vertex is rapidly progressing a pipeline of exciting cell and genetic therapy programs requiring development of sustainable and scalable Material Operations capabilities across multiple sites in the Boston area. The Director, CGT MatOps is accountable for the fully integrated material supply for site based internal manufacturing operations including, not limited to, site readiness, material planning, supplier management and procurement, receipt, storage transportation, and production order fulfillment of GMP raw materials and consumables in support of activities on the Manufacturing floor. The MatOps team is responsible for collaborating with key CGT Leadership to compile, secure funding, track and deliver capital investments for, and subsequent operational readiness of, innovative technologies and expanded capacity to meet the development and commercialization of multiple program timelines. The Director has impact and interaction across multiple Vertex departments and will represent the broader MOTO team in several senior level forums. The Director is responsible for delivering reliable material supply for clinical programs and successful commercial launches for Type 1 Diabetes (T1D) and other products from the portfolio.

This role will report to the Executive Director, CGT MOTO or designee and is an On-Site position. The position is based at Vertex's Leiden Center 1 in Boston, MA.

Key Responsibilities:

• Define a comprehensive clinical and initial commercial supply chain strategy for a set of diverse pipeline programs in alignment with Vertex's corporate strategy. This strategy includes defining the key elements of collaboration with the Commercial Supply Chain team to ensure a seamless transition of Commercial Supply Chain responsibility at the appropriate time. It also includes a 1-3+ year forward looking assessment of T1D demand forecast scenarios across T1D clinical and initial commercial.
• Leadership of Site Based Material Planning process to enable capacity investments and expansion across Vertex owned and operated and CDMO network. Partner with Finance and Commercial colleagues to deliver a capacity plan including balancing a complex assessment of cost/COGS implications and risks. Drive Systems Implementation including Oracle Material Management Modules for Inventory control and Direct Procurement, RTMS for production capacity modeling and scheduling and Rapid Response for Planning and Procurement.
• Responsible for proactively assessing risk across material operations and building mitigation plans. This includes delivering a risk-based materials sourcing strategy and safety stock and storage location plan for multiple bill of materials and critical components used in the Cell therapy manufacturing process.
• In collaboration with CMSC, deliver an integrated material operations launch plan for the T1D programs and other future pipeline programs. This strategy includes establishing safety stock for raw materials, operational readiness of end-to-end material operations to successfully launch, capacity analysis, integration of systems to reduce manual processes and improve compliance and efficiency. 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.
• Responsible for creating a comprehensive, compliant scheduling and manufacturing slot allocation program for multiple therapies to ensure efficient utilization of global manufacturing capacity and a seamless patient experience. This program will consider several factors including a balance of clinical and commercial demand globally.
• Drive excellence in end-to-end operations through identification and management of key material operation 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 supply chain and/or manufacturing leadership roles in the Biopharmaceutical industry. Experience with Cell Therapy, Genetic Therapy and Biological products and technologies is preferred.
• Advanced degree in Supply Chain Management or related field and Certifications in Planning, Procurement, Material Management or other relevant field is preferred.
• Minimum 5 years experience with Cell and Gene Therapy material management in commercial manufacturing setting.
• Expert level proficiency with ERP systems including module implementation and system integrations.
• Experience in building and managing a complex global material supply chain network.
• The candidate is expected to be a thought leader in supply chain 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 supply chain 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 fifty 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.
• 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 evolves.

#LI-onsite #LI-SV1

Flex Designation:

Flex Eligibility Status:

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