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某知名制藥公司招聘 CMC lead -可有償介紹合適人選
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Key Responsibilities: ◼ Lead drug substance / drug product development of oligonucleotides, analytical development, Quality Assurance and oversight of manufacturing process with external CDMO and future inhouse GMP manufacturing facility. ◼ Author and review technical protocols and reports in support of preclinical (hundred grams scale) and clinical stage (kilo gram scale) manufacture and process characterization activities. ◼ Contribute to strategic technical discussions and present progress at internal and external scientific meetings. ◼ Lead the preparation of the Drug Product and analytical section of regulatory filings and effectively represent the CMC function in interactions with regulatory authorities. ◼ Effectively integrate CMC activities with other functions, including chemistry synthesis, and Regulatory Affairs, and oversight of manufacturing processes. ◼ Track progress against project timelines, generate regular status updates, and communicate progress and issues to management, including presentation of findings at team meetings. Qualifications: ◼ Ph.D. with 3+ years or master’s with 6+ years degree in chemistry, chemical engineering, biochemical engineering, or pharmaceutical sciences，with prior industry experience in oligonucleotide or peptide products. ◼ Hands-on experience in process development and process validation of drug products and dosage forms across multiple development projects including process transfer and management of contract manufacturing. ◼ Demonstrated management experience of successful drug product process development teams. ◼ Experience in preparing regulatory documents including briefing documents for regulatory meetings. ◼ In-depth understanding and hands-on experience in drug product process development, analytical development and Quality Asssurance. ◼ Hands-on experience in analytical methods for characterization of drug products and processes. ◼ Excellent leadership, organizational and communication skills. ◼ Demonstrated strong operational execution and problem-solving skills. ◼ Eagerness to learn new techniques. |
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