Scientific Senior Manager, Particulates Analytical Development

pAt 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 jnj.com. As guided by Our Credo, Johnson 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 Johnson, we respect the diversity and dignity of our employees and recognize their merit. /ppJob Function: Discovery Pre-Clinical/Clinical DevelopmentbrJob Sub Function: Biotherapeutics RDbrJob Category: People LeaderbrAll Job Posting Locations: Schaffhausen, Switzerland /ppJob Description: We are offering an outstanding opportunity for a Scientific Senior Manager, Particulates Analytical Development (100%). In this position, you will assume a leading role in the Particulates Analytical Development team in Schaffhausen. The team provides end-to-end support for large-molecule projects, including particle analytical procedures for release, characterization and stability testing of drug products, associated devices and combination products. You will apply scientific curiosity and analytical excellence to develop robust, phase-appropriate and compliant approaches in a GMP-regulated environment. A key responsibility will be translating scientific data and analytical strategies into clear technically rigorous content for global regulatory submissions. You will provide scientific and operational leadership for investigation and complaint testing, site and QC laboratory support and lifecycle support while influencing cross-functional decisions and advancing the team’s analytical capabilities. You will also oversee the AD BSL-2 laboratory and associated training activities. /ph3Responsibilities /h3ulliProvide scientific and strategic leadership for particulate matter analytics /liliDefine phase-appropriate analytical strategies for visible and subvisible particulate matter and ensure alignment with product development needs, internal standards, and global health authority expectations /liliLead and oversee method development, qualification, validation, transfer, investigation, and lifecycle activities for particulate matter assays, including planning, execution, documentation, and review /liliServe as SME for particulate analytics in cross-functional teams and provide scientifically sound recommendations for technical issues /liliAuthor and critically review high-quality technical and regulatory documents, including analytical transfer reports, validation documentation, responses to health authority questions, and relevant sections of global regulatory submissions /liliInterpret and integrate complex analytical data into clear scientific conclusions, risk assessments, and regulatory strategies /liliCoordinate project deliverables, timelines, and interfaces with RD, manufacturing sites, commercial quality control laboratories, and other external partners /liliIdentify opportunities to strengthen particulate matter analytics capabilities, improve business processes, and evaluate emerging and innovative technologies to ensure the future-oriented development and sustainability of the analytical portfolio /liliSupport particle-counting analytical procedures for cell and gene therapy products /liliProvide analytical support to QC laboratories, investigations, complaint testing, and site-support activities /liliOversee the AD BSL-2 laboratory, including responsibility for training and compliant laboratory operations /li /ulh3Profile /h3ulliMaster’s degree with at least 10 years of relevant industry experience, or PhD with a minimum of 7 years of relevant experience, in life science, engineering, analytical sciences, pharmaceutical sciences, or a related discipline /liliDemonstrated experience in analytical method development, qualification, validation, or transfer for particle counting methods /liliDemonstrated experience in authoring and reviewing technical content for regulatory submissions is required, including the ability to translate complex analytical data into clear, concise, and scientifically defensible regulatory narratives /liliStrong record of technical writing and scientific presentation /liliExcellent analytical and problem-solving skills, including the ability to identify gaps and root causes and develop practical, innovative solutions /liliAbility to work independently, prioritize effectively, meet tight deadlines, and maintain a constructive attitude /liliDemonstrated ability to lead complex, cross-functional teams, capability and commitment to developing a team-oriented, diverse, inclusive, and Credo-driven culture /liliScientific curiosity, a continuous-improvement mindset, and the determination to challenge the status quo responsibly /li /ulpA pre-identified candidate for consideration has been identified. However, all applications will be considered /ppRequired Skills: Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Developing Others, Drug Discovery Development, Inclusive Leadership, Leadership, Molecular Diagnostics, Pharmacovigilance, Process Improvements, Productivity Planning, Program Management, Quality Assurance (QA), Scientific Research, Tactical Planning, Team Management, Troubleshooting /ppPreferred Skills: Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Developing Others, Drug Discovery Development, Inclusive Leadership, Leadership, Molecular Diagnostics, Pharmacovigilance, Process Improvements, Productivity Planning, Program Management, Quality Assurance (QA), Scientific Research, Tactical Planning, Team Management, Troubleshooting /ppAt 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 /p #J-18808-Ljbffr