Job Description

General Summary:

The Associate Director, Manufacturing Operations This role enables the commercial manufacturing of combination devices to support our ongoing programs. They will support the implementation of commercially capable processes for manufacturing. S/he will understand device manufacturing, including working with device development and clinical manufacturing to enable commercial manufacturing at various scales.

Key Duties and Responsibilities:

• Work with colleagues across Vertex, including Process Development and Vertex Cell and Gene Therapy, Device Groups, Pharmaceutical Sciences, Packaging, and Commercial to bridge device manufacturing technology from development into commercialization and commercial manufacturing.

• Work with contract development and manufacturing organizations (CDMOs) on tech transfer, process installation, qualification, and ongoing manufacturing oversight of regenerative medical devices.

• Ensuring ongoing technical support is supplied for all manufacturing processes internally and/or at contract manufacturing sites and directing global initiatives and cross-functional teams of subject matter experts in manufacturing.

• Ensuring ongoing support for combination device development programs during various stages of the program lifecycle.

• Provides visible leadership in one or more technical areas.

• Assists in the creation of department goals.

• Partner with late-stage product development teams and contribute to regulatory filing activities to ensure the robustness of the commercial manufacturing process.

• Develops and executes manufacturing strategies for Technology Transfers and Process Validations, including formulating strategic master plans, protocols, and reports.

• Coordinates activities and leverages best practices across multiple projects and suppliers.

• Champions high-impact cross-functional initiatives and maintains strong relationships with key internal and external stakeholders.

• Evaluates process performance using statistical process controls to identify and lead continuous improvement activities throughout the product lifecycle.

• Drives resolution of complex manufacturing issues and leads global expansion activities throughout the product lifecycle.

Knowledge and Skills:

• Deep understanding of the science and technology underlying combination device, development and manufacturing

• Demonstrated understanding of the principles and applications associated with manufacturing operations, maintenance, and engineering

• Knowledgeable in the requirements of Quality Systems, Investigation management, writing review and approval of batch records, SOPs

• Outstanding interpersonal, verbal, written, and presentation skills

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

• Strong understanding of budgeting/expense management with a basic understanding of financial and accounting practices

• Excellent team management skills

Education and Experience:

• BS or MS or PhD in engineering or another relevant discipline.

• BS and 8+ years of experience (6+ years with Masters, 4+ years with PhD)

• Previous Experience working on process development and optimization within a medical device environment or other GMP-regulated industry.

Company Information