Process Dev Engineering Scientist

Job Description General

Summary:

Vertex is seeking a talented individual to join our Process Development team as a Scientist. The primary focus of this role is to lead and manage the execution of development studies for a cell-based drug candidate designed to treat diabetes. This is a full-time position based in our Boston, MA facilities, with occasional weekend work required. The Process Development group offers a fast-paced and high energy environment.

The right candidate will be a subject matter expert in bioprocess engineering and have a solid technical operations background.

• Design and execute experiments to develop robust manufacturing processes for cell therapy products and implement to support programs in clinical development.
• Mentor team of bioprocess scientific associates who will work closely together within a highly matrixed, cross-functional team to deliver program goals.
• Communicate effectively between departmental teams to develop plans for ongoing studies, including understanding experimental goals, developing schedules, and delegating work to the team.
• Develop expertise in pluripotent stem cell culture and differentiation to support process development, optimization, and characterization.
• Use engineering principles to develop solutions for technical issues with high degree of complexity.
• Document experimental procedures and results according to established guidelines in electronic lab notebook.
• Perform statistics and advanced analytics on experimental data.
• Communicate progress against plan, identifying and escalating business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations, and potential solutions.
• Collaborate effectively within departmental teams, engage in team discussions to resolve issues, and lead projects with a fully integrated team to facilitate successful outcomes.
• Coordinate long-range priorities and resources for own team, contributing to the overall goals of the department.
• Generate and review protocols and technical reports.

• Expertise in cell culture process development for biologics and/or cell therapy products, including the independent design, execution, analysis, interpretation, and documentation of studies.
• Expertise in bioreactor process control, SCADA systems, bioreactor design and scale up principles.
• Proficiency in the application of online and inline analytical tools, bioreactor feeding technologies, and unit operations such as continuous centrifugation, buffer exchange, and filtration systems.
• Experience with a range of cell processing devices and bioreactor platforms/scales such as spinner flasks, fixed bed reactors, stirred tank reactors, and AM  systems.
• Strong verbal and written communication skills, with excellent organizational skills and attention to detail.
• Demonstrated ability to collaborate effectively on cross-functional projects, manage multiple priorities, and adapt to changing timelines and business needs.
• Proficiency in design of experiments (DOE) and statistical analysis using statistical tools such as JMP.
• Proficiency in aseptic technique.
• Working knowledge of GMP requirements and their application to process development activities.
• Experience with pluripotent stem cell culture in both adherent and suspension formats preferred.

• Bachelor's degree in Chemical Engineering, Biomedical Engineering, Biology or related discipline.
• Requires a Bachelor's degree and 6+ years of experience or a Master's degree and 3+ years of experience or a PhD and 0-3 years of experience, or the equivalent combination of education and experience.

$104,000 - $156,000

The range provided is based on what we believe is a…