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    Associate Director, Manufacturing Operations - Boston, MA, United States - Vertex Pharmaceuticals

    Vertex Pharmaceuticals
    Vertex Pharmaceuticals Boston, MA, United States

    2 weeks ago

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    Description
    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

    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.

    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.

    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.
    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.
    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
    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
    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.
    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 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
    Specialist, Manufacturing Operations
    locations Boston, MA time type Full time posted on Posted 5 Days Ago Director, Packaging, Labeling Quality Operations
    locations Boston, MA time type Full time posted on Posted 30+ Days Ago External Manufacturing Operations Senior Manager

    locations Boston, MA time type Full time posted on Posted 30+ Days Ago 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 .

    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 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.

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