Senior Scientist, Medical Lab Scientist

About the position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. We are searching for the best talent for a Senior Scientist, Medical Lab Scientist to be located in Spring House, PA. The Clinical Pathology & Safety Biomarkers (CPSB), Pathobiology, Preclinical Sciences and Translational Safety (PSTS), is seeking a highly motivated Senior Scientist/Medical Laboratory Scientist responsible for conduct of high-quality clinical pathology service in the CPSB laboratory. The CPSB laboratory is a team of medical laboratory and biomarker scientists responsible for delivering on the PSTS translational safety biomarker vision of end-to-end (efficacy-to-safety, Discovery through Post-Marketing) across all J&J modalities and therapeutic areas.

Responsibilities

• Providing technical & scientific expertise in the CPSB laboratory as an individual contributor in medical technology and clinical laboratory operation.
• Performing Hematology, Platelet function, Coagulation, Immunoassay, Clinical Chemistry, Urinalysis, and Blood Gas analyses to generate high quality data.
• Implementing innovative clinical pathology-based approaches and techniques to solve issues of toxicological concern and mechanistic basis for human risk assessment.
• Ensuring proper equipment maintenance, quality assurance, quality controls, data and data preparation for archiving.
• Verifying, validating, conducting and troubleshooting robust, fit-for-purpose clinical pathology assays in multiple species including human samples with minimal direction.
• Cross-training and contributing to other laboratory sections as needed that could include flow cytometry, immunoassays, molecular and cell-based in vitro assays.
• Adhering to the principles of Good Laboratory/Clinical Practices (GLP/GCP), including compliant use of an electronic notebook system.
• Interpreting and communicating data with an appropriate level of independence.
• Reviewing data of colleagues with detailed rigor for data integrity compliance.
• Adhering to company policies (i.e., Environmental Health and Safety) that ensure a safe laboratory workplace.
• Collaborating and liaising with other J&J groups, external partners, and Contract Research Organizations (CROs) to manage the validation, and execution of clinical pathology assays.

Requirements

• A minimum of a Bachelor's Degree with a Medical Laboratory Scientist (MLS) certification by the American Society for Clinical Pathology (ASCP) is required.
• A minimum of 10 years work experience in the field of Clinical Pathology and Laboratory Medicine is required.
• Advanced proficiency in instruments and applications in Hematology, Coagulation, Platelet function, Immunoassay, Clinical Chemistry, Urinalysis, Blood Gas is required.
• Proficiency with Microsoft Excel and PowerPoint is required.
• Excellent oral and written communication skills are required.
• Strong skills related to time management, attention to detail and documentation are required.
• A passion for teamwork and being comfortable working in a highly interactive, inter-disciplinary and vibrant environment are required.
• Work with minimal supervisory oversight in experimental planning, design, execution, optimization, data analysis and interpretation is required.
• The ability to balance moving projects forward in the face of continuously evolving priorities and timelines while creating an environment of scientific curiosity promoting the exchange of ideas is required.

Nice-to-haves

• Experience working for a pharmaceutical company, reference laboratory, or Contract Research Organization (CRO) is preferred.
• Experience with at least one of GLP, Clinical Laboratory Standards Institute, and/or Clinical Laboratory Improvement Amendments validation standards is preferred.
• Proficiency with multiple platelet function assays (e.g. light transmission aggregometry, whole blood aggregometry, PFA-100, platelet serotonin release assays) is preferred.
• Proficiency with one or more of immunoassays (e.g., ELISA, electrochemiluminescence, multiplex platforms), molecular assays (e.g. PCR), thromboelastography, and flow cytometry is preferred.