Process Development Engineering Scientist

Vertex Pharmaceuticals•Boston, MA

1d•Onsite

About The Position

Vertex is seeking a talented individual to join our CGT Process Development team as a Scientist. The primary focus of this role is to lead the design and execution of process development studies for a cell-based drug candidate designed to treat diabetes. The Scientist will provide scientific and technical rigor in study design, execution, and data analysis and leveraging innovative technologies to deliver robust cell banking and hESC expansion processes. The ideal candidate has experience and understanding of embryonic stem cell biology and cell culture platforms. This is a full-time position based in our Boston, MA facilities.

Requirements

Demonstrated experience in process development, process engineering, or a related biopharmaceutical development environment with a working knowledge of GMP requirements.
Strong scientific foundation in study design, experimental execution, and data analysis, including experience with statistical principles and design of experiments (DOE).
Proven ability to collaborate across technical and operational functions, coordinating study activities, materials, sampling strategies, and execution plans.
Strong written and verbal communication skills, including technical documentation, presentation of results, and clear explanation of complex scientific concepts.
Highly organized, accountable, and effective in a fast-paced, team-oriented environment.
Authorized to legally work in the US.

Nice To Haves

Experience supporting cell culture process development, cell banking, and/or embryonic stem cell expansion desired.
Experience working with cell processing equipment such as stirred tank bioreactors, media exchange and harvesting technology [e.g., centrifuge, ATF] as well as automation [e.g., Ambr] is strongly preferred.

Responsibilities

Design, execute, analyze, and interpret studies supporting process development, optimization, robustness, and characterization activities with a focus on cell banking and hESC expansion.
Apply scientific, engineering, and Quality by Design (QbD) principles to build process understanding, establish process parameters.
Evaluate and implement novel technologies that advance process and project strategy.
Troubleshoot process challenges and contribute to manufacturing investigations using sound technical judgment and experimental data.
Clearly communicate experimental results, technical conclusions, and recommendations to project teams and stakeholders.
Ensure data integrity through timely completion of phase-appropriate documentation, including electronic lab notebooks, as well as authoring development protocols and technical reports to support technology transfers and regulatory filings.
Drive cross-functional alignment, including material planning, scheduling, sampling strategies, resource allocation, and execution planning, to ensure study readiness and timely delivery.
Lead team projects and provide mentorship, training and technical support to colleagues.
Participate in weekend work rotation with the broader team.