Sr. Scientist, Molecular Biomarker Assays

Piper Companies is currently seeking a Sr. Scientist, Molecular Biomarker Assays to work within the Translational Development team for a cell therapy developer in Philadelphia, PA.

 Responsibilities:

• The role is expected to be 50-75% lab based.
• Develop & deploy qPCR/ddPCR-based molecular assays for PK monitoring in the clinic
• Select appropriate platforms/ assays & implement MRD testing in clinical trials in heme malignancies. Includes exploratory approaches such as liquid biopsies.
• Define & lead appropriate NGS-based exploratory analyses of clinical specimen for elucidating MOA/ mechanisms of resistance. Includes investigating mechanisms of antigen loss/ tumor heterogeneity and iNK/iT profiling.
• Hands-on development & qualification of novel qPCR/ ddPCR based assays for analysis of blood/ tissue biomarkers
• Define assays for outsourcing and direct appropriate GxP or ‘fit-for-purpose’ validation at CRO partners
• CRO management for transfer/ validation of clinical biomarker assays & generation of high-quality data
• Perform selected biomarker assays on clinical trial samples in-house, analyze, interpret and communicate data to management
• Establish best practices and SOPs for in-house clinical sample processing & testing, data storage, analysis and reporting
• Evaluate best methods to collect clinical samples for various downstream biomarker assays
• May participate in the evaluation/suitability of novel cutting-edge technologies appropriate for translational studies
• Collaborate with research, analytical development, QC, compliance and computational biology teams as appropriate, to achieve the above objectives

Qualifications:

• PhD (or MD, DVM) in biological field with 4-6 years of post-doc/industry experience, or MS 10+ years relevant professional experience.Degree/ experience in molecular biology/immunology or related field.
• Biomarker assay validation experience in an industry setting (or similar experience in an academic environment)
• Strong experience in molecular methods including qPCR, ddPCR, applications in next-gen sequencing (with understanding of data analysis pipelines)
• Experience in immune oncology
• Experience with human T cell and/or NK cells isolation and profiling
• Management of assay development work at CROs/external partners
• Working knowledge of GxPs
• Self-starter with the ability to wok in a dynamic startup environment

Preferred:

• Prior cell therapy experience

• Expertise in multicolor flow cytometry
• Experience with single cell profiling NGS assays (10x is a plus)
• Experience with high-plex molecular analysis platforms used in translational research such as nanostring, MSD, immune-PCR etc.
• Strong verbal and written communication skills with experience presenting data to a diverse cross-functional audience

 Compensation:

·       Commensurate on experience 

·       Full-time, permanent

·       Comprehensive Medical benefits: Medical, Dental, Vision, 401K