Associate Director, Manufacturing Operations

Job Description

General Summary:

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.

Key Duties and 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

Knowledge and Skills:

• 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

Education and Experience:

• Bachelor’s degree in a scientific, technical, or engineering discipline
• Typically requires 12 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

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who 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.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    On-Site: 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-Hybrid
 

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]