Scientist, Analytical Science & Method Transfer

ppWe 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. /p h3Key Responsibilities /h3 ul liLead and coordinate analytical method transfer activities to or between Quality Control laboratories and external contract manufacturers /li liAct as SME (Subject Matter Expert) for analytical issues during technology transfer and commercial manufacturing of drug substances and drug products /li liPerform scientific troubleshooting for analytical methods (e.g., HPLC, GC, spectroscopy) in response to OOS, OOT, and atypical results /li liSupport CMOs/CDMOs in establishing analytical methods, resolving analytical challenges, ensuring alignment with internal standards and regulatory dossiers /li liIn case of method transfer by revalidation: design, optimize, and validate analytical methods according to ICH guidelines and GMP requirements /li liReview and approve method transfer protocols, validation reports, and analytical documentation /liliDrive root cause analysis and define CAPAs for analytical deviations in collaboration with cross-functional teams /li liEnsure consistent method lifecycle management, including continuous improvement and robustness enhancement /li liSupport regulatory submissions by preparing and reviewing analytical sections (e.g., CTD Module 3) for new laboratories and CMOs /li liAct as a key interface for Analytical Science Method Transfer between Technology transfer team, Quality Assurance, Regulatory Affairs, and external partners /li /ul h3Core Expertise /h3 ul liAnalytical method transfer strategies (internal labs and CMOs) /li liAnalytical method development, validation, and lifecycle management /li liAdvanced analytical techniques: /li ul liHPLC / UPLC /li liGC /li liDissolution /li liSpectroscopy /li /ul liTroubleshooting deviation management (OOS/OOT investigations) /li liData evaluation /li liGMP, ICH guidelines, and regulatory compliance /li /ul h3Professional Skills /h3 ul liExperience working with contract manufacturers (CMOs/CDMOs) in a global environment /li liStrong scientific problem-solving and troubleshooting mindset /li liExcellent communication skills for interfacing with internal teams and external partners /li liStructured and results-driven project management capabilities /li liHigh level of accountability, persistence, and attention to detail /li liAbility to manage multiple priorities in a regulated environment /li /ul h3Qualifications /h3 ul liDegree in Chemistry, Pharmaceutical Sciences, or related field (e.g., HTL, ETH, MSc or equivalent) /li liMinimum 5 years of experience in analytical development or quality control within the pharmaceutical industry /li liProven track record in method transfer and analytical troubleshooting /li liSolid knowledge of GMP, ICH, and ISO standards /li /ul /p #J-18808-Ljbffr