Cell Therapy Process Development Senior Scientist (Weekend)

Vertex Pharmaceuticals Incorporated; Boston (MA); On-site; USD 123,000 - 185,000; Full time

Job summary

Vertex is seeking a Senior Scientist to lead process development and engineering studies for a cell-based drug candidate. Based in Boston, MA, you will manage weekend shift bioprocess teams and drive robustness and characterization studies across clinical programs.

You will design experiments, supervise pluripotent stem cell culture, perform DOE and statistics, and collaborate in a matrixed team to deliver program goals while ensuring GMP compliance and thorough documentation.

Qualifications

• Weekend shift leadership experience preferred.
• Minimum of 1 year direct management experience.
• Strong communicator with cross-functional collaboration 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 design of experiments (DOE) and statistical analysis.
• Pluripotent stem cell culture experience in 2D and/or 3D preferred.
• Experience working with cell processing devices and bioreactors such as stirred tank reactors, Unifuge Mini, ATFs, and Ambr250.
• Working knowledge of GMP requirements.
• Excellent verbal and written communication skills and ability to handle multiple tasks while meeting timelines.
• Strong organizational skills and high attention to detail.

Responsibilities

• Design and execute experimentation to develop robust manufacturing processes for cell therapy products and implementation to support programs in clinical development.
• Lead process robustness and characterization studies to support process understanding and clinical development goals.
• Lead and train the weekend shift team of bioprocess associates and engineers who will work closely together within a highly matrixed, cross-functional team to deliver program goals.
• Communicate effectively to develop reliable weekend coverage plans for ongoing studies, including understanding experimental goals, developing schedules, and delegating the work to the weekend shift team.
• 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.
• 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.

Education

BS in Biochemistry, Engineering, Biology or related discipline

MS in Biochemistry, Engineering, Biology or related discipline

PhD in Biochemistry, Engineering, Biology or related discipline

Job description

Vertex is seeking a Senior Scientist to lead process development and engineering studies for a cell-based drug candidate. Based in Boston, MA, you will manage weekend shift bioprocess teams and drive robustness and characterization studies across clinical programs.

You will design experiments, supervise pluripotent stem cell culture, perform DOE and statistics, and collaborate in a matrixed team to deliver program goals while ensuring GMP compliance and thorough documentation.