Associate Director, Manufacturing Operations - Devices

Boston, MA, United States

Associate Director, Manufacturing Operations - Devices page is loaded Associate Director, Manufacturing Operations - Devices Apply locations Boston, MA time type Full time posted on Posted 30+ Days Ago job requisition id REQ-21661 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

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].

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Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency .

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com  or follow us on Facebook , Twitter/X ,  LinkedIn ,  YouTube  and  Instagram .

The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives.

Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.

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