職位描述
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職責描述:
? Working in immunoassay area to provide GLP-compliant service to world-class pharma and biopharma.
? Serve as an internal expert to design, develop and validate assays to measure biological drugs, their targets, or anti-drug antibody (ADA), neutralizing antibody (Nab) in biological fluidic samples from pre-clinical and clinical studies
? Develop and maintain high level of scientific achievements for the BA team. Be expected to be point of contact for technic supporting, and troubleshooting in assays, , including email and video/tele- conference with customers.
? Effectively communicate and interface with business partners, internal Quality Assurance Unit and external regulatory authorities in order to fully comply with GLP and other pertinent regulations.
? Conduct regulatory agency inspections, and serve as a technical liaison to engage and onboard domestic and international clients.
? Prepare, review or approve assay validation and bioanalytical reports and present data to clients
? Provide training and mentorship to internal staffs
Method Development Leader- Small Molecule
Key responsibilities:
? Lead the method development with bioanalytical scientists in LCMS/MS small molecular team to provide GLP-compliant service to world-class pharma and biopharma;
? Serve as an internal expert to design, develop and validate assays and utilize professional knowledge and experience to solve complex technical issues in small molecule clinical bioanalysis;
? Develop and maintain high level of scientific achievements for the BA team. Be expected to be point of contact for technic supporting, and troubleshooting in assays, , including email and video/tele- conference with customers.
? Team working with bioanalytical team including SD/PI, bioanalyst and other related scientific staff. Oversee multiple MD projects/studies conducted at the same time: Manage activities, aggressive timelines, priorities, resources, establish work schedules, and keep meticulous records to ensure on time deliverables. Serves as a center to connect between MD and the project teams;
? Involve in process optimization to improve operation efficiency and quality to reduce the cost and improve customer’s satisfaction.
? Be well versed with WuXi’s program management system in tracking the progress of projects with regard to meet timeline and finance milestones, follow-up actin items for resolutions.
? Effectively communicate and interface with business partners, internal Quality Assurance Unit and external regulatory authorities in order to fully comply with GLP and other pertinent regulations.
? Participate in regulatory audits of projects; Perform duties complied with the related SOPs and according to OECD, USFDA and NMPA (Previous CFDA), etc., GLP guidelines as well as other applicable regulations.
? Provide training and mentorship to internal staffs
任職要求:
Essential:
? PhD degree in Biochemistry, Analytical Chemistry, Pharmacy, or a related field, or a Master’s degree in a related field with extensive clinical work experience (5 years’ work experience).
? A minimum of 2/3 years of industrial experience in CROs and/or pharmaceutical companies
? A minimum of 3/5 years direct experience in large molecules bioanalysis in support of preclinical and/or clinical PK/TK/PD, ADA, and vaccine studies
? Strong understanding of large molecules bioanalysis technologies and GLP/GCP/GCLP
? In-depth understanding of small molecule bioanalytical techniques, including but not limited to HPLC, LC-MS, GC-MS, and their applications in clinical trials.
? Familiar with pharmaceutical R
工作地點
地址:上海浦東新區上海-浦東新區上海藥明康德新藥開發有限公司
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職位發布者
聶女士HR
上海藥明康德新藥開發有限公司
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石油·石化·化工
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1000人以上
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股份制企業
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中國(上海)自由貿易試驗區富特中路288號1號樓

應屆畢業生
博士
2026-03-04 21:17:51
361人關注
注:聯系我時,請說是在江蘇人才網上看到的。
