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 II, mRNA (Process 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 an opportunity to re-write the patient’s story, and together, we are writing a new chapter in genomic medicines.
Our CMC Team is growing! Reporting to our Director, Manufacturing & Process Development, we are seeking a Scientist II, mRNA (Process Development) to join our organization. This position will be responsible for executing process development for mRNA production and will play a critical role in successfully developing manufacturing processes that deliver a quality product. The ideal candidate will have technical expertise in chromatography and TFF, and experience in scale-up, tech transfer, and GMP principles. Primarily, this role will focus heavily on downstream purification of mRNA, secondary responsibilities will contribute to development and scale-up of the upstream in vitro transcription process.
Key Responsibilities
- Lead and perform hands-on work in mRNA purification process development
- Develop novel purification strategies for improved mRNA yield and purity
- Employ engineering principles to define process parameters, ranges, specifications, and control strategies for robust, scalable, and highly productive processes
- Execute end-to-end unit operations including in vitro transcription, capture/polishing chromatography, and filtration to support internal material needs
- Apply QbD principles and drive scale-up and scale-down models for mRNA drug substance production
- Communicate results through presentations and authorship of technical reports
- Collaborate within the PD group and across the organization to achieve project and corporate goals
Qualifications
- Ph.D. in Chemical/Biomedical Engineering, Biochemistry, or a related discipline with 2+ years relevant industrial experience, M.S. with 6+ years, or B.S. with 8+ years
- Technical expertise in chromatography required
- Experience with statistical methods for design and analysis of experiments
- Demonstrated ability to be self-motivated, proactive, and capable of generating results in a fast-paced cross-functional environment
- Knowledge mRNA purification from IVT reactions including chromatography and filtration (tangential/normal flow) methods
- Working knowledge of in vitro transcription of mRNA and mRNA process analytics a plus
- Excellent interpersonal and communication skills (both verbal and written)
- Recognized scientific leadership as evidenced by journal articles, patents, or presentations
