Scientist II, Histologist

Role Summary

Scientist II, Histologist responsible for applying histology, molecular pathology, and translational techniques to support gene therapy research and development programs. Focus on tissue-based analyses to inform clinical programs and biomarker discovery.

Responsibilities

• Receive, accession, and verify tissue specimens from preclinical and/or clinical studies.
• Perform tissue fixation, processing, embedding, and sectioning (paraffin and frozen samples).
• Prepare high-quality tissue sections using microtomy and cryosectioning for downstream analysis.
• Perform immunohistochemistry (IHC) and immunofluorescence (manual and automated) to detect therapeutic gene products, disease biomarkers, and cellular responses.
• Conduct in situ hybridization (ISH) techniques (e.g., FISH, RNAscope) to detect and localize specific DNA/RNA sequences in gene therapy studies.
• Apply routine and advanced histochemical stains (e.g., H&E) for morphological and pathology assessments.
• Examine slides under a microscope to evaluate tissue integrity, therapeutic gene expression, and any treatment-related changes.
• Capture and analyze images using digital pathology and imaging software; quantify biomarker expression patterns and distribution.
• Maintain meticulous documentation of all procedures, results, and quality control measures in compliance with GDP/GLP standards.
• Contribute to the preparation of study reports, regulatory filings, and scientific publications.
• Develop and validate novel histology and molecular pathology protocols tailored for gene therapy applications.
• Partner with Translational Science and Computational Biology teams to integrate tissue-based findings with multi-omics and biomarker datasets.
• Identify and implement emerging technologies to advance translational capabilities.
• Work cross-functionally with Clinical Development, Translational Science, and Research to ensure histological findings align with program goals.
• Manage relationships with external CROs, collaborators, and academic labs for histology services and method transfers.

Qualifications

• Education: Bachelor’s degree in Histology, Biology, Medical Laboratory Science, or related field required; advanced degree (M.S.) preferred.
• Certification: HT(ASCP) or HTL(ASCP) certification strongly preferred.
• Experience: 3–6+ years of histology experience in a research or clinical setting, ideally within biotechnology, pharmaceutical, or translational science environments.
• Demonstrated expertise in IHC, ISH, and advanced histology methods applied to gene therapy or molecular pathology.
• Familiarity with preclinical animal models, human tissue handling, and tissue-based biomarker discovery.
• Strong proficiency with imaging platforms and quantitative pathology software.
• Excellent communication, organizational, and teamwork skills.
• Ability to operate in a fast-paced, high-growth environment with strict adherence to quality and compliance standards.

Skills

• Histology techniques (paraffin and frozen sections)
• Immunohistochemistry and immunofluorescence
• In situ hybridization (FISH, RNAscope)
• Histochemical staining (H&E)
• Digital pathology and image analysis
• Biomarker discovery and data integration
• Documentation and GMP/GLP compliance

Education

• Bachelor’s degree in Histology, Biology, Medical Laboratory Science, or related field required; M.S. preferred.