Job Description

General Summary:

Reporting to the Director, Materials Operations, this role is responsible for developing and executing the Materials Management Technical Support strategy for Manufacturing support operations, material control process design, compliant material flows, and system reconciliation in support of product commercialization.  The individual will also support key Materials Management systems and processes, including change controls, risk assessments, deviations, and GMP documentation.

This role provides oversight of commercial material control process development, materials management system design, warehouse material flows and performance monitoring.  The Senior Manager will collaborate cross-functionally with Manufacturing, Process Development (PD), Quality Control (QC), Operational Quality, Facilities, Operations, and other stakeholders to enable compliant material flows and sustained manufacturing support.

Key Duties and Responsibilities:

• Own the development of SOPs, work instructions, and related documentation required for commercial Materials Management, and tech transfer of new products and programs
• Represent Materials Management at cross-functional daily management meetings, maintaining visibility to technical issues and action plans across warehouses and production staging areas
• Develop strategy and procedures for integrating Materials Management digital systems (ERP, MRP, WMS, Serialization, etc.) with compliant material flows.  Identify Key Performance Indicators (KPI) and reconciliation processes
• Serve as the primary escalation point for Material Management issues; coordinate resolution with subject matter experts and communicate status to management
• Support deviation management, CAPA, and change control activities, as needed. Serve as the process SME for Materials Management.  Support Materials Management investigations and root cause analyses
• Partner with Managed Service Provider program managers to monitor performance, optimize schedules, and update statements of work to support evolving business requirements
• Identify warehouse and material control innovations to drive efficiencies at scale
• Implement standard work, process confirmations, and support tiered management initiatives
• Design and maintain physical and system material flows, deploying Kanban systems and other methodologies to support 24x7 manufacturing
• Lead Technical Support initiatives, contribute to strategy development, and lead team resources to achieve Material Operations objectives.
• Oversee the sustained performance and continuous improvement of cell and gene therapy Materials Management processes.
• Ensure compliance with all regulatory, corporate, and Quality System requirements

Knowledge and Skills:

• Demonstrated experience in manufacturing support operations, warehouse management, and cGMP material control
• Proficient in ERP/MRP/WMS and related supply chain systems
• Strong technical problem-solving, technical writing, and presentation skills. Lean Six Sigma Green Belt or Black Belt preferred
• Strong sense of urgency, with the ability to escalate issues promptly and communicate transparently with stakeholders and management
• Ability to work independently with minimal supervision, manage multiple priorities, and support several projects simultaneously
• Strong interpersonal, collaboration, and teamwork skills

Education and Experience:

• BS or MS in Supply Chain or a related discipline
• 6 years of experience supporting site-based materials management in cell and gene therapy manufacturing, biopharmaceutical manufacturing, or a related pharmaceutical environment
• 3 years of leadership experience

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 [email protected]