Process Development Engineering Senior Scientist

Found in: Talent US C2 - 2 weeks ago

Boston, United States Vertex Full time

Job Description

General Summary:

Vertex has established a new research site in Boston Seaport 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 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.

General Summary:

Vertex is seeking a talented individual to join our Process Development team as a Senior Scientist. The primary focus of this role is to lead part of the late phase process development/engineering activities for drug substance processes for one of our key cell and gene therapy assets. The Senior Scientist will be responsible for internal process development work, optimizing cell-based bioreactor processes to increase robustness, decrease aseptic risk, increase yields and reduce the cost of goods. This role may contribute to process characterization as well as technology transfer of manufacturing processes. The position will be based in our Boston, MA facilities.

The Process Development group offers a fast-paced and high energy environment. The right candidate will be a subject matter expert in process engineering, or similar relevant field(s) and have a solid technical operations background.

Key Responsibilities:

  • Design and execute experimentation to develop robust manufacturing processes for cell therapy products and implementation to support programs in clinical development.

  • Lead and train a team of bioprocess engineers who will work closely together within a highly matrixed, cross-functional team to deliver program goals.

  • Manage and/or execute pluripotent stem cell culture and differentiation to support process development, optimization, and characterization.

  • Manage troubleshooting with high degree of complexity.

  • Document experimental procedures and results according to established guidelines. Perform statistical analysis of experimental data to determine critical process parameter ranges.

  • Communicate progress versus plan, identifying and escalating business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations, and potential solutions.

  • Collaborate effectively within departmental teams, contribute to deliverables and drive development activities in a cross-functional environment, engage on team discussions to resolve issues, and lead projects with a fully integrated team to facilitate successful outcomes.

  • Serve as an internal technical subject matter expert and support technology transfers.

  • Coordinate resources and set priorities for own team, contributing to the overall goals of the department.

  • Generate and review technical reports, regulatory filings, source documents, patents and external publications, as applicable.

Requirements:

  • BS in Biochemistry, Engineering, Biology or related discipline with 8+ years of industry experience; or an MS with 5+ years of industry experience; or a PhD with 2-5 years of industry experience.

  • Willingness to effectively lead a team of scientists/engineers, minimum of 1 year of direct management experience.

  • Experience independently conducting and directing the design, execution, analysis, and documentation of cell culture processes for biologics and/or cell therapy products.

  • Experience in evaluating and introducing novel technology platforms into process development and manufacturing.

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

  • Experience working with cell processing devices and bioreactors.

  • Working knowledge of GMP requirements.

  • Excellent verbal and written communication skills and ability to handle multiple tasks while meeting timelines and adapting to changing priorities.

  • Strong organizational skills and high attention to details.

  • Periodic weekend rotational work to support cell culture activities will be required.

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