Sr. Scientist Biologics AD

<p style="text-align:left !important">At Johnson &amp; 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 <a target="_blank" href="https://www.jnj.com."><span style="color:#0000ff"><u>jnj.com</u></span></a>.</p><p></p><p>As guided by Our Credo, Johnson &amp; Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.</p><p></p><p></p><p style="text-align:left"><b><span><span>Job Function: </span></span></b></p>Discovery &amp; Pre-Clinical/Clinical Development<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span><span>Job Sub </span></span><span><span>Function: </span></span></b></p>Biotherapeutics R&amp;D<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Category:</b></p>Scientific/Technology<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>All Job Posting Locations:</b></p>Schaffhausen, Switzerland<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Description:</b></p><p>The Particulates and Container Closure Integrity (PCCI) team is a development lab within the global Janssen Research &amp; Development organization embedded in the GMP environment of the Johnson&amp;Johnson Innovative Medicine Supply Chain (IMSC). As part of analytical development, we provide end-to-end support working closely with our R&amp;D partners and IMSC in an international, dynamic, and dedicated team responsible for biotherapeutic products across numerous therapeutic areas such as oncology, immunology, and neuroscience.</p><p>To strengthen our team, we are seeking a dedicated senior scientist to represent the team and coordinate early and late phase and commercial programs. In this position, you are responsible for further developing the center of excellence (CoE) for container closure integrity testing (CCIT) for products in the cell and gene therapy, antibody and antibody drug conjugate space, building up, growing, and coordinating laboratory analytics for CCI testing. Your scientific dedication and agility to work in a GMP-regulated development environment are essential to ensure robust and compliant applications and approaches. After a thorough on-the-job training, you will have responsibility for project coordination, method validations and transfers to manufacturing sites and commercial quality control laboratories, drafting regulatory submissions and supporting marketed products.</p><p></p><p><b>Your Responsibilities:</b></p><ul><li><p>Assume a leading role in project coordination and validation of CCIT assays for cell and gene therapy, antibody and antibody drug conjugate programs representing the PCCI team and supporting our partner organizations.</p></li><li><p>Build on existing biosafety know-how and infrastructure to expand CCIT analytical portfolio for cell and gene therapy products</p></li><li><p>Coordinate activities pertaining to PCCI CCIT method development, validations and transfers in compliance with internal guidance&#39;s and health authority expectations</p></li><li><p>Coordinate all project-related tasks with our partners</p></li><li><p>Represent the PCCI team in project meetings as CCIT subject matter expert</p></li><li><p>Writing scientifically sound technical documents e.g., study/validation protocols and reports</p></li><li><p>Compiling data for registration dossier</p></li><li><p>End-to-end understanding of business processes and ability to propose changes to strive for high efficiency</p></li><li><p>Highly motivated to work on novel technologies and scouting for new technologies</p></li><li><p>Work in a team-oriented environment and respect diversity and inclusion when interacting with partners and colleagues</p></li></ul><p></p><p><b>Qualifications</b></p><p>For this position we are looking for a scientifically minded, flexible and team-oriented person with the following skills:</p><ul><li><p>Self-employed and entrepreneurial style</p></li><li><p>Curiosity and drive to deep-dive into scientific questions</p></li><li><p>Excellence in analytics, project coordination and presentation skills</p></li><li><p>Background in CCIT and cell and gene therapy, antibody and antibody drug conjugate analytics advantageous</p></li><li><p>Experience within the pharmaceutical or GMP-regulated industry preferred and knowledge of relevant GMP regulations for analytical laboratories</p></li><li><p>Excellent communication skills in English (written and spoken), German desired</p></li><li><p>Minimum requirement: M.S. with at least 5 years’ experience or PhD with at least 2 years’ experience in life science, material sciences, analytical development or pharmaceutical development</p></li></ul><p>We are offering you a multifaceted opportunity in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure!</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p> </p><p> </p><p><b>Required Skills: </b></p><p> </p><p> </p><p><b>Preferred Skills:</b></p>Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Consulting, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Pharmacogenetics, Pharmacovigilance, Process Improvements, Quality Assurance (QA), Relationship Building, Research Documents, Scientific Research, Technologically Savvy