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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. Learn more at https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Nonclinical Safety

Job Category:

Scientific/Technology

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

About Innovative Medicine:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Senior Scientist, Medical Lab Scientist to be located in Spring House, PA.

Purpose:

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.

The Senior Scientist will be responsible for the day-day conduct in all aspects of Clinical Pathology Laboratory work (Hematology, Coagulation, Immunoassay, Clinical Chemistry, Urinalysis), working with multiple species’ samples to support the pipeline portfolio and explore novel and innovative approaches to safety assessment in drug development. The candidate will possess strong technical and scientific expertise in automated and manual laboratory techniques, is confident in tackling new challenges, shows initiative, and will thrive in a dynamic, multidisciplinary and collaborative environment. This role reports to the Translational Biomarker lead of the CPSB team.

You will be responsible for:

• Providing technical & scientific expertise in the CPSB laboratory as an individual contributor in medical technology and clinical laboratory operation, working with relative independence, to drive the science through technical and scientific collaborative engagement with PSTS and customers across J&J

• 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 communicate 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

Qualifications / Requirements:

Education:

• 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 Master’s degree is preferred

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

Preferred:

• 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

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ra-employeehealthsup@its.jnj.com ) or contact AskGS to be directed to your accommodation resource.