Director, Manufacturing Operations

Job Description

General Summary:

The Director, Manufacturing Operations Cell Therapy - Drug Substance Drug Product (DSDP) leads a team in the execution of multi-product global production of investigational cell therapy products in the Type 1 Diabetes (T1D) disease areas. The role is responsible for the compliant production of cell therapy products and the oversight and training of the manufacturing team to ensure that the company effectively and efficiently delivers therapies to patients. This role is directly responsible for leading internal manufacturing teams and working with external manufacturing on the clinical production of cell therapy products. This role will also cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges. 

The Director of Manufacturing Operations DSDP reports directly to the Vice President, Cell Manufacturing and is a key member of the operational and execution leadership team. This position is based in Boston, MA with oversight of seven-day, two-shift manufacturing operations. This role is accountable for the successful manufacturing of multiple cell therapy drug substances and drug products and will partner closely with colleagues across Vertex to ensure seamless supply of all clinical batches and the commercialization of cell products. 

Key Responsibilities: 

• Responsible for the efficient and compliant functioning of the drug substance and drug product manufacturing functions 

• Forecasts, schedules, and tracks all manufacturing activities to ensure timely batch production and disposition 

• Accountable for Key Performance Indicators 

• Leads a team of cross-functional stakeholders to drive strategic decisions into manufacturing execution 

• Fosters a culture of continuous improvement and innovation while driving operational excellence through the implementation of industry best practices 

• Analyzes operating costs and drives efficiency improvement 

• Ensures consistent adherence to Good Manufacturing Practices (GMP) and regulatory requirements 

• Ensures processes are transferred and products are manufactured and delivered in a safe, timely, and financially responsible manner in compliance with FDA, EMEA, and Rest of World (ROW) regulatory requirements 

• Facilitates alignment and appropriate prioritization of manufacturing strategic objectives  

• Leadership and Development: successfully attracts, develops, and retains key talent. Builds, leads, and mentors a high-performing manufacturing team while promoting a culture of safety, collaboration, and professional growth 

• Fosters a culture of flexibility, nimbleness, efficiency and a strong compliance mindset while promoting positive collaboration among all team members, partners and key stakeholders 

• Quality Assurance and Compliance: collaborate with Quality Assurance (QA) to ensure the highest standards of product quality and compliance and ensure robust documentation and traceability for all manufacturing activities 

Education and Experience: 

• Bachelor’s Degree in Chemical/Bio Engineering, Biology, Biochemistry or related field.  Advanced degree (MS/MBA) preferred. 

• Minimum of 12 years of experience in GMP biopharmaceutical or cell therapy manufacturing with at least 5 years in manufacturing operations leadership. 

• Experience in clinical and commercial cell therapy manufacturing, biologics or vaccines in a regulatory approved manufacturing facility 

• Experience managing large manufacturing teams 

• Previous experience working in a highly matrixed environment 

• Ability to think strategically and align goals and objectives with business strategy  

• Demonstrated ability to foster a culture of safety, quality and continuous improvement in a manufacturing organization 

• Demonstrated understanding of the principles and applications associated with sterile manufacturing operations and regulations 

• Deep understanding of the science and technology underlying batch manufacturing and process analytical technologies that support manufacturing activities 

• Ability to develop, measure and manage manufacturing performance metrics 

• Excellent planning and organizational skills, with the ability to balance production, development, and continuous improvement needs 

• Expert knowledge of GMP requirements for biologics or cell manufacturing 

• Experience with scaling manufacturing processes 

• Proficient in budgeting, FTE projection and capacity forecasting 

• Solid performance