Process Development Engineering Principal Scientist - Medical Device

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 (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.

Reporting to the Associate Director of Process Engineering, this role will focus on the development of implantable cell encapsulation devices for delivering proprietary cells. The successful candidate will join the Process Development Team and work on process development, optimization, process scale-up, and technology transfer of novel products and processes into Manufacturing. The position will be based out of Providence, RI.

Key Responsibilities:

• Design and development of equipment, processes, and control systems, used for production and assembly of cell encapsulation devices.
• Experience with polymer joining (thermal staking, ultrasonic/ laser welding), polymer processing (injection molding, roll to plate printing), and polymer coating a plus. Identification of process technologies, developing proof of concept, prototyping, scaling up and validating for commercialization
• Manage the evaluation and selection of new equipment/technologies or modifications to existing systems to consider new processing technologies.
• Support ongoing optimization and improvement in equipment/systems/processes for long term robustness and reliability.
• Establishes operating specifications, defines process windows, and improves manufacturing techniques/processes.
• Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
• Responsible for writing and reporting of Protocols, Reports, SOP’s, and Work Instructions, as required, and conducts or coordinates testing and execution of identified activities.
• Statistically characterizes processes and implements controls to ensure repeatability and consistency.
• Design 3D CAD models, create drawings and collaborate with vendors to produce prototype and production parts. Perform engineering analyses and relevant physical testing on designs.
• Provide hands-on troubleshooting, process, and manufacturing assistance in support of a rapid development cycle and manufacturing sustainability.
• Execute assigned duties on time and within budget; proactively telegraph delays and other issues to relevant stakeholders.
• Comply with all regulatory, corporate, and Quality System policies.
• Support Deviation Management, CAPA, and Change Control activities, as required.

Required Qualifications:

• BS or MS or PhD in engineering or another relevant discipline.
• BS and 6+ years of experience (4+ years with Masters, 2+ years with PhD) working on process development and optimization within a medical device environment or other GMP regulated industry.
• Experience leading and managing high-complexity new process development initiatives from concept through execution, including process documentation and process qualification.
• Experience acting as technical project manager and coordinating cross-functional teams to achieve desired project results.
• Understanding of cGxP principles and practices and familiarization with ISO 13485, ISO 14971, and 21CFR820 is a plus. Knowledge of global cGMP requirements governing device or combination products.
• Familiarity with 3D CAD software such as Solidworks.
• A strong understanding of statistical principles is required, as are strong technical writing and presentation skills.
• Hands-on approach to problem solving, risk identification and resolution and familiarity with six-sigma Green Belt / DMAIC problem solving.
• Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.
• Sense of urgency, ability to act/escalate promptly, and transparently communicate issues to involved stakeholders and management.
• Must demonstrate strong interpersonal, presentation, and teamwork skills.

• Basic knowledge of polymer joining (thermal staking, ultrasonic/ laser welding), polymer processing (injection molding, roll to plate printing), and polymer coating.

Company Information