Senior Process Development Scientist - Weekend Shift, Cell Therapy

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

Job summary

Vertex Pharmaceuticals Incorporated in Boston seeks a Senior Scientist to lead cell-based process development and engineering studies for a diabetes candidate. The role includes a weekend shift leadership, robust process development, and cross-functional collaboration to advance programs toward clinical development.

You will guide a weekend shift, oversee stem cell culture work, apply DOE and statistical analyses, and ensure meticulous documentation within a GMP framework.

Qualifications

• 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.

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.

Skills

Weekend shift leadership

Team leadership

DOE / statistical analysis

Cell culture for biologics

GMP knowledge

Communication

Project collaboration

Problem solving

Time management

Education

BS in Biochemistry, Engineering, Biology or related

MS in Biochemistry, Engineering, Biology or related

PhD in Biochemistry, Engineering, Biology or related

Tools

Stirred tank reactors

Unifuge Mini

ATFs

Ambr250

Job description

Vertex Pharmaceuticals Incorporated in Boston seeks a Senior Scientist to lead cell-based process development and engineering studies for a diabetes candidate. The role includes a weekend shift leadership, robust process development, and cross-functional collaboration to advance programs toward clinical development.

You will guide a weekend shift, oversee stem cell culture work, apply DOE and statistical analyses, and ensure meticulous documentation within a GMP framework.