Senior Scientist I/II, Cell Therapy Assay Development
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 motivated, self-starting, and experienced scientific /technical leader with expertise in developing, qualifying, and validating a variety of assays that are critical for cell therapy product development. Working in a highly collaborative Technical Development Organization, the individual will contribute to the cell therapy programs through both knowledge/insight, hands-on work, and collaboration.
This is a scientific leadership and hands-on position where the successful candidate will contribute strategies and delivery on assays for the cell therapy drug product release and characterization. The ideal candidate will have extensive experience in multi-color flow cytometry, various immunological assays, and can collaborate effectively. This role will work closely with colleagues across the organization to advance Prime Medicine’s clinical development pipeline.
- Design, develop, optimize, qualify, and validate assays used to test cell therapy drug substances and drug products. For example, conduct and oversee all aspects of conventional and spectral flowcytometry assay methods.
- Build in-house analytical capability. Manage technology transfer to CDMOs and CTLs.
- Understand cell therapy quality attributes and suitable methodologies for testing and characterization, taking into considerations stage appropriate development needs. Recommend and implement testing methods for GxP and in-process samples.
- Deliver methods and sample characterization data. Present and communicate to teams on technical progress and data interpretations.
- Work with project teams, process development teams, analytical development colleague, and quality group to enable programs at different stages of clinical development.
- Maintain detailed and complete electronic lab notebooks and documentation records. Integrate workflows with ELN (Benchling) and LIMS to support GxP and regulatory filing requirements.
- Author, review, and approve protocols, SOPs, technical reports, and sections of regulatory submissions.
- Coordinate and work with various teams in a matrixed environment, as well as external CROs.
- PhD degree in a scientific discipline with plus 3-7 years’ relevant industrial experience or BS/MS plus 8+ years’ relevant industrial experience.
- Understand cell therapy quality attributes and suitable methodologies for testing and characterization.
- Experience in assay development, qualification, and validation in the drug development context. Extensive hand-on experiences in multi-color flow cytometry and various immunological assays.
- Demonstrated productivity and strong track records in delivery on corporate and group goals. knowledge in drug development process, CMC regulatory requirements is a plus.
- Experiences in working in multidiscipline teams and communicating complex data/decisions within department and cross functionally.
- Excellent oral and written communication skills, with the ability to influence and engage across all levels of the company and with external stakeholders, strong interpersonal skills.
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.