Cell Therapy Process Engineering, Associate Director
About the Job
In June 2019, Vertex announced the establishment of a new research site in the Boston area 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.
VCGT is seeking a Cell Therapy Process Development Engineer/Scientist to join its growing team. The role will be responsible for development of Vertex’s cell therapy production platforms and will participate in development of advanced cell processing and culture systems. The Cell Therapy Process Development Engineer will work closely with the Research and Development, Manufacturing and Quality Systems teams to meet program milestones. The position will be based in Boston, MA and may require periodic travel to Vertex’s device production laboratories in Providence, RI,
- Develop robust, scaled platform for pluripotent stem cell expansion/directed differentiation and other cell types
- Develop cell isolation, purification, separation and formulation protocols and technologies in support of product development from clinical to commercial scale.
- Apply DOE/QBD principals to process characterization, establish process parameters, and contribute to CMC sections of regulatory filings
- Lead technology transfer to manufacturing and provide training for GMP production
- Coordinate and integrate the activities of various departments to ensure alignment in scope, schedule and budget. Ensure resources are being utilized on the most impactful activities.
- Ensure timely completion of activities needed for Investigational New Drug (IND) applications with the US Food and Drug Administration (FDA). Support the filing activities as needed.
- Partner with QA to develop and implement phase-appropriate Quality Systems for operations
- Provide and confirm user input is used for the design and commissioning of the manufacturing facility and equipment
- Identify raw materials and support the establishment of raw materials specifications.
- PhD in Life Sciences, bio-engineering, or related discipline with minimum 8 years of relevant industrial work experience or Master’s degree with 12 years of industry experience
- 3-5 years management experience preferred
- 5+ years of demonstrated process development experience in a bio-pharmaceutical setting working with interdisciplinary and cross-cultural teams
- Experience working with cell processing devices and bioreactors
- Ability to communicate effectively with a diverse range of scientists, engineers, regulatory specialists and business professionals
- Experience in stem cell expansion and differentiation
- Demonstrable productivity in the form of patents, publications and/or presentations.
- Prior experience with 50+ liter mammalian cell culture bio reactors
- Experience with cell separation/selection devices
- Strong knowledge of GMP requirements for cell therapy products.