In June 2019, Vertex announced the establishment of new research sites in Boston and Providence 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 Vertex's 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.
Reporting to the Director of Process Engineering, this individual will be responsible for developing and executing the Process Engineering strategy relating to the design and development of medical devices intended to encapsulate a novel cell therapy for the treatment of Type 1 Diabetes. In addition, he/she will provide leadership in overseeing process validation, technology transfer, and implementation of continuous improvement initiatives. It is also expected that the incumbent will provide Engineering support to other groups, including R&D and manufacturing, as required. The position is based out of Providence, R.I.
- Develop process optimization/scale-up strategy and drive engineering initiatives to meet department and organizational objectives as the company prepares to begin clinical development.
- Lead a team of process engineers involved in the design and development of equipment, processes, and control systems, used for production and assembly of cell encapsulation devices.
- Provide technical engineering expertise within multiple areas of responsibility, including engineering, validation, packaging, sterilization, and equipment/system development.
- Ensure the development of detailed project plans and timelines, including resource and equipment needs, budgets, outside contractors, purchased equipment, and materials. Present to Senior Management as required.
- Manage the evaluation and selection of new equipment/technologies or modifications to existing systems to consider new processing technologies or strategies. This may include economic, quality, and productivity analysis.
- Responsible for ongoing optimization and improvement in equipment/systems/processes for long term robustness and reliability.
- Establishes operating equipment specifications, defines process windows, and improves manufacturing techniques/processes.
- Provide technical engineering oversight from development to the transfer and implementation and routine operation of process equipment/systems.
- Statistically characterizes processes and implement controls to ensure repeatability and consistency.
- Support deviation management, CAPA, and change control activities, as required. Serve as process S.M.E. to Quality, Supply Chain, Manufacturing, and other Functions. Support manufacturing investigations, including OOS's., OOT's., RCA's., etc.
- Authors protocols, pFMEA's, equipment and process documentation, SOP's, and work instructions in compliance with VCGT quality management systems and industry regulations.
- Coordinates activities of the department and with other functional leaders.
- Performs other duties as assigned.
- Bachelor's or Master's Degree in engineering or another relevant discipline.
- Minimum of 10 years of experience working within a medical device environment, with a minimum of 4 years in a managerial capacity. Experience with device-biologic combination products is highly desirable.
- Proven experience with Process Development, Process Optimization, Scale-up, and Technology Transfers.
- Strong understanding of Process Instrumentation and Controls
- Comprehensive knowledge of Design Control and Risk Management, including experience using F.M.E.A. analyses, is strongly advantageous.
- A thorough understanding of c.G.x.P principles and practices, ISO 13485, ISO 14971, and 21C.F.R.820.
- A strong understanding of statistical principles is required, as are strong technical writing and presentation skills.
- Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.
- Must demonstrate strong interpersonal, teamwork, and team management skills.
- Ability to organize a team through organizational changes
Posting ID: 590530040Posted: 2020-12-01