Description
Apply knowledge of molecular biology, genetics, bioinformatics, and engineering to design, edit, and evaluate genomes and gene expression systems for healthcare, agriculture, and biotechnology, developing gene therapies, engineered organisms, and enabling tools while ensuring safety, efficacy, and regulatory compliance.
- • Design, construct, and optimize genetic constructs, including plasmids, viral vectors, and donor templates.
- • Select and engineer gene editing tools such as CRISPR, base/prime editors, TALENs, or ZFNs.
- • Evaluate the safety, efficiency, and specificity of gene edits and delivery systems.
- • Develop and validate assays (qPCR, NGS, ddPCR, reporter assays) to quantify editing outcomes.
- • Model gene networks and off-target risks using bioinformatics and statistical tools.
- • Perform in vitro and in vivo studies to assess expression, phenotype, and toxicity.
- • Collaborate with clinicians and translational teams to design gene therapy protocols.
- • Develop scalable processes for vector production and edited cell manufacturing.
- • Optimize transfection, transduction, electroporation, and culture conditions.
- • Create and maintain design files, sequence databases, and LIMS records.
- • Write and maintain SOPs, protocols, and biosafety documentation.
- • Train staff on genome editing techniques, aseptic methods, and BSL practices.
- • Coordinate technology transfer to GMP or pilot manufacturing environments.
- • Partner with QA/QC to define specifications, release criteria, and validation plans.
- • Prepare regulatory documents and support IBC, IRB, and FDA submissions.
- • Source and qualify suppliers for plasmids, oligos, enzymes, and vectors.
- • Investigate deviations, troubleshoot experiments, and implement CAPAs.
- • Lead DOE studies to improve yield, fidelity, and process robustness.
- • Design combinatorial libraries and high-throughput screening experiments.
- • Analyze experimental data, maintain traceability, and archive results.
- • Prepare technical reports, publications, and patent filings.
- • Manage project plans, budgets, timelines, and cross-functional deliverables.
- • Review literature to track advances in editing tools, delivery, and safety.
- • Engineer microbes, plants, or cell lines for improved traits or productivity.
- • Develop biocontainment strategies, kill switches, and genetic safeguards.
- • Conduct risk assessments and ensure compliance with biosafety regulations.
- • Collaborate with materials scientists to create novel delivery nanoparticles.
- • Confer with manufacturing to align design with scale-up and purification needs.
- • Recommend process parameters, MOI, and vector specifications based on data.
- • Review and refine workflows to reduce variability, improve yield, and lower cost.
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O*NET occupational data (work activities, skills, knowledge).
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This site includes information from O*NET by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA), used under the CC BY 4.0 license. Career Clutch has modified some of this information for student readability. USDOL/ETA has not approved, endorsed, or tested these modifications. O*NET® is a trademark of USDOL/ETA.
Last reviewed: Jan 2026
