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8-9年经验 -
本科 -
招1人 -
11-09 发布
职位描述
职位描述： ESSENTIAL DUTIES AND RESPONSIBILITIES:1、Applies scientific principles to design and conduct manufacturing processes，supports CMO activities.2、Follows organizational health and safety guidelines.，works in GMP cleanroom and BSL-II facilities.3、Operates and oversees operation of mechanical equipment including filling systems/lyophilization and other formulation activities “on the floor” in GMP suite. Troubleshoots, cleans and maintains process equipment.4、Skilled in design and operation of a variety of all activities of fill and finish in the GMP environment; participates in technology transfer of DP production.5、Serves as technical lead for formulation projects in-house. Solves complex technical challenges. Assists in scale up and execution of GMP drug production manufacturing procedures. Develop stable and bioavailable formulations for clinical use.6、Perform basic statistical analysis of experimental data; Generate data for project progression and regulatory filings, conduct optimization and process scale up studies.7、Manages all aspects of formulation operations including preparation, DP production, batch record and SOP generation；maintains a clean, well-organized GMP suite.8、Leads resolution of Deviations, CAPAs, ICARs, and lead other continuous improvement initiatives specific to DSP operations.9、Participates in FAT, SAT, Validation, and Startup of DP manufacturing areas.10、Completes proper documentation of all work in applicable approved formats.11、Develops and maintains metrics databases to identify important trends in manufacturing operations.12、Applies Performance Management to develop, evaluate, mentor employees and ensure proper training and development.13、Perform other related job duties as required by supervisor. Works flexible hours to accommodate production schedules.SUPERVISORY RESPONSIBILITIES:1、Supervises Downstream staff as required.QUALIFICATIONS AND REQUIREMENTS:1、Bachelor’s Degree required, Master’s Degree preferred.2、Seven (7) or more years’ experience in with GMP drug product manufacturing, release testing, formulation development, and characterization. A supervisory role in cGMP drug production manufacturing or process development operations.3、Supervisory experience required including assessing daily shift needs, scheduling work activities and deploying properly trained staff to meet production schedules.4、Experience with a range of dosage forms, including injectable product.5、Must be well-organized and self-motivated, and possess an independent work style.6、Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and contract organizations.7、Must have excellent communication, analytical, and organizational skills. Good English reading and writing skills plus. 职能类别： 生物工程/生物制药 医药技术研发人员 关键字： 制药 生产
联系方式
桑田街218号生物产业园8栋
公司信息
ZAI Lab is a leading biotech company based in China focused on discovering and developing innovative medicines for unmet medical needs globally. The company is building a strong portfolio of therapeutic programs aimed at transforming patients’ lives. Zai Lab has a world class leadership team with deep experience at global pharmaceutical and biotech organizations. The team has a strong track record of success – successfully taken five novel drug candidates into clinical trials in China, pioneered new regulatory channels, secured regulatory approvals in record times, conducted multiple IND trials in the US, and brought the first China discovered drug into Global Phase III trials. Zai Lab is committed to build a globally leading drug research and development powerhouse with a culture of excellence and teamwork and a strong focus on fostering innovation and creativity. For more information, please visit www.zailaboratory.com.
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