職位描述

Responsibilities a)Lead CMC activities of protein based drug development and manufacturing. Provide leadership to all aspects of CMC Team activity. b)Select and manage the CRO company, communicate with the CRO team in time, and smoothly advance the project to the IND. c) Establish, manage and lead the CMC development plan for drug substances and drug products from pre-clinical through clinical stage. d)Working with Quality Assurance, develop SOPs and guidelines related to the production, planning, disposition and management, materials, etc. Work with Regulatory, QA and Senior Management to ensure that all company policies are adhered to and all external manufacturing activities comply with relevant regulations e)Prepare CMC regulatory filing sections (domestic and international) working with Regulatory and Quality f)Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations, as required g)Develop production plans to support preclinical, clinical and adjust plans as appropriate to meet corporate objectives h)Provide comprehensive project analysis to senior management as required in the form of reports or presentations as needed Qualifications a)MS or Ph.D. degree in life science preferring cell biology or chemistry, MS with 10 years or Ph.D. with 8 years of work experience in CMC project management, development, scale-up and clinical development and manufacturing in the biotech or pharmaceutical industry b)Proven track record in achieving regulatory approval of new drugs or biologics c)Experience in two or more functional areas in cell line development, cell culture, purification, analytical, formulation, QC, QA, project management in the biologics industry. d)Good understanding of ChP, ICH, GxP guidelines and NMPA/ FDA regulations relating to CMC-related areas. e)Experience with staff management and/or CMC team ma