Sr/Pr Scientist, Tumor Profiling & Diagnostics
Piper Companies is seeking a Scientist, Tumor Profiling & Diagnostics to work within the Translational Development team for a cell therapy developer in Philadelphia, PA.
- Lead and recommend appropriate strategies (including technologies, platforms and biomarkers) for answering specific biological questions associated with pharmacodynamics and mechanism of action of company products
- Spearhead the development and validation of tissue-based biomarker assays using singleplex or multiplex IHC, IF and ISH protocols on automated slide-based tissue platforms to better understand the immune and tumor microenvironment
- Implement efficient imaging workflows for digital whole slide imaging and spectral scanning of histologic slides
- Partner with external pathologists and digital pathology CROs as needed to develop and use quantitative image analysis methods for the evaluation of clinical samples
- Oversee and manage outsourcing of high complexity histology-based biomarker assays and CAP-CLIA IHC assay development and validation, according to the project timelines
- Establish optimal protocols for clinical sample handling; develop relevant SOPs for specimen collection and performance of in-house assays on tissue samples
- Monitor the performance of the biomarker assays during clinical study conduct, organize and analyze results, and communicate to management and stakeholders
- Establish proactive and collaborative partnerships with company research, regulatory, clinical and the extended translational team to define scope, resources and timelines for assay readiness
PhD (or MD, DVM) in Pathology, Immunology, cellular/ molecular biology or related field with 5-10 years of post-PhD experience, preferably in an industry/histo-pathology CRO or academic setting, working with clinical specimens.
- Extensive hands-on experience in histopathological techniques, including tissue sample preparation, special stains, IHC, and multiplexed IF staining, and use of automated staining (e.g. Leica Bond) and scanning platforms
- Strong assay protocol development, optimization, and trouble-shooting skills in pathology experiments (i.e., IHC/ISH/IF/Multiplexing).
- Experience in image processing and analysis using existing software packages (such as Halo, Definiens, ImageJ)
- Understanding of regulatory guidance and the phase-appropriate assay validation requirements for companion diagnostic development
- Experience in cell therapies/ Immune oncology biomarkers and early phase clinical trials
- CAP-CLIA IHC assay development/ validation experience
- Management of personnel and vendors
- Experience with exploratory multiplexed technologies such as Ultivue, RNAscope, Akoya Opal, Spatial imaging such as Nanosting DSP etc.