Scientist, Process Development

Vertex has established a new research site in the Boston Seaport where research, development, and clinical manufacturing for cell and genetic therapies is 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. Investment in a research site specifically designed to advance these programs is key to Vertex's continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams 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.

Vertex is seeking a talented individual to join our Process Development /Engineering team. This group offers a dynamic, fast-paced, and highly collaborative environment making tremendous impact on our programs and for our patients. Our team focuses on bringing together the best of process design, scale-up and cutting-edge manufacturing technologies to enable the successful implementation of cell and gene therapeutics

The Process Development Scientist is a bench-focused position responsible for the design and development of a robust and scalable process for cell therapy product.

Key Responsibilities:

• Lead the design and execution of experiments for cell therapy process development, including cell banking, cell culture, harvest, and formulation

• Perform independent analysis and present to internal team as well as broader program teams

• Evaluate and implement novel technologies and equipment platforms for next generation cell therapy manufacturing processes such as cell culture, isolation, filtration, and harvest.

• Author and review technical protocols, reports, SOPs, and other technical documents.

• Lead technology transfer of new processes into GMP manufacturing

• Perform CMC development activities in support of regulatory filings

• Collaborate effectively with internal and external partner and leads projects with fully integrated team to facilitate successful outcomes.

Required qualifications:

• PhD in Stem Cell Biology, Chemical/Biochemical/Biomedical Engineering or related discipline with 0-2 years of industry experience, a MS degree with 5+ years of industry experience, or a BS degree with 6+ years of industry experience

• Hands-on experience in aseptic techniques and cell culture process development

• Expertise and hands-on experience in at least one of the following areas:1) Cell therapy process development; 2) Cryopreservation process development; 3) Media optimization and cell culture process development; 4) Cell isolation technologies (e.g. Counter current centrifugation or fluidized bed); 5) Bioreactor scale-up or scale-down development

• Working knowledge of cell analytical assays (eg. Flow-cytometry, immunofluorescence, microscopic imaging and etc.)

• Experience in design of experiments (DOE) and statistical analysis.

• Enthusiastic and self-motivated to tackle novel questions.

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