VCGT is seeking a Cell TherapyProcess Development Scientist for the T1D drug substance group. The focus of this position is to drive embryonic stem cell Process Development, process characterization, and verification. The candidate will also participate in cell line development. The position will be based in Boston, MA.
- Design and execute experiments to develop a robust process with a focus on the best procedures for stem cell banking, cell thawing, and cell handling.
- Conduct stem cell expansion and directed differentiation process characterization for evaluating/verifying the process.
- Evaluate and implement novel technologies, equipment platforms, and high throughput approaches for improving cell banking and cell culture expansion processes.
- Apply Design of Experiment (DOE) principles for process optimization and process parameter evaluation.
- Support cell line development work, as required.
- Collaborate with cross-functional teams, aligning on project goals, sharing results, and fostering a collaborative working environment.
- Develop internal documentation, protocols, and reports to support regulatory filings, and the transfer of processes to the manufacturing group.
- Drive project delivery, ensuring the successful execution of Process Development initiatives and meeting project milestones.
- Bring innovation to the team, contributing novel ideas and solutions to address challenges and improve processes.
- PhD in Stem Cell Biology, Chemical/Biochemical/Biomedical Engineering, Life Sciences, or related discipline with a minimum of 0-2 years of relevant industry/postdoc work experience or a Master’s degree in a relevant field with 4-5 years of relevant industry experience.
- Strong fundamental knowledge of cell biology, human embryonic stem cell culture, and stem cell research.
- Hands-on experience in developing cryopreservation techniques and protocols.
- Knowledge of cellular, molecular, and biochemical assays to characterize stem cell culture (Flow cytometry, immunofluorescence, imaging assays, microscopy). Also, a good understanding of stem cell pluripotency and differentiation markers.
- Experience working with bioreactors and/or cell processing instruments.
- Proficient in the design of experiments (DOE) and JMP software.
- Must have a working knowledge of cGxP, theory, and practices.
- Excellent verbal and written communication skills and ability to handle multiple tasks while meeting timelines and adapting to changing priorities.
- Excellent organizational skills and high attention to detail.
- Highly self-motivated and open to weekend work if necessary.