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Founded in August 2009, in Nanjing, China SFDA GLP and AAALAC certified DMPK CRO company GLP bioanalytical support for small and macro molecule, toxicokinetics, in vivo PK and ADME study 2
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3 01 Responsible for investigating metabolism pathways and explaining metabolite structures Manage ADME studies and ensure timely delivery of study reports to customer Manage a team of 10-12 scientists Develop methods for qualitative determination and chemical structure elucidation of metabolites from in-vitro and in-vivo studies Contribute to registration documentation and provide input to questions by health authorities Job Description
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4 01 PhD degree in Pharmacokinetics, Drug Metabolism, or related field At least 10 years of industrial experience The ability to demonstrate excellent knowledge in PK and drug metabolism principles is a must Working experience and proficiency with HPLC and LC/MS instrumentation Be familiar with laboratory techniques such as in vitro/in vivo metabolism and PK experiments, analysis of drugs and metabolites in biological fluids Qualifications
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5 02 Direct and manage Pharmacology studies in area of CV, DM and CNS diseases in a regulatory environment Manage a team of scientists to perform high-quality research in compliance with the protocol, company SOPs and AAALAC guidelines Direct communications with sponsors, execute, and complete testing programs that meet sponsor requirements and ensure to deliver on-time high quality reports to clients Job Description
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6 02 PhD or equivalent degree in pharmacology, toxicology, or related fields, have demonstrated experience in the area of CV, DM, or CNS diseases At least 10 years of post-graduate work experience in related fields, be well organized, detail-oriented, and capable handling multiple tasks in a fast-paced growing company environment Highly self-motivated, work in a multidisciplinary team, possess good interpersonal skills and have excellent oral and written communication Qualifications
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7 Job Description 03 As DMPK expert, perform advanced PK and PK/PD analyses and provide result interpretation and guidance As Study Director for GLP and non-GLP studies, provide expertise and guidance for experimental design and facilitate the monitoring, coordination and data collection of PK or PK/PD studies Ensure compliance with relevant regulatory standards (FDA, EMEA and SFDA), as well as external and internal guidelines (e.g. SOP’s)
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8 Qualifications 03 PhD or equivalent degree in Pharmacokinetics, demonstrated experience in regulatory research and possess superior management and problem solving skills ≥7 years of post-graduate work experience in DMPK Strong advanced knowledge of pharmacokinetics and drug metabolism Highly self-motivated, goal orientated, work as part of a team, good interpersonal skills and excellent oral and written communication
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9 04 As DMPK expert, provide programs for experimental design of biological drugs Establish a determination method of macromolecular drugs, including ELISA, RIA, ECLIA, and the FIA Ensure compliance with relevant regulatory standards (FDA, EMEA and SFDA), as well as external and internal guidelines (e.g. SOP’s) Job Description
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10 04 Qualifications PhD or equivalent degree in Pharmacokinetics, demonstrated experience in regulatory research and possess superior management and problem solving skills At least 7 years of post-graduate work experience in biologics Strong advanced knowledge of biologics quantitation method development and validation Highly self-motivated, goal orientated, good interpersonal skills and excellent oral and written communication
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Address: 9 Xinglong Road, Pukou Economic Development Zone, Nanjing, China Email: info@concordpharmatech.cominfo@concordpharmatech.com Website: www.concordpharmatech.comwww.concordpharmatech.com Tel: 011-86 25-58196598 VOIP: 1 908 691-4648
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