Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Scientist, Clinical /Medical Technologist located in Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
The Scientist, Clinical / Medical Technologist 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, 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. This candidate will work collaboratively globally within the Clinical Pathology group to strengthen the scientific and technical expertise in Immunoassay specifically using the Multi-Plex Luminex® Technology and Flow Cytometry. Demonstrated competence in all aspects of Clinical Pathology Laboratory work (Hematology, Coagulation, ImmunoAssay, Clinical Chemistry, Urinalysis), recognized expertise, experience and knowledge of immunoassay, assess laboratory equipment and instrumentation needs and made appropriate recommendations to Management for purchases to ensure that the technical capabilities and productivity of the laboratory is maximized.
Provide supervisory, technical & scientific leadership to the Clin Path Lab and drive the science through technical and scientific collaborative engagement with Inv & Mech Tox, others groups within PD&S, Therapeutic Area & Drug Discovery Teams
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.
Ensure proper equipment maintenance, preparing data for archiving, electronic protocol data entry, quality control and DDI
Demonstrated competence in all aspects of Clinical Pathology Laboratory work (Hematology, Clinical Chemistry, Urinalysis) with proven track record, experience and knowledge in Immunoassay. Some knowledge and experience with Flow Cytometry and Multi-Plex Assays such as Luminex and MSD platforms is a plus. determining laboratory equipment and instrument needs and made appropriate recommendations for purchases to ensure that the technical capabilities and productivity of the laboratory is maximized forming necropsies processing tissues and preparing histologic slides including special stains
In depth knowledge of Assay Validation with the knowledge and scientific skills to apply to Methods Development; trouble-shooting skills for technically challenging experimental conditions
Ability to organize, prioritize, and schedule with both flexibility and a high standard of performance
The successful candidate must have a least a Bachelor’s Degree, preferably a Master’s Degree, and is certified by the American Society for Clinical Pathology (ASCP). A minimum of 10 years work experience in the field of Clinical Pathology and Laboratory Medicine, work experience in a GLP/GCP laboratory is desirable. Excellent communication skills, computer proficiency, and demonstrated willingness to work collaboratively with scientist from a variety of disciplines is required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Pennsylvania-Spring House-Welsh & McKean Roads
Janssen Research & Development, LLC. (6084)