职位描述
Responsibilities:Participate analytical activities to support medicinal chemistry and preclinical development.?Provide analytical and structural characterization data on newly synthesized compounds;?Conduct studies on the physicochemical properties and other pre-formulation assessments of selected compounds;?Provide analytical support on preclinical tox studies.Conduct analytical research & development activities for developing control strategies and methodologies for drug substances and drug products under a GxP environment.?Ensure analytical activities are conducted in compliant with applicable GxP and EHS requirements;?Ensure analytical data and related CMC documents fully meet data integrity requirements;?Participate in analytical R&D activities to deliver all the project related milestones on time as agreed upon with global project teams;?Participate in analytical R&D activities in developing and validating analytical test methods.职位要求:Qualification:?Bachelor or Master’s degree in chemistry or other closely related disciplines with 3+ years (for candidate with a Master degree) and 5+ years (for candidates with a Bachelor degree) relevant work experience in pharmaceutical industry;?Knowledge with ICH guidelines, applicable law and regulations of major markets (China, US, EU, Japan, etc.), and other compendial requirements (USP, EP, ChP etc.);?Good written and communication skills in English and an ability to work effectively with a diverse team of co-workers in a dynamic environment;?Actual level of appointment will commensurate with the candidate’s educational background and work experience.
职能类别:生物工程/生物制药
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