Prime Medicine was founded to bring the promise of gene editing to patients. We use Prime Editing, a next-generation technology that can “search and replace” to restore normal genetic function almost anywhere in the genome. Prime Editing searches to find the precise place in the genome to edit and replaces the segment of faulty DNA with a correct copy of DNA. A single Prime Editor can correct the individual mutations found across patients, meaning Prime Editing can potentially address more than 90 percent of known disease-causing genetic mutations.
We envision a world where this technology can cure, halt, and ultimately prevent genetic diseases, providing lifelong benefit to patients. Prime Medicine offers the opportunity to shape the future of gene editing and transform how medicines are used to treat disease. Realizing the promise of Prime Editing requires a talented team with diversity of viewpoints and expertise. We’re building a group of dedicated, scientifically curious individuals who are passionate about helping patients live longer, healthier lives.
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.