Sr. Director, Manufacturing Operations Viral Vectors

Company: Vertex Pharmaceuticals Inc (US)
Location: Boston
Posted on: September 17, 2020

Job Description:

In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treatand even cureseveral of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertexs continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible. Vertex, a biopharmaceutical company focused on developing a cell and gene-based therapies for multiple indications, is seeking a Senior Director of Viral Vector Manufacturing Operations to join its growing team. The full-time role will be responsible for oversight of Vertexs viral vector materials production facility and will oversee the efforts of the Manufacturing and Process Development staff. The Senior Director of Viral Vector Manufacturing Operations will work closely with the executive team, supply chain, delivery device, preclinical, and quality teams to meet program milestones. The position will be based in Boston, MA. Key Responsibilities :

* Identify, test, develop, qualify and implement technologies required to support viral vector manufacturing through oversight of Process Development Team * Work independently and with the team to develop an integrated CMC operations plan from current stage through to product launch * Manage the execution of deliverables, both short and long-term, via clearly defined milestones, and timelines. Minimize timeline deviations by clearly identifying program risks and communication of strategies * Ensure safe and compliant clinical manufacturing operations by leading the operations management team providing support to execution * Coordinate and integrate the activities of various departments to ensure alignment in scope, schedule and budget. Ensure resources are being utilized on the most impactful activities. * Ensure timely completion of activities needed for the Investigational New Drug (IND) application with the US Food and Drug Administration (FDA). Supports the filing activities as needed. * Partner with QA to develop and implement phase-appropriate Quality Systems for operations * Provide and confirm user input is used for the design and commissioning of the manufacturing facility and equipment * Lead design and start-up activities for new manufacturing site * Identify possible 3rd part CDMO for expansion of capacity * Tech transfer production technologies to third party vendors are required. * Build and develop a high-performing manufacturing team, including operations management, ensuring the right skills are added at the appropriate time during periods of rapid growth. * Provide business case justification to obtain buy-in from senior stakeholders to secure required operational resources and manufacturing capacity * Set clear objectives, monitor and report on performance of the Operations team in key areas including Quality, Safety, Delivery, and People. Mitigate and escalate risks to the appropriate level * Oversee the performance, quality and delivery of external supply partners * Develop operation's strategy to take Vertex's products to commercial production quickly and safely * Foster an inclusive, collaborative, transparent, engaged and accountable culture. Coach team for positive inter-departmental collaboration * Responsible for establishing the budget and maintaining control of costs * Drive continuous improvement activities and operational excellence, including reduction of Cost of Goods Sold (COGS) and commercial readiness * Represents manufacturing operations to senior management and external organizations and agencies

Minimal Requirements :

* PhD in Life Sciences, bio-engineering, or related discipline with minimum 15 years relevant work experience * 5+ years of demonstrated project management and change management experience in a pharmaceutical setting working with interdisciplinary and cross-cultural teams * Prior experience working with viral vector design, manufacturing and qualification technologies * Strong analytical skills, focused with business awareness and hands on to navigate execution in a highly matrixed environment * Ability to communicate effectively with a diverse range of scientists, physicians, engineers, regulatory specialists and business professionals * Experience providing clear leadership and orchestrating changes in a complex and fast-paced environment with competing priorities

Preferred Requirements:

* Experience in molecular or gene therapy product development (AAV Vector development) * Experience in manufacturing facility management * Gene Therapy Regulatory Affairs experience

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Keywords: Vertex Pharmaceuticals Inc (US), Boston , Sr. Director, Manufacturing Operations Viral Vectors, Executive , Boston, Massachusetts