Scientist, Analytical Science & Method Transfer

We are currently looking for an experienced analytical science professional specializing in analytical method validation and transfer to contract manufacturing organizations (CMOs/CDMOs). Strong focus on troubleshooting, root-cause investigation, and ensuring robust analytical performance across external laboratories and CMOs under GMP conditions.In this position you will be directly reporting to the CMC Strategy and Technology Transfer Lead.Key ResponsibilitiesLead and coordinate analytical method transfer activities to or between Quality Control laboratories and external contract manufacturersAct as SME (Subject Matter Expert) for analytical issues during technology transfer and commercial manufacturing of drug substances and drug productsPerform scientific troubleshooting for analytical methods (e.g., HPLC, GC, spectroscopy) in response to OOS, OOT, and atypical resultsSupport CMOs/CDMOs in establishing analytical methods, resolving analytical challenges, ensuring alignment with internal standards and regulatory dossiersIn case of method transfer by revalidation: design, optimize, and validate analytical methods according to ICH guidelines and GMP requirementsReview and approve method transfer protocols, validation reports, and analytical documentationDrive root cause analysis and define CAPAs for analytical deviations in collaboration with cross-functional teamsEnsure consistent method lifecycle management, including continuous improvement and robustness enhancementSupport regulatory submissions by preparing and reviewing analytical sections (e.g., CTD Module 3) for new laboratories and CMOsAct as a key interface for Analytical Science & Method Transfer between Technology transfer team, Quality Assurance, Regulatory Affairs, and external partnersCore ExpertiseAnalytical method transfer strategies (internal labs and CMOs)Analytical method development, validation, and lifecycle managementAdvanced analytical techniques: HPLC / UPLC GC Dissolution SpectroscopyTroubleshooting & deviation management (OOS/OOT investigations)Data evaluation GMP, ICH guidelines, and regulatory complianceProfessional SkillsExperience working with contract manufacturers (CMOs/CDMOs) in a global environmentStrong scientific problem-solving and troubleshooting mindsetExcellent communication skills for interfacing with internal teams and external partnersStructured and results-driven project management capabilitiesHigh level of accountability, persistence, and attention to detailAbility to manage multiple priorities in a regulated environmentQualificationsDegree in Chemistry, Pharmaceutical Sciences, or related field (e.g., HTL, ETH, MSc or equivalent)Minimum 5 years of experience in analytical development or quality control within the pharmaceutical industryProven track record in method transfer and analytical troubleshootingSolid knowledge of GMP, ICH, and ISO standardsAbout CSL ViforCSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit Website and CSL Plasma at Website BenefitsFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL.You Belong at CSLAt CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit Website Opportunity EmployerCSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit Website. CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here.CSL Global Privacy Notice for Job Applicants and Candidates #J-18808-Ljbffr