Tome Biosciences is the programmable gene insertion company. Using CRISPR, our technologies allow us to insert any genetic sequence of any size at any location into any genome. We are writing the final chapter in genomic medicines, delivering cures to patients through cell and genome engineering.
Scientist I/II, Cell Therapy Analytical Development
At Tome, we are developing the next generation of programmable gene insertion technology. We are building an exceptional team and a work environment that is diverse, innovative, rewarding, and fun! We have the opportunity to re-write the patient story, and together, we are writing a new chapter in genomic medicines.
Our CMC Team is growing! We are seeking a Scientist I/II in Cell Therapy CMC to help build our cell therapy programs for patients in need. In this role, the individual will contribute to the analytical release and characterization strategy for our ex-vivo cell therapy programs. They will lead assay development and tech transfer activities, with a focus on flow cytometry, ddPCR, and other cell-based analytical techniques. This position will serve as a subject matter expert on a highly cross-functional, external-facing team and play a critical role in defining analytical strategy and critical quality attributes of complex cell therapy products.
Key Responsibilities
- Develop multiple analytical methods to characterize engineered iPSCs and differentiated cell types using flow cytometry, ddPCR, and other cell-based analytical techniques.
- Define tech transfer and qualification strategy for multiple analytical release test methods.
- Execute overall analytical strategy for complex cell therapy programs.
- Communicate findings and progress at a variety of settings from small team discussions to all-hands R&D meetings to external collaborator meetings.
- Document methods and maintain organized electronic records of work.
Qualifications
- PhD/MS in Biochemistry, Biology, Engineering, or other relevant science with 1-2 years of analytical development industry experience, or BS with 4-6 years of CMC analytical development industry experience.
- Experience with analytical CMC activities such as method tech transfers and assay qualifications required.
- Working knowledge of biochemical assays including ELISA, qPCR, ddPCR, western blotting, and other relevant techniques required.
- Experience supporting regulatory filings highly preferred.
- Experienced working with CDMOs highly preferred.
