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.
Principal Scientist/Associate Director, Process Development, Cell Therapy
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 an opportunity to re-write the patient story, and together, we are writing a new chapter in genomic medicines.
Our CMC Team is growing! Initially reporting to our Cell Therapy CMC Director, we are seeking a Principal Scientist/Associate Director in process development with a focus in cell therapy to join our organization. This initial hire will establish key core competencies in addition to playing a vital role in building the CMC organization with the ability to directly influence the recruitment of the eventual head of process development across all modalities at Tome to whom which this candidate will then report to. This position will be responsible for leading assay development activities for Tome’s cell therapy pipeline and will play a critical role in driving critical CMC activities, interfacing cross-functionally with key stakeholders within Tome, management and mentoring of junior level scientists, supporting any regulatory filings, and acting as a key CMC leader at Tome.
- Oversee and drive the process strategy for release and characterization for all cell therapy programs at Tome.
- Leads from the bench; key lab personnel to setup foundational functionality with future support from junior team members.
- Independently authors method documents, protocols, and reports.
- Analyze data with available tools, interpret results, and present the data to internal and external stakeholders.
- Provides guidance as a process development SME and help to build a knowledge base within the group and across the company.
- Effectively collaborates cross-functionally to facilitate the timely success of projects and meet organizational goals.
- Ph.D. degree, master’s degree, or bachelor’s degree in biomedical sciences (e.g. immunology, molecular and cell biology, oncology, genetics, pharmacology, biomedical engineering, etc.).
- A minimum of 4 years working full time in process development in an industrial setting.
- A minimum of 2 years of management experience leading cell therapy process≈ development activities.
- In-depth biological knowledge and technical experience in various cell therapy modalities (CAR-T, HSC, NK, Treg, iPSC, etc.). High priority placed on iPSC experience.
- In-depth understanding and experience in complex in complex process development campaigns with special emphasis on iPSC and/or T cell cell-based systems. Hands-on experience in unit operations including: wash/concentration, selection, differentiation/culture, payload delivery, formulation, fill/finish, and cryopreservation.
- Well-versed in manufacturing tools including but not limited to offerings from: Miltenyi, Cytiva, Fresenius Kabi, Thermo Fisher, and Lonza.