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Associate Director, Device Manufacturing

Company: Semma Therapeutics Inc
Location: Providence
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 treat and even cure several 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 (V.C.G.T.), 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. This role will focus on leading efforts relating to the fabrication of cell encapsulation devices for delivering proprietary cells, including establishing and qualifying processes used to make device material components and overseeing final assembly of the finished device. The Associate Director will work closely with the Device Research and Development, Process Engineering, and Aseptic Filling groups to develop and implement modifications to manufacturing processes, as required. The position will be located in Providence, R.I..

Key Responsibilities:

* Directs manufacturing efforts to ensure company facilities, equipment, and fixtures are adequately designed, built, and maintained. As part of this process, creates strategies to reduce labor costs and scrap rates, and to ensure a consistent supply of product free of defects within specified time and budget guidelines. * Manages a small team of Assembly Personnel to establish and qualify processes used in the manufacturing of V.C.G.Ts. encapsulation modalities. Has the ability to act as a tactical on-the-floor leader, while also ensuring progression of strategic manufacturing-related goals and objectives. With supervision, can manage for today while planning for tomorrow. Mentors and grows Assembly Team, as required, in line with Company Objectives. * Assumes total responsibility for maintenance of manufacturing space, including for example clean room oversight and maintenance and supply chain strategy. Experience instituting a new supply chain and other novel business systems ( e.g., L.I.M.S.) is advantageous but not required. * Authors and oversees preparation of S.O.Ps. and other quality documentation. Partners, as necessary, with other business functions to ensure Manufacturing compliance with established Company Policies, applicable Regulatory Standards, and Industry Good Practices. * Interfaces with Device Research and Development, Aseptic Filling, Program Management, Process Engineering, and External Vendors, to coordinate planning and implementation of c.G.M.P. production activities. * Sets production schedules, allocating material and manpower resources, to meet production output objectives. Strives to consistently exceed these objectives while maintaining quality. Ensures adequacy of production output to mean Corporate Objectives. * Identifies current and future raw material and production problems, and collaborates with cross-functional groups to address issues that could affect production schedules. Similarly, identifies process failure modes and works with cross-functional colleagues to evaluate and implement mitigation activities. * Establishes process controls and statistical measures of manufacturing performance and quality. * Maintains a variety of reports, records, and production documentation to reflect production schedules, performance, methods, and the like. * Establishes manufacturing objectives and metrics and consistently meets or exceeds them. Examples include, but are not limited to, scrap rate, cycle time, cost of goods sold, and the like. * Participates in establishing and modifying operational methods and processes by recommending changes in materials, equipment, and procedures. Supports execution and completion of equipment commissioning and qualification, as required. * With cross-functional stakeholders, establishes collaborations with external vendors to gain access to emerging manufacturing technologies and materials. * Provides leadership for continuous improvement to successfully enable scalability to achieve current and future quality, cost, and delivery objectives. * As a Manufacturing Representative and Subject Matter Expert, supports product and process development for new products, product changes, and other product enhancements. Experience in clean room design and construction, and the implementation of other process scale up activities, is highly advantageous.

Minimum Qualifications:

* Ph.D. or Masters in Life Sciences, Bio-Engineering, or related discipline, with more than seven years of experience in c.G.M.P. manufacturing. * Experience implementing G.M.P. Manufacturing processes for a clean-room environment, including involvement in technology transfer. * Ability to communicate effectively with a diverse range of scientists, engineers, and business professionals. Must be able to mentor less experienced colleagues to drive consensus in achieving achieve Corporate Objectives. * Demonstrated excellence in planning, executing, and analyzing manufacturing activities. * Experience managing a small, dynamic group with shifting priorities. * With a Project Management Organization, ability to manage activities and forecast development work through timelines and budgets that meet Corporate Goals. * An ability to exemplify the highest standards of Corporate Etiquette and manage a small team through substantial organizational change is required.


Keywords: Semma Therapeutics Inc, Providence , Associate Director, Device Manufacturing, Executive , Providence, Rhode Island

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