Principal Lead, MST & Ext Manufacturing

ph3Description /h3 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. /p pAs 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. /p h3Job Function /h3 pDiscovery Pre-Clinical/Clinical Development /p h3Job Sub Function /h3 pBiotherapeutics RD /p h3Job Category /h3 pScientific/Technology /p h3All Job Posting Locations /h3 pSchaffhausen, Switzerland /p h3Job Description /h3 pbPrincipal Lead, MST Ext Manufacturing /b /p 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.br/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.br/bJob Description /b /p pAbout Innovative Medicinebr/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.br/Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. /p h3Key Responsibilities /h3 ul liEnsure timely readiness of contract manufacturing organizations (CMO) or JnJ internal pilot plant to support clinical activities. /li liEnsure timely delivery of clinical material from CMO and/or JnJ internal pilot plant. /li liManage the overall relationship with CMOs and act as the single point of contact between the organization and the respective manufacturing site. /li liProvide input and requirements to drug product development and primary container development teams. /li liSupport scale-up and technology transfer. /li liSource raw materials and components and act as point of contact for material and supplier-related issues at CMO. /li liEnsures that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations. /li liSupport investigations, CAPAs, change controls according to assigned responsibilities and perform critical raw data review for key documents. /li liIdentify opportunities for process optimization and drive continuous improvement initiatives /li liPrepare business plan forecasts and monitor actual spending versus budget. /li /ul h3Qualifications /h3 h3Education /h3 ul liA minimum of a Bachelor's degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biotechnology, or a related field with 8+ years of relevant biopharmaceutical experience, including 8+ years of sterile drug product process development and manufacturing experience; or a Master's degree with 6+ years; or a PhD with 4+ years is required. /li /ul h3Experience and Skills /h3 h3Required /h3 ul liDemonstrated proficiency and experience in biopharmaceutical process design is required. /li liUnderstanding and experience in fill/finish operations is required. /li liExperience in clinical or commercial manufacturing is required. /li liMotivated with the ability to work independently with demonstrated problem solving skills is required. /li liAbility to collaborate with cross-functional teams is required. /li liPrior experience working with a CMO is required. /li liExcellent English and German oral and written language skills are required. /li liGood CMO relationship management skills /li liGood understanding of procurement and legal workflows needed to support contract negotiations and new CMO onboarding /li /ul h3Preferred /h3 ul liProven proficiency and experience in biologics drug product development within the biopharmaceutical industry is preferred. /li liSolid understanding and experience in technology transfer operations is highly preferred. /li liProven track record of creativity and problem solving skills highly preferred. /li /ul h3#DPDS /h3 h3Required Skills /h3 h3Preferred Skills /h3 pAnalytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Coaching, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Organizing, Pharmacovigilance, Presentation Design, Process Improvements, Productivity Planning, Scientific Research /p h3Similar jobs /h3 ul lih3Principal Clinical Research Scientist /h3Discovery Pre-Clinical/Clinical Development Jacksonville / Milpitas / Irvine /li lih3Principal Scientist (Manager), Global Regulatory Affairs, CMC /h3Discovery Pre-Clinical/Clinical Development Beerse / Leiden /li lih3Director Lead Dissolution /h3Discovery Pre-Clinical/Clinical Development Beerse /li /ul h3Careers in Switzerland /h3 pExplore impactful careers with Johnson Johnson in Switzerland. /p h3Careers in Europe, Middle East Africa /h3 pLearn about working at JJ in our locations across Europe, the Middle East and Africa. /p /p #J-18808-Ljbffr