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.

Responsibilities:

• 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

Qualifications: 

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

Preferred Skills:

• 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.