Associate Director, Manufacturing Operations

Vertex Inc.•Boston, MA

8d•$160,000 - $240,000•Onsite

About The Position

The Associate Director, Manufacturing Operations for Cell Therapy leads a team responsible for the execution of multi-product manufacturing operations. This role is accountable for the compliant production of cell therapy products and for the oversight, development, and training of the manufacturing team to ensure the efficient and effective delivery of therapies to patients. The role also cultivates and leverages cross-functional partnerships to identify and implement creative solutions to organizational opportunities and challenges. The Associate Director, Manufacturing Operations reports directly to the Senior Director, Manufacturing Operations and is a key member of the operational and manufacturing execution leadership team. This position is based in Boston, MA and provides oversight of three shifts supporting seven-day-a-week production at the Boston manufacturing facility. This role will partner closely with colleagues across Vertex to ensure the seamless supply of commercial cell therapy products.

Requirements

Expert knowledge of GMP manufacturing
Demonstrated ability to develop and track manufacturing metrics
Proficiency in budgeting, FTE forecasting, and production planning
Understanding of manufacturing execution systems (MES) and digital data management
Ability to identify and champion digitization opportunities
Strong coaching and mentoring capabilities
Proven ability to drive culture change and foster continuous improvement
Demonstrated success in managing quality events and maintaining compliance
Excellent presentation and communication skills, including the ability to engage senior leadership audiences
Bachelor’s degree in a scientific, technical, or engineering discipline
8+ years of experience, or the equivalent combination of education and experience
Previous experience managing day-to-day drug product manufacturing site operations
Experience selecting, building, and training a manufacturing team to operate at a high level in a cGMP-compliant environment
Experience supporting successful regulatory inspections, including FDA, EMA, and other health authority inspections

Nice To Haves

Embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends.
Bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Responsibilities

Deliver program goals by ensuring the efficient and compliant execution of all cell therapy manufacturing activities, including direct responsibility for the finished drug product (DP) manufacturing function
Build and maintain inventory to support patient needs
Lead cross-functional stakeholders to translate strategic decisions into manufacturing execution
Facilitate alignment and prioritization of manufacturing activities and objectives
Ensure products are manufactured and delivered in a safe, timely, and financially responsible manner in compliance with FDA, EMA, and other applicable global regulatory requirements
Monitor and manage resources, including FTE allocation, equipment utilization, and capacity planning
Analyze operating costs and drive continuous improvement in manufacturing efficiency
Support the implementation and optimization of digital systems to enhance manufacturing operations and data integrity
Drive digitization and automation as a functional owner by identifying opportunities for process optimization and implementation
Champion the adoption of digital tools and technologies within the manufacturing organization
Coach and develop direct reports and emerging leaders to build a strong leadership pipeline
Lead talent management and development activities, including succession planning, performance management, and career development
Attract, develop, and retain key talent across the manufacturing organization
Foster a culture of flexibility, agility, efficiency, compliance, and collaboration across teams and stakeholders
Promote a strong quality culture and ensure all activities align with GMP requirements
Maintain training excellence initiatives to ensure team competency and ongoing regulatory compliance
Present effectively to senior leadership and cross-functional teams across Vertex