Scientist II/Senior Scientist I, Analytical Development/Early QC-Molecular

Company Overview:

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.

Position Overview

We are seeking a highly motivated, detail-oriented hands-on Scientist II/Senior Scientist I to join our molecular analytical development group at the Cambridge site. This position is hands-on and requires intensive/deep knowledge and experience in molecular assay development using qPCR, ddPCR, dPCR, and other sequencing-based methodologies, as well as a strong background in data analysis and troubleshooting (Illumina-based short read and/or Pacbio/Nanopore-based long-read sequencing). This position requires a collaborative and innovative mindset to drive method development and support the early QC release and stability testing for our cell and gene therapy (CGT) pipelines. This is a great opportunity for career development and working at the frontier of CGT drug development; the ideal candidate will thrive in a fast-paced working environment, and cross-functional role supporting a range of CGT therapeutic modalities.

Key Responsibilities:

• Independently develop, optimize, qualify and hands-on execute molecular assays for the characterization, lot release, and stability testing of cell (Ex-vivo) and gene (LNP-based) therapy drug products (e.g., qPCR, ddPCR, and NGS-based methods).
• Develop and validate NGS library preparation protocols for targeted and small RNA-based sequencing applications.
• Conduct the analytical work for cell and gene drug products (DP), including preparation of reference standards, assay development, qualification and validation plans, DOE, and statistical data analysis.
• Lead the design and execution of experiments to evaluate critical assay parameters such as specificity, linearity, precision, accuracy, etc.
• Execute routine and urgent in-process and DP testing to provide timely analytical support for ongoing process development.
• Deliver solid, reproducible, and impactful results under ambitious timelines.
• Maintain thorough electronic lab notebooks and LIMS documentation records, and present findings to multi-disciplinary teams in various oral and written formats.
• Participate and present scientific findings in internal and external scientific meetings.
• Continuously learn and evaluate new assay technologies and innovate novel assays/methodologies to improve the existing analytical methods.
• Author, review, and approve protocols, SOPs, technical documents, and reports to support regulatory submissions (e.g., IND, BLA).
• Coordinate efficiently and actively with cross-functional teams, including quality control, quality assurance, process development, translational group and R&D
• Mentor, train/teach analytical techniques to junior researchers and co-op students

Qualifications

• PhD with 4+ years postdoctoral/industry experience, Master with 10+ year industry experience, in Molecular Biology, cellular biology, Biochemistry, genetics, Bioengineering, or related discipline
• Proven expertise in the hands-on development and troubleshooting of molecular assays, including:
  • Hands-on experience in PCR and recombinant DNA assembly methodology, such as Gibson Assembly/Gateway Cloning, restriction enzyme digestion, and ligation.
  • Deep knowledge of different PCR strategies and primer/probe design.
  • Hands-on experience in qPCR/ddPCR, for copy number determination, residual DNA analysis, gene expression profiling, and etc.
  • Experience in DNA/RNA isolation and NGS library construction for short- and/or long-read sequencing platforms (e.g., Illumina, PacBio, Nanopore).
  • Extensive experience/knowledge in multiple next-generation sequencing (NGS) methods.
  • Experience in the design, development, and qualification of next-generation sequencing (NGS) assays.
  • Experience/knowledge with DNA/RNA sequence analysis tools, database software, and/or basic bioinformatic scripting with R and/or Python.
  • Familiarity/knowledge with one or multiple modalities of gene and cell therapy products (e.g., ex-vivo cell therapies, AAV-based, or LNP-based products).
  • Experience/knowledge with mammalian tissue/cell culture techniques, including cell transfection and transduction, stable cell line generation, FACS, and single-cell cloning, is a plus.

• Experience/regulatory knowledge in assay development following ICH/USP guidelines.
• In-depth understanding of the mechanism of action (MOA) of gene and cell therapy products, such as ex-vivo cell and LNP-based DP.
• Highly self-motivated with the ability to own and drive projects.
• Highly self-motivated/strong hands-on enthusiasm to drive assay design, assay development and projects to clinical development stage through direct laboratory experimentation.
• Demonstrated deep scientific ability and knowledge to troubleshoot technical challenges, optimize protocols, and ensure robust and reproducible results.
• Demonstrated maturity to lead with influence, work independently, and cohesively as a team player
• Excellent oral, written, and verbal communication skills and the ability to work in a highly collaborative, fast-paced environment.

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.