Senior Scientist, In Vitro Efficacy

About Scribe:

Scribe Therapeutics is a clinical-stage biotechnology company engineering CRISPR-based technologies into purpose-built in vivo genetic medicines designed to become standard of care treatments for patients suffering from highly prevalent diseases, starting with cardiometabolic disease. Leveraging its CRISPR by Design™ approach and nature’s blueprint for improved cardiovascular health, Scribe’s initial programs focus on addressing the key drivers of ASCVD such as elevated LDL-C, lipoprotein(a), and triglycerides. The company’s lead candidate, STX-1150, is a novel liver-targeted therapy designed to epigenetically silence the PCSK9 gene and reduce LDL-C levels without inducing permanent DNA changes. To broaden and accelerate the impact of its engineered CRISPR technologies for patients, Scribe has formed strategic collaborations with world-leading pharmaceutical companies including Sanofi and Eli Lilly. Co-founded by Nobel Prize winner Jennifer Doudna and backed by leading life sciences investors, Scribe is advancing scalable, transformative, and preventative genetic medicines with the goal of improving outcomes and democratizing access to the protective effects of beneficial human genetics.

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Position Summary:

We are seeking a highly creative, passionate, and motivated individual to join us in our quest to develop the next generation of CRISPR-based therapeutics. The current opportunity is for a Senior Scientist I/II, In Vitro Efficacy to advance our ongoing efforts to engineer highly active and specific CRISPR enzymes. The successful candidate will serve as the analytical lead responsible for designing, validating, and scaling potency assays essential to the development of our next-generation CRISPR-based genetic medicines as they advance toward the clinic. The successful candidate will play a key role in characterizing CRISPR systems that advance our therapeutic programs, with a focus on building and maintaining end-to-end cell culture-based potency assays. The successful candidate will work collaboratively across interdisciplinary teams, including protein engineering, process sciences, computational biology, NGS, and disease-area experts. The successful candidate should bring strong experience in cell culture and synthetic biology, along with a passion for developing innovative tools to address the challenges of this emerging frontier in genetic medicine.

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Competencies:

Assay Development

Cell Cultures

Lipid Nanoparticles

Data Analysis

SOP writing

Prism and PLA software

Biostatistics

Process Science

Presentation Skills

Collaboration

Engaging with CROs

Lab Safety

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Key Duties / Responsibilities / “What you’ll do”:

• Pipeline Support & Assay Development: Identify, design, optimize, qualify, and validate robust, fit-for-purpose, end-to-end cellular and molecular potency assays and Standard Operating Procedures (SOPs) for core therapeutic assets, and ensure regulatory alignment.
• Potency Strategy & Product Development: Interface directly with development teams to define potency specifications, support drug substance and drug product lot release, and guide stability testing regimens.
• Method Transfer & External Partnerships: Lead method transfer of established bioassays to external CROs/CDMOs. Direct operational monitoring, assay qualification, validation, and lifecycle management to safeguard data integrity, maintain clinical program timelines, and ensure regulatory compliance.
• Cross-Functional Collaboration: Partner closely with Protein Engineering, Molecular Biology, Computational Biology, Process Sciences, and Disease Biology teams to feed potency insights back into early-stage engineering and pipeline decision-making.
• Technical Documentation & Mentorship: Author high-quality technical reports, SOPs, protocol qualification/validation documents, and regulatory briefing documents. Mentor and provide scientific guidance to junior scientists and research associates.

Requirements

Knowledge Requirements (Background/Skills/Experience):

• Education: Ph.D. in Cell Biology, Bioengineering, Molecular Biology, Biochemistry, Pharmacology, or a related discipline with 4+ years of relevant post-degree industry experience (or M.S. with 8+ years of industry experience) in assay development and analytical characterization.
• Potency & Bioassay Expertise: Demonstrated track record of designing, developing, optimizing, and qualifying quantitative cell-based potency assays (e.g., reporter assays, target knockdown/knock-in readouts, functional efficacy assays, dose-response/parallelism models).
• Analytical Methodologies: Hands-on expertise accross diverse analytical platforms, including flow cytometry, high-content imaging, digital PCR (ddPCR and qPCR), ELISA/MSD, and Western/capillary electrophoresis.
• Potency Assays: Experience with biostatistics, parallelism and relative potency analyses including the use of statistical software packages for bioassay analysis (e.g., PLA, JMP, SoftMax Pro).
• Tech Transfer & Vendor Management: Proven experience transferring analytical methods to external CROs/CDMOs, reviewing validation protocols and reports, and resolving assay performance discrepancies.
• Regulatory & Quality Standards: Thorough understanding of phase-appropriate assay validation frameworks, bioassay statistical analysis, and relevant regulatory guidance.
• Communication & Execution: Exceptional analytical problem-solving abilities, project management discipline, and the communication skills required to represent the potency charter across interdisciplinary teams and executive forums.
• Experience authoring analytical development and potency sections for regulatory submissions (IND, CTA, or briefing books).
• Experience using collaboration tools – SharePoint and Microsoft 365 applications.
• Digital fluency in ELNs, AI-assisted research tools, and automation platforms.