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Associate Director Process Engineering

Company: Vertex Pharmaceuticals Inc (US)
Location: Providence
Posted on: January 12, 2021

Job Description:

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 the implementation of 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, automation, 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.Key Responsibilities:

  • Lead Process Engineering initiatives, contribute to Process Development strategy and manage Engineering Resources to achieve Technical Operations Objectives. Will have responsibility for hands-on development of processes relating to polymer synthesis, molding, assembly, packaging, and sterilization of medical devices.
  • Lead a team of process engineers involved in the design and development of equipment, processes, and control systems, used for the production and assembly of cell encapsulation devices.
  • 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, automation initiatives, and modifications to existing systems to consider new processing technologies or strategies. This may include economic, quality, and productivity analysis.
  • Manage all aspects of Product Transfer, from the process establishment stage for early-stage clinical manufacturing through commercial c.G.M.P. production, ensuring that project objectives and timelines are achieved, and work is thorough and well-coordinated.
  • Establish robust process performance across all clinical and commercial manufacturing lines, including process development, process improvement, and maintenance of process excellence. Lead process monitoring, continuous improvement, and lifecycle management initiatives. Establish K.P.Is. and manage performance gaps.
  • Collaborate with Research and Development, Manufacturing, Quality, Analytical Development, and Supply Chain to support a phase-specific "design for manufacturability" mentality and manufacturing performance. Lead process optimization activities.
  • Review and/or draft internal Batch Records, Engineering Protocols and Reports, and other Quality System Documentation.
  • Support Deviation Management, C.A.P.A., and Change Control activities, as required. Serve as process S.M.E. to Quality, Supply Chain, Manufacturing, and other Functions. Support manufacturing investigations, including O.O.Ss., O.O.Ts., R.C.As., etc..
  • Represent the department on cross-functional teams, establish priorities, and provide updates to Senior Management on all Technology Transfer and Technical Operational activities.
  • Execute assigned duties on time and within budget; pro-actively telegraph delays and other issues to relevant stakeholders.
  • Comply with all regulatory, corporate, and Quality System policies and complete other projects and/or assignments as required.Requirements:
    • B.S. or M.S. in engineering or another relevant discipline,
    • Minimum of 8 years of experience working within a medical device process development environment, with a minimum of 3 years in a managerial capacity. Experience with device-biologic combination products is highly desirable.
    • Ability to organize a team through organizational changes.
    • Proven experience with Process Development, Process Technology Transfer, Technical Operations, and Lifecycle Management.
    • Experience validating manufacturing processes is required. Knowledge and experience in utilizing risk-based approaches to validation process development and validation are highly advantageous.
    • Comprehensive knowledge of Design Control and Risk Management, including experience using F.M.E.A. analyses, is strongly advantageous.
    • Familiarization with ISO 13485, ISO 14971, and 21C.F.R.820. Knowledge of global GMP requirements governing device or combination products.
    • A strong understanding of statistical analyses is required, as are strong technical writing and presentation skills.
    • Sense of urgency, ability to act/escalate promptly, and transparently communicate issues to involved stakeholders and management.
    • Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.
    • Knowledge of business applications such as OPM (Oracle), QDocCS, Trackwise/Veeva, MS Office.
    • Must demonstrate strong interpersonal, presentation, and teamwork skills.#LI-BS1

Keywords: Vertex Pharmaceuticals Inc (US), Providence , Associate Director Process Engineering, Engineering , Providence, Rhode Island

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