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 athttps://www.jnj.com/innovative-medicine

We are searching for the best talent for a Principal Scientist, Immunoassay, Clinical Pathology & Safety Biomarkers to be in Spring House, PA.

Purpose:

The Clinical Pathology & Safety Biomarkers (CPSB), Pathobiology, Preclinical Sciences and Translational Safety (PSTS), is seeking a highly motivated Principal Scientist to establish the immunoassay capability 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 Principal Scientist will be responsible for the development, validation, oversight, and troubleshooting of fit-for-purpose immunoassays for established and novel safety biomarkers in multiple species including human. The candidate is a subject matter expert in immunoassay analytical validation, is confident in taking on new challenges, 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:

• Serving as a subject matter expert in immunoassays across multiple platforms and technologies (ELISA, MSD, Luminex, digital, immunoPCR, aptamer etc.) capable of leading implementation, defining gaps, and needs, and recommending solutions
• Developing, verifying, validating, conducting and troubleshooting robust, fit-for-purpose immunoassays across multiple species including human samples with minimal supervision
• Implementing innovative clinical pathology and biomarker-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 integrity and data preparation for archiving
• Cross-training and contributing to other laboratory sections as needed that could include molecular and cell-based in vitro assays, flow cytometry, and automated clinical pathology analyzers
• Adhering to the principles of Laboratory/Clinical Practices (GLP/GCP), including compliant use of an electronic notebook system
• Interpreting and communicate data with an appropriate level of quality and independence in report writing and PowerPoint presentations, suitable for multidisciplinary PSTS team meetings team presentations and influencing team decision-making
• Ensuring on-time and within-budget completion of studies.
• Coaching and training junior colleagues in techniques, processes and responsibilities.
• Independently developing standard operating procedure documents to champion high standards of compliance in the laboratory
• Leading meetings with CRO lab(s) for technology transfer or as an internal subject matter expert to discuss validation plans, progress, resources, reagent needs, and issues and communicate timelines and issues to J&J
• 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 liaise with other J&J groups, external partners, and Contract Research Organizations (CROs) to manage the development, validation, and execution of flow cytometric assays

Qualifications / Requirements:

Education:

• A minimum of a Master’s degree in a Biology, Immunology, Biochemistry or a related scientific discipline is required
• A PhD is highly preferred

Required:

• A minimum of 6 years experience developing and validating immunoassays is required
• Mastery of assay development and validation with a consistent track record is required
• Experience in reagent and antibody generation, ligand characterization, and optimization for novel immunoassays is required
• Proficiency with Microsoft Excel and PowerPoint and GraphPad is required
• Experience with at least one of GLP, Clinical Laboratory Standards Institute, and/or Clinical Laboratory Improvement Amendments validation standards are 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 be comfortable working in a highly interactive, inter-disciplinary and vibrant environment are required
• The ability to 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
• Ability to present research at external meetings and participate in external biomarker consortia is required

Preferred:

• Experience working for a pharmaceutical company, in vitro diagnostic manufacturer, reference laboratory, or Contract Research Organization (CRO) is preferred
• Previous experience with assay development and validation for multiple species is preferred
• Proficiency with one or more of the following, molecular assay development and validation (e.g., PCR), flow cytometry, clinical pathology analyzers, and cell-based in vitro assays 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.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.