Process Development Engineering Senior Scientist

Vertex Inc.•Boston, MA

3d•$123,200 - $184,800•Onsite

About The Position

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 the execution of process development and engineering studies for a cell-based drug candidate designed to treat diabetes. The Senior Scientist will be responsible for internal process development work, including process robustness and characterization studies, and may support manufacturing investigations. Importantly, the Senior Scientist will lead a weekend shift team to provide continuity for on-going studies over weekends and holidays. This is a full-time weekend and holiday shift position 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.

Requirements

Enthusiastic about maintaining a weekend and holiday shift schedule.
Willingness to effectively lead a team of scientists/engineers, minimum of 1 year of direct management experience.
Strong communicator with experience collaborating on projects and managing changing priorities.
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.
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 detail.

Nice To Haves

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.

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.