Senior Director, Manufacturing Technical Operations - Devices

Company: Vertex Pharmaceuticals
Location: Boston
Posted on: January 15, 2021

Job Description:

Senior Director, Manufacturing Technical Operations - Devices Job Description The leader of the Manufacturing Technical Operations Devices Team will be responsible for enabling the commercial manufacture of devices to support our cellular therapies. They will oversee the implementation of commercially capable processes for manufacturing. This leader will have an excellent understanding of device manufacturing, including working with device development and clinical manufacturing to enable commercial manufacturing at various scales. As a leader of this critical effort, they will be able to foster a strong attitude of collaboration and work closely with all other groups within the organization. This role will report to the VP of Technical Operations/Vertex Cell and Genetic Therapies unit of Vertex Pharmaceuticals within the Commercial Manufacturing and Supply Chain.-- Key Responsibilities: Work with colleagues across Vertex, including Process Development and Vertex Cell and Gene Therapy, Device Group, to bridge device manufacturing technology from development into commercialization and commercial manufacturing Serve as Subject Matter Expert on device manufacturing, supporting development, manufacturing, investigations, process improvements, validations and support regulatory filings, technical documents, and inspections Work with contract development and manufacturing organizations (CDMOs), on tech transfer, process installation, process qualification, and ongoing manufacturing oversight of cell encapsulation devices Build and lead a team of scientists and engineers to support devices and translate business requirements into process changes in support of product and manufacturing strategies Ensuring ongoing technical support is supplied for all manufacturing processes both internally and/or at contract manufacturing sites and directing global initiatives and cross-functional teams of subject matter experts in manufacturing. Driving innovation and communication of latest industry trends and best practices for process design and manufacturing to ensure consistency. Minimal Requirements: Ph.D. in Bio-engineering, Engineering, mechanical or industrial engineering At least 10 years of experience in implementing device systems in cGMP manufacturing. Demonstrated knowledge of biomaterials, implantation systems, devices, or tissue remodeling products. Experience establishing and maintaining robust validation and process control strategies. Experience with complex regulatory filings, including initial IDE, BLA and post-approval regulatory activities. Several years leading and managing a team of dedicated scientists and technicians Strong cross functional leadership skills including refined verbal and written communication skills Strong engineering skills, including facility fit and process engineering assessment into different facilities. Preferred skills: Experience with implantable surgical devices Experience with allogeneic or autologous cell therapy #LI-MH1 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 ApplicationAssistance@vrtx.com. Posted 2 Days Ago Full time REQ-10193 About Us Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has three approved medicines that treat the underlying cause of cystic fibrosis (CF) - a rare, life-threatening genetic disease - and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational medicines in other serious diseases where it has deep insight into causal human biology, such as sickle cell disease, beta thalassemia, pain, alpha-1 antitrypsin deficiency, Duchenne muscular dystrophy and APOL1-mediated kidney disease. 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, UK. Additionally, the company has research and development sites and commercial offices in--North America,--Europe,--Australia--and--Latin America. Vertex is consistently recognized as one of the industry's top places to work, including nine consecutive years on--Science magazine's--Top Employers list and top five on the 2019 Best Employers for Diversity list by--Forbes. For company updates and to learn more about Vertex's history of innovation visit-- www.vrtx.com --or follow us on-- Facebook ,-- Twitter ,-- 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.

Keywords: Vertex Pharmaceuticals, Boston , Senior Director, Manufacturing Technical Operations - Devices, Executive , Boston, Massachusetts