Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Scientist, located in Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/
for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Scientist will provide supervision of the basic day-to-day lab operation, deliver and meet the agreed metrics and timeliness for completion and reporting Clinical Pathology data from toleration studies and studies from Discovery Projects, TAs, Cross-Sector projects, Investigative & Mechanistic Toxicology and Janssen supported Consortia Safety Biomarker Initiatives. In addition, they will provide insights and identify the scientific and technical resource needed to develop novel translational safety biomarker assays e.g., coagulation assays, that may be required for both discovery and development projects within the space from Lead Optimization to initiation of Phase 1 Clinical studies. The Scientist will work collaboratively globally within the Clinical Pathology group to strengthen the scientific and technical expertise in the area of Immunoassay specifically using the Multi-Plex Luminex® Technology and Flow Cytometry. Additional responsibilities include but are not limited to:
- Drive scientific and technical support to develop Safety Biomarker Assays to resolve issues of target organ related toxicity
- Contribute to the identification of new “safety” biomarkers and assist in the design and execution of appropriate qualification and validation studies ensuring rigorous and robust criteria to meet appropriate standards
- Implement innovative clinical pathology-based approaches and techniques to solve issues of toxicological concern and mechanistic basis for human risk assessment, including biomarker design, development and validation
- Collaborate with Pathologists and other scientists in the design, interpretation and communication of study findings and provide the appropriate context of the data and its impact on the discovery program as well as clinical development
- Work collaboratively within Tox-Path to provide staff career development opportunities such as Subject Matter Experts (SME) and Technical Areas Specialists (TAS) within the scientific and technical areas of Global Clinical Pathology
- Develop, implement and manage a lab resource framework balancing “in and out sourcing”, fit-for-purpose and context of use assay development
- Develop collaborative partnerships to exploit the use and application of innovative platforms and technologies aimed at improving pre-clinical to clinical translation of Safety Biomarkers.
- BS with at least 7 years experience in the field of Clinical Pathology and Laboratory Medicine OR a MS with at least 5 years experience in the field of Clinical Pathology and Laboratory Medicine or a PhD with at least 3 years experience in the field of Clinical Pathology and Laboratory Medicine is required
- Certification by the American Society for Clinical Pathology (ASCP) is preferred
- Experience in a GLP/GCP laboratory is preferred
- Experience working in Pharmaceutical industry is preferred
- Demonstrated competence in all aspects of Clinical Pathology Laboratory work (Hematology, Clinical Chemistry, Urinalysis, Coagulation etc) is required
- Experience and knowledge in Immunoassay is required
- Experience with Flow Cytometry and Multi-Plex Assays such as Luminex and MSD platforms is preferred
- In depth knowledge of Assay Validation with the knowledge and scientific skills to apply to Methods Development is required
United States-Pennsylvania-Spring HouseOrganization
Janssen Research & Development, LLC. (6084)Job Function