Senior Scientist, Preclinical, Contractor

Job Locations US-NJ-Warren
ID
2020-1227
Category
Research & Early Development
Type
Contract

Overview

The Senior Scientist position is responsible for providing scientific and technical leadership to enable the development of innovative and life-changing cellular immunotherapies within the R&D group. As a member of the Preclinical team, this scientist will design and manage in vivo studies to support the discovery and development of Immune-Oncology therapeutics and to meet regulatory requirements for pre-IND and IND submissions. In addition, this scientist will be responsible to evaluate in vivo biodistribution of cellular products. The successful individual will demonstrate subject matter expertise in non-clinical toxicology, pharmacology, deep scientific knowledge in immune cell biology and hands-on experience in flow cytometry (FACS), qPCR and immunohistochemistry (IHC). The position will require an individual with strong analytical, leadership and communication skills (both written and oral) and the ability to work with a variety of individual styles.

 

This role will be based in Warren, N.J. until the coporporate move to Florham Park, N.J. 

Responsibilities

  • Design and manage studies in toxicology, pharmacology, pharmacokinetics and pharmacodynamics and other discipline as they relate to preclinical assessment of safety and efficacy
  • Monitor and coordinate outsourced studies to ensure common understanding, compliance with study protocol and regulatory requirements and to achieve high standards of productivity and quality
  • Develop and conduct immunohistochemical assay, imaging analysis and other bioanalytical assays
  • Ensure success of the non-clinical programs through effective interaction with both internal and external collaborators, including scientists, CROs, project managers, regulatory and quality assurance experts, and consultants
  • Participate in the preparation of regulatory submission documents
  • Ensure compliances with GLP regulations in designing protocols, analyzing and interpreting the data and preparing relevant documentation
  • Provide recommendations for, and implement studies and strategies to define the phenotypic and functional characteristics of the cellular product in pertinent in vivo studies
  • Present work at project team meetings, internal forums, and external meetings
  • Author and oversee writing of study reports, patents, and peer-reviewed publications. Presentation of methods, results and conclusions to publishable standards

 

Qualifications

 

  • PhD in a relevant field, Cellular & Molecular Immunology, Cell Biology and Molecular Biology, with post-doctoral/fellowship experience or at least 3 years of relevant work experience are required
  • Strong immunology experience related to T cells, NK cells, and/or antibodies required
  • Experience with CAR T cell development is preferred
  • Experience with in vivo model development in immuno-oncology is preferred
  • Hands-on experience in FACS, qPCR and IHC required.
  • Knowledge of GLP regulations, including writing SOPs and study reports
  • Track record of success as evidenced by a strong publication record, and/or, evidence of sustained contributions in the biopharmaceutical industry
  • Must work effectively in a matrix environment, qualities of scientific leadership are particularly sought
  • Must be a team player, able to collaborate across multidisciplinary terms, and also have the ability to work independently
  • Effective communication is essential and includes presentations to effectively convey scientific concepts and data among research scientists, management teams within internal working groups/project teams, external academic and industrial organizations, review committees, and conferences. Writing for non-clinical protocols, reports, regulatory filings, and scientific publications is also required

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