Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.
Prime Medicine is currently progressing a diversified portfolio of eighteen programs initially focused on genetic diseases with a fast, direct path to treating patients or with a high unmet need because they cannot be treated using other gene-editing approaches. Over time, the Company intends to maximize Prime Editing’s therapeutic potential and advance potentially curative therapeutic options to patients for a broad spectrum of diseases. For more information, please visit www.primemedicine.com.
We are currently seeking a skilled and highly motivated Scientist II / Senior Scientist I with expertise in analytical development for mRNA in the context of mRNA-LNP drug products. In this position, you will join the growing Analytical Development team and play a key role in shaping the foundation of Prime’s analytical development capabilities by developing methods and performing testing to support programs utilizing mRNA and LNP. This is a hands-on role where the successful candidate will have strong experience with analytical assay development of mRNA and LNPs. The ideal candidate will also be comfortable as a member of a cross-functional team that works closely with the process development, pharmacology, formulation, and quality teams to advance the Prime Editing therapeutic product pipeline.
- Oversee all aspects of analytical development for mRNA drug substance, including routine sample analysis, release testing, new analytical method development, method qualification, and stability testing
- Develop analytical characterization methods and perform testing for mRNA drug substance and mRNA-LNP drug product
- Support mRNA and LNP process development through development of analytical methods and performing testing in close coordination with the mRNA process development team
- Devise internal and external testing strategies and manage relationships between Prime and CTLs/CDMOs, including analytical method tech transfers, to meet program timelines
- Supervise and manage work of associate scientist(s)
- Stay informed on current regulatory guidance for mRNA drug development and serve as the subject matter expert in mRNA regulatory strategy
- Stay current with latest mRNA analytical technologies and implement new platforms to augment Prime’s mRNA analytical capabilities
- Maintain electronic lab notebook and support maintenance of mRNA database following data integrity principles and practices
- Author, review, and approve protocols, SOPs, technical documents, and reports in support of regulatory submissions
- PhD or MS in Chemistry, Analytical Chemistry, Chemical Engineering, Biochemistry, or related discipline
- 1-3+ (PhD) or 5+ (MS) years of experience with a preference for industry experience
- Strong foundation in mass spectrometry and/or separation sciences
- Experience with characterization of mRNA using analytical techniques such as HPLC/UPLC, LC-MS, LC-MS/MS, UV-Vis, sequencing methods, and/or capillary electrophoresis
- Experience with characterization of lipids/LNP using ELS/DLS, LC-UV/CAD/ELSD, sequencing methods, capillary electrophoresis, and/or fluorescence spectroscopy is a plus
- Ability to troubleshoot complex problems and successful track record of identifying and onboarding new assays/technologies for mRNA
- Knowledge of statistical design of experiments (DoE) and analysis is a plus
- Knowledge of nucleic acid chemistry and biology is a plus
- Knowledge of NGS-based workflows and prior experience with genome editing is a plus
- Experience with GMP and GLP regulations is a plus
- Highly self-motivated, driven, can-do, make it happen attitude with ability to own and drive projects
- Strong collaborator with cross-functional teams and external partners
- Resilient, adaptable, and capable of continuous learning
- Highly organized and detail-oriented
Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.