職位描述
崗位職責(zé):
一、活性方法開發(fā)管理Management of bioassay method development
1. 領(lǐng)導(dǎo)/協(xié)助分析團(tuán)隊(duì)開發(fā)理化及功能性試驗(yàn),支持過程和產(chǎn)品放行開發(fā)檢測(cè)
Lead/ assist analytical team to develop physiochemical and functional assays to support process and product development as well as product release.
2. 日常測(cè)試安排支持
Arrange and support routine testing
二、文件規(guī)程管理Document procedure management
1. 撰寫或?qū)徍朔椒ú僮饕?guī)程,方法開發(fā)報(bào)告等
Write or review SOP, method development report etc.
2. 指導(dǎo)和審核分析方法實(shí)驗(yàn)設(shè)計(jì),方法確認(rèn)方案和報(bào)告等
Guide and review analytical experimental design, testing methods and qualification protocols/reports.
三、 平臺(tái)搭建 Platform construction
1 負(fù)責(zé)分析開發(fā)方法平臺(tái)搭建Responsible for the analytical method of building the development platform
2 負(fù)責(zé)分析團(tuán)隊(duì)平臺(tái)搭建Responsible for the analytical team platform construction
3 負(fù)責(zé)實(shí)驗(yàn)室平臺(tái)搭建Responsible for the establishment of laboratory platform
四、 項(xiàng)目管理Project management
1 協(xié)助和支持各個(gè)項(xiàng)目如期進(jìn)行Assist and support the implementation of various projects as scheduled
2 與其他同事緊密合作提供及時(shí)分析支持確保項(xiàng)目順利進(jìn)行,包括但不限于細(xì)胞株、工藝、制劑、質(zhì)控、項(xiàng)目管理、商務(wù)等人員
Work closely with other colleagues to ensure timely analytical support for project, including but not limited to cell line, process, formulation, quality control, project management and business development
五、組織管理Organizational management
1 負(fù)責(zé)團(tuán)隊(duì)建設(shè),以整體提升部門質(zhì)量管理能力和水平
Responsible for team building to improve the quality management ability and level of the department as a whole
2 工作計(jì)劃:分配下屬工作任務(wù),輔導(dǎo)下屬制訂工作計(jì)劃,明確工作目標(biāo),指導(dǎo)、監(jiān)控下屬實(shí)現(xiàn)工作目標(biāo)
Work plan: Assign tasks to subordinates, guide subordinates to make work plans, clarify work objectives, guide and monitor subordinates to achieve work objectives
3 部門會(huì)議:組織定期召開部門會(huì)議
Department meeting: Organize regular department meeting
4 預(yù)算管理:組織按照公司要求進(jìn)行本部門的預(yù)算管理
Budget management: Organize the budget management of the department according to the requirements of the company
5 績(jī)效考核:對(duì)下屬進(jìn)行績(jī)效考核評(píng)估、績(jī)效反饋溝通,輔導(dǎo)制訂績(jī)效改進(jìn)計(jì)劃
Performance assessment: Conduct performance assessment, performance feedback and communication for subordinates, and guide them to make performance improvement plans
6 團(tuán)隊(duì)建設(shè):負(fù)責(zé)部門人員需求及人才發(fā)展規(guī)劃、宣揚(yáng)公司戰(zhàn)略目標(biāo)、企業(yè)文化,協(xié)助開展部門內(nèi)部學(xué)習(xí)與文化建設(shè),營(yíng)造開拓創(chuàng)新、積極進(jìn)取的工作氛圍
Team building: Responsible for developing personal requirements and talent development plans of the department to publicize the company’s strategic goals and corporate culture, assisting in the internal learning and cultural construction of the department, and creating a pioneering, innovative and enterprising working atmosphere
7 輔導(dǎo)帶教:指導(dǎo)、培養(yǎng)部門人員提升專業(yè)能力,組織制定部門培訓(xùn)計(jì)劃并監(jiān)督落實(shí)
Guidance and coaching: guide and cultivate department staff to improve their professional abilities, organize and formulate department training plans and supervise their implementation
任職要求:
1、 本科及以上學(xué)歷要求;
2、 具有至少五年生物藥各種抗體的分析方法開發(fā)的實(shí)踐經(jīng)驗(yàn),包括但不限于單抗、雙抗、融合蛋白、ADC等。其中至少一年的分析團(tuán)隊(duì)管理經(jīng)驗(yàn),接受過與產(chǎn)品相關(guān)的項(xiàng)目管理經(jīng)驗(yàn)
Have at least five years of practical experience in the development of analytical methods for various antibodies of biological drugs, including but not limited to monoclonal antibody, bispecific antibody, fusion protein, ADC, etc. Besides, at least one year of experience in the management of analytical teams and project management experience related to the products
3、專業(yè)技能
(1). 具有直接的分析技術(shù)經(jīng)驗(yàn),如HCP,殘留蛋白A,HCD,結(jié)合活性、細(xì)胞活性,SPR或BLI,Q-PCR, 酶標(biāo)儀等
Hands on experience on analytical technologies such as HCP, residual Protein A, HCD, Binding ELISA, Cell-based assay, SPR/BLI, Q-PCR, Microplate Reader etc.
(2).有IND申報(bào)經(jīng)驗(yàn)Experience in IND filing.
(3).熟練使用辦公軟件;具有良好的團(tuán)隊(duì)協(xié)作能力以及溝通協(xié)調(diào)能力
Proficient in office software; Good teamwork and communication skills
4、具有良好的英文讀寫能力優(yōu)先;具有良好的語言表達(dá)能力
Good English reading and writing skills are preferred; Good language skills
5、具有較強(qiáng)的組織能力和管理能力
Have strong organizational ability and management ability