Overview:

The Scientist /Senior Scientist position is open to highly motivated and innovative candidates with a Ph.D. degree, a successful post-doctoral fellowship and 3+ years of experience working in the biotechnology or pharmaceutical industry setting. This person will be part of the Biomarker and Bioanalysis group and be responsible for developing and validating immunology assays.

Our client is a clinical-stage, biotech company focused on the development of novel cell-based cancer therapies. Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.

Responsibilities: 

• The main responsibilities will include but are not limited to:
• Design and perform relevant biomarker and immunological assays including multiparameter flow cytometry and cytokine analysis to support clinical trials.
• Contribute to addressing key translational research questions in pre-clinical and clinical safety and efficacy studies such as understanding mechanism of action (MOA) of drug candidates.
• Contribute to biomarker plan/strategies for clinical trials and execution of planned assays.
• Develop in-vitro and ex-vivo assays to translate pre-clinical data into clinical biomarkers for advancing drug candidates through clinical trials.
• Collaborate with discovery, preclinical development, process development, regulatory and clinical teams to accelerate product pipelines.
• Work with external partners and CROs in implementing developed and qualified assays.
• Contribute to IND applications, clinical protocols and other regulatory documents.
• Responsible for planning, designing, executing, recording and analyzing experiments
• Write and review SOPs, technical protocols and reports.
• May supervise research associates.
  

Preferred Qualifications: 

• PhD in Immunology or related field with a background in human immunology, cellular therapy, immuno-oncology and/or tumor biology in hematological and solid malignancies. Experience and knowledge of CAR T therapies is preferred.
• Demonstrated experience working with clinical samples, assay development and validation of analytical methods per ICH Q2 guidelines.
• Experience with development and implementation of relevant biomarker and immunological assays. Significant experience in multi-parameter flow cytometry a must. Experience in one or more of the following: MSD/ELISAs, T cell-based assays, IHC and gene expression analysis.
• Experience working in a GCLP regulated environment.