Senior Scientist​/Principal Scientist, mRNA Production, Process & Analytical Development

Typewriter is authoring a new chapter in durable genetic medicine for cancer and other life-threatening diseases.

We insert a durable, full working gene into a genomic safe-harbor site using only RNA, delivered by lipid nanoparticles (LNPs) without double-stranded DNA breaks. The Typewriter approach makes genetic medicine safer, repeatable, and accessible to more patients.

We are seeking a highly motivated and talented Senior Scientist / Principal Scientist to be a key member of the mRNA team to lead the production, process development, and analytical characterization of in vitro transcribed (IVT) mRNA for our preclinical animal studies. This is a hands-on, on-site laboratory role, with approximately 80% lab-based work and 20% dedicated to experiment planning and CDMO oversight.

While supervising a small team, this individual will assume technical leadership of and be actively engaged in the production, purification, and process optimization of mRNA IVT, and in developing the analytical methods that define product quality. This individual will also interface with cross-functional teams including LNP formulations and in vivo pharmacology to advance pipeline programs. The ideal candidate will have a proven ability to produce and purify mRNA at scale, develop robust and reproducible processes, and establish the analytics that ensure batch-to-batch consistency.

The candidate is expected to be a strong collaborator who enjoys scientific discovery, has a passion for working on cutting-edge technology, and can communicate effectively in a fast-paced, dynamic, and interdisciplinary environment.

• Produce NHP-scale mRNA, including plasmid scaleup, template linearization, IVT, and purification.
• Design, characterize, and optimize IVT and purification operations (e.g., DNase treatment, dsRNA removal, chromatography, TFF) for yield, purity, and integrity.
• Develop Design of Experiment (DOE) principles for process development and related activities.
• Develop and qualify analytical methods for mRNA identity, integrity, purity, capping efficiency, poly(A), and residuals (e.g., dsRNA, residual DNA and protein).
• Establish specifications, in-process controls, and stability programs appropriate to program stage.
• Manage external CDMOs for sourcing, scale-up, technology transfer, and capability building.
• Maintain meticulous documentation of all experimental data, procedures, and protocols.
• Review and analyze data and be able to present and explain across the functional teams.
• Collaborate with a team of scientists to creatively solve problems and drive innovation; supervise and inspire small mRNA production team.
• Maintain high standards for scientific integrity and accountability.
• Communicate across groups and support project teams.

• PhD in chemistry, biochemistry, molecular biology, chemical engineering, bioengineering, pharmaceutics, or related discipline with at least 4 years of relevant industry experience (6+ years for the Principal level), MS (in the same subject areas as above) with at least 8 years of relevant industry experience, BS (in the same subject areas as above) with at least 10 years of relevant industry experience
• Hands-on experience with mRNA IVT, and with developing mRNA purification processes (e.g., chromatography, TFF) is required
• Hands-on experience with analytical methods for mRNA (e.g., capillary electrophoresis/fragment analysis, HPLC, UV-Vis, and plate-based fluorescence assays, and dsRNA quantitation) is required
• Hands-on experience with production scales for NHP studies or larger is required
  
  Experience with technology transfer to CDMOs and phase-appropriate CMC/IND-enabling activities is preferred
• Able to conduct self-directed research and thrive in a…