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Job Description
About Takeda
”Better Health for People, Brighter Future for the World” is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We’re looking for like-minded professionals to join us.
Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company’s founding. Takeda-ism incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.
Objectives / Purpose
Independently leads characterization activities of synthetic-molecule through the strategic planning and execution based on phase appropriate pharmaceutical development.
Supports early-stage developability assessment and candidate selection in collaboration with Research by physicochemical, solid-state characterization, solid form study, and product-relevant understanding.
Contribute to pipeline development and strategic discussion to evaluate impact of decisions across PharmSci functions and other development functions through physicochemical, solid state, structural characterization, solid form study, and technical investigations.
Required to be recognized as a subject matter expert in analytical characterization such as spectroscopic analysis, X-ray analysis, NMR, MS spectrometry, Thermal analysis and other spectrometry for synthetic molecules (Small molecules, Oligonucleotides, Peptides) with the capabilities of data science, in silico modeling for molecular characterization, stability prediction and GI absorption / pharmacokinetic modeling etc.
Accountabilities
· Lead developability assessments for candidate molecules in collaboration with Research and Pharmaceutical Sciences partners.
· Generate and integrate physicochemical, solid-state, stability, and biopharmaceutical evidence to identify development risks and enable candidate selection.
· Translate characterization findings into clear recommendations for candidate selection, developability risk mitigation, solid-form strategy, and formulation direction.
· Apply solid-state and material techniques, such as XRPD, DSC, TGA, DVS, microscopy, spectroscopy, particle characterization, and related methods; expertise in every technique is not required.
· Characterize impurities including nitrosamines and mutagenic impurities and contribute scientific evidence to multidisciplinary risk assessments.
· Lead or support investigations of unexpected analytical observations, material variability, degradation, stability trends, manufacturing events, and product-performance concerns through orthogonal techniques such as NMR, MS, spectroscopy, chromatography, diffraction, thermal analysis, and microscopy.
· Use fit-for-purpose statistics, data visualization, predictive tools, and in silico / AI-enabled approaches to strengthen experimental design, molecular and material understanding, stability assessment, and biopharmaceutical risk evaluation.
· Collaborate closely with Research, DMPK, Drug Safety, Process Chemistry, Formulation Development, and other partners as appropriate.
· Provide scientific oversight of CROs and external laboratories, including study design, protocol / report review, progress monitoring, data evaluation, and resolution of technical issues.
· Prepare and present study plans,…