
藥物穩(wěn)定性高級研究員 Stability Sr. Specialist:

職位描述
Responsibilities include assisting the stability system administrator to set up cGMP stability studies for commercial drug product, product/process improvements, marketing commitments, and clinical stability for post-approval studies. Must maintain the stability database, approve all data from the stabilities studies and conduct trend analysis. Will assist with the investigation of OOS, OOT, and atypical stability results. Will assist with the writing of the stability protocol and analytical testing section of the Annual Report, as well as assist with the preparation of FDA filings, and contribute to the development of SOPs for commercial stability.Requires a BS in Chemistry or a related field with 5+ plus years of experience in the pharmaceutical industry with knowledge of regulatory and ICH guidelines requirements for stability studies. Must have some experience in the pharmaceutical stability field, significant knowledge of a variety of FDA and ICH guidance documents for drug products, and a strong analytical background. Must have extensive experience in managing various stability programs with strong understanding and knowledge of ICH guidelines and FDA stability requirements. Must be familiar with working in a cGMP environment. Must be familiar with interpretation of stability data and projecting use-time and expiration date. This job also requires attention to details and strong time management skills. Must demonstrate skills and past experience in managing multiple projects/programs and/or handles multi-disciplinary aspects of projects. The ability to work with analysts at contract laboratories and contract manufacturing facilities is essential. Experience with electronic databases is required. Successful candidates must be proactive and creative, well-organized, and have excellent communication skills. 工作職責:1.協(xié)助穩(wěn)定系統(tǒng)管理員建立藥物產(chǎn)品,產(chǎn)品工藝,市場條款和臨床穩(wěn)定性研究的cGMP穩(wěn)定性研究。2.維持穩(wěn)定的數(shù)據(jù)庫,并進行趨勢分析。3.協(xié)助編寫穩(wěn)定性協(xié)議,和年度報告中分析測試部分,以及協(xié)助FDA申報準備。 任職資格:1. 化學學士學位或相關(guān)領(lǐng)域,具有5 +多年的制藥行業(yè)的穩(wěn)定性研究監(jiān)管和ICH指導(dǎo)原則要求的經(jīng)驗。2.熟悉cGMP。3.具備電子數(shù)據(jù)庫的經(jīng)驗。 4.有良好的溝通能力。職位概覽 為配合公司實驗室建設(shè)及開展檢測業(yè)務(wù),杭州艾品公司特此招聘以下各個部門的各類層次人員 (Technician, Associate, Supervisor, and/or Managers): Analytical Chemistry; Analytical Development; Stability; Biopharma; Microbiology; Quality Assurance; Business Development & Marketing; Finance; Human Resources; MIS; ICVS; Corporate Planning & Scheduling; Purchasing & Facilities;注意:成功應(yīng)聘者將由杭州艾品公司直接聘用并提供薪酬及福利待遇。所有雇員與長三角綠色制藥協(xié)同創(chuàng)新中心或其協(xié)同成立單位(包括浙江工業(yè)大學)將無任何形式的勞務(wù)關(guān)系。聯(lián)系方式 Contact Info: 人事經(jīng)理 hr@irvinepharma-china.com 請按照下列格式書寫email主題:申請部門_職位_最高學歷_姓名。舉例,一位叫張三的申請者,最高學歷是碩士(MS),申請分析部門(Analytical Chemistry) 的HPLC Supervisor職位,則主題格式為:Analytical Chemistry_HPLC Supervisor_MS_Zhang San。同時,請按照同樣規(guī)則將所附簡歷命名。即其簡歷命名為Analytical Chemistry_HPLC Supervisor_MS_Zhang San.If using email to forward resume, please follow the renaming rules below: Department_Position_Highest degree achieved_Last name First name. For example, an applicant named Zhang San wants to apply for the position of HPLC Supervisor in the department of Analytical Chemistry. The highest degree he had is M.S. Then please write email subject as Analytical Chemistry_HPLC Supervisor_MS_Zhang San. On the other hand, please rename the resume to Analytical Chemistry_HPLC Supervisor_MS_Zhang San as well.
企業(yè)簡介
杭州艾品醫(yī)藥科技有限公司由浙江工業(yè)大學獨資創(chuàng)立,憑借與美國IPS公司的全面合作及長三角綠色制藥協(xié)同創(chuàng)新中心提供的全方位支持,專注于為意在出口制劑、原料藥等產(chǎn)品到歐美市場的在華醫(yī)藥生產(chǎn)企業(yè)提供符合美國FDA認可的全面藥品質(zhì)量檢測及其它相關(guān)服務(wù)。 長三角綠色制藥協(xié)同創(chuàng)新中心是教育部、財政部批準的首批14個“2011協(xié)同創(chuàng)新中心”之一,由浙江工業(yè)大學牽頭,聯(lián)合浙江大學、上海醫(yī)藥工業(yè)研究院、藥物制劑國家工程研究中心、浙江省醫(yī)學科學院、浙江省食品藥品檢驗研究院等作為核心共建單位,由共同致力于提升科技創(chuàng)新能力和拔尖創(chuàng)新人才培養(yǎng)能力、服務(wù)和引領(lǐng)制藥產(chǎn)業(yè)轉(zhuǎn)型升級的高等院校、科研院所、企業(yè)和國際創(chuàng)新機構(gòu)等單位聯(lián)合組成。
[展開全文] [收縮全文]浙江相關(guān)職位: 集團人資總監(jiān)
熱門區(qū)域招聘: 重慶 北京 上海 浙江 江蘇 廣東 山東 湖南 安徽 河北
浙江招聘企業(yè): 浙江佐力藥業(yè)股份有限公司 河南宛東藥業(yè)有限公司 杭州安杰思醫(yī)學科技有限公司 浙江中法制藥有限公司 貴州益佰制藥股份有限公司 福成堂大藥房 杭州杏園科技有限公司 杭州諾康醫(yī)療器械有限公司 浙江正京元大藥房連鎖有限公司 杭州明興生物科技有限公司
職位發(fā)布日期: 2015-01-16

