Sr. Scientist Proteins AD

pAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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. /ppAs 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 Development Job Sub Function: Biotherapeutics RD Job Category: Scientific/Technology All Job Posting Locations: Schaffhausen, Switzerland /ppJob Description: Job Description: The Container Closure Integrity (CCI) team is a development laboratory within the global Research Development organization and operates in the GMP environment of Johnson Johnson Innovative Medicine Supply Chain (IMSC). As part of Analytical Development, we provide end-to-end support for biologics and advanced therapy products, including antibodies, cell and gene therapies, and antibody-drug conjugates, across therapeutic areas including oncology, immunology, and neuroscience. We work closely with RD and IMSC partners in an international, dynamic, and collaborative environment. To strengthen our team, we are seeking a Senior Scientist to lead projects for early- and late-phase development programs and commercial products. You will help advance our center of excellence (CoE) for container closure integrity testing (CCIT) of primary containers, sterile barrier integrity testing (SBIT) of devices and residual seal force testing (RSF), expand laboratory capabilities, and deliver robust, compliant analytical strategies and analytical procedures in a GMP-regulated development environment. Following comprehensive on-the-job training, you will coordinate projects, lead method development, validation, and transfer activities, support investigations, contribute to regulatory submissions, and provide analytical support for marketed products. /ph3Your Responsibilities: /h3ulliAssume a leading role in project coordination, development and validation of CCIT, SBIT and related assays for a variety of container closure systems (CCS) and devices for cell and gene therapy, antibody, and antibody-drug conjugate programs, representing the CCI team across JJ Innovative Medicine. /liliCoordinate method development, validation, and transfer activities in accordance with internal guidance and health authority expectations. /liliProvide timely scientific support for investigations and other high-priority stakeholder requests with short turnaround times. /liliAlign project plans, deliverables, timelines, and risks with internal and external partners. /liliRepresent the CCI team in project meetings as a subject matter expert. /liliAuthor scientifically sound technical documents, including study and validation protocols, reports. /liliCompile, interpret, and communicate analytical data to support project decisions, investigations, and regulatory deliverables. /liliDevelop an end-to-end understanding of business processes and propose improvements that increase quality and efficiency. /liliEvaluate emerging technologies and translate promising approaches into fit-for-purpose laboratory capabilities. /liliContribute to an inclusive, team-oriented environment and collaborate respectfully with partners and colleagues. /li /ulh3Qualifications: /h3ulliIndependent, accountable, and entrepreneurial working style. /liliScientific curiosity and the ability to investigate complex questions in depth. /liliStrong analytical reasoning, project coordination, communication, and presentation skills. /liliExperience with container closure systems, such as vials, prefilled syringes or cartridges, bags, or devices such as needle-based injection systems and on-body delivery systems are advantageous. /liliExperience in the pharmaceutical industry or another GMP-regulated environment, with knowledge of GMP requirements for analytical laboratories, is preferred. /liliExcellent written and spoken English; German language skills are desirable. /liliMaster’s degree with at least five years of relevant experience, or PhD with at least two years of relevant experience, in life sciences, materials science, analytical development, pharmaceutical development, or a related field. /li /ulpWe offer a varied and impactful role in a dynamic, international environment, with strong infrastructure and opportunities for professional growth. /ph3Required Skills: /h3ulliAnalytical Development /liliCoaching /liliCritical Thinking /liliGMP Compliance /liliProject Coordination /liliRegulatory Documentation /liliScientific Writing /liliHead Space Analysis /liliHelium Leak Detection /liliCCIT at Frozen conditions /liliResidual Seal Force Testing /liliStakeholder Communication /liliCMC /liliInvestigation /liliEmerging Technologies /liliProcess Improvement /liliQuality Assurance /liliRelationship Building /liliTechnologically Savvy /li /ulh3Preferred Skills: /h3ulliAnalytical Development /liliCoaching /liliCritical Thinking /liliGMP Compliance /liliProject Coordination /liliRegulatory Documentation /liliScientific Writing /liliHead Space Analysis /liliHelium Leak Detection /liliCCIT at Frozen conditions /liliResidual Seal Force Testing /liliStakeholder Communication /liliCMC /liliInvestigation /liliEmerging Technologies /liliProcess Improvement /liliQuality Assurance /liliRelationship Building /liliTechnologically Savvy /li /ulpJob Function: Discovery Pre-Clinical/Clinical Development Job Sub Function: DPDS, TDS Proteins AD Job Category: Scientific/Technology Primary Job Posting Location: Schaffhausen, Switzerland Additional Job Posting Locations: Legal Entity Name: 8562-Cilag AG Legal Entity Pay Grade: 26 /ph3Required Skills: /h3ulliAnalytical Reasoning /liliBiochemistry /liliChemistry /liliManufacturing /liliand Control (CMC) /liliCoaching /liliConsulting /liliCritical Thinking /liliDrug Discovery Development /liliEmerging Technologies /liliMolecular Diagnostics /liliPharmacogenetics /liliPharmacovigilance /liliProcess Improvements /liliQuality Assurance (QA) /liliRelationship Building /liliResearch Documents /liliScientific Research /liliTechnologically Savvy /li /ulh3Preferred Skills: /h3ulliAnalytical Reasoning /liliBiochemistry /liliChemistry /liliManufacturing /liliand Control (CMC) /liliCoaching /liliConsulting /liliCritical Thinking /liliDrug Discovery Development /liliEmerging Technologies /liliMolecular Diagnostics /liliPharmacogenetics /liliPharmacovigilance /liliProcess Improvements /liliQuality Assurance (QA) /liliRelationship Building /liliResearch Documents /liliScientific Research /liliTechnologically Savvy /li /ulpAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 /ppDo Not Sell or Share My Personal Information Limit the Use of My Personal Information /p #J-18808-Ljbffr