職位描述
1. Design and execute formulation and process using appropriate techniques.
利用相關(guān)的知識設(shè)計篩選產(chǎn)品的處方工藝。
2. Communicate and work closely with other departments on project development plan, timeline, material sourcing, equipment purchasing, in-process and finished product analysis.
與其他部門良好溝通合作,跟蹤項目開發(fā)計劃及進(jìn)度,所需原材料和設(shè)備采購計劃和要求,以及中間體產(chǎn)品和成品的的檢測分析進(jìn)度。
3. Develop product manufacturing process in pilot scale and production scale.
開發(fā)中試及生產(chǎn)規(guī)模的生產(chǎn)工藝。
4. Play a major role in process scale up, validation, and technical transfer.
指導(dǎo)工藝放大、工藝驗證和技術(shù)轉(zhuǎn)移。
5. Providing written or verbal summary report on projects and activities as required
提供書面或者口頭的項目進(jìn)展情況。
6. Writing related documents, such as, pharmaceutical development report, batch record, study protocol and SOPs.
撰寫相關(guān)文件,如:藥品開發(fā)報告,批記錄,研究方案和相關(guān)SOP等。
企業(yè)介紹
Amerigen Pharmaceuticals is a multinational company with established development and manufacturing platforms aimed at providing high-quality generic pharmaceutical products.
愛美津制藥是一家集研發(fā)和制造于一體的跨國公司,旨在向美國提供高質(zhì)量的仿制藥品。
With pharmaceutical assets and science-based expertise in the United States and abroad, Amerigen is able to provide quality products at competitive prices along with unmatched customer service.
憑借在美國和海外的制藥資產(chǎn)和技術(shù)專家隊伍,愛美津致力于提供高品質(zhì)產(chǎn)品、有競爭力的價格和無以匹敵的客戶服務(wù)。
At the end of 2007, Amerigen has successfully completed the acquisition of an oral solid dose manufacturing facility in Suzhou Industrial Park, China and established Suzhou Amerigen Pharmaceutical Co., Ltd.
2007年底,愛美津完成了在中國蘇州工業(yè)園區(qū)的口服固體制劑生產(chǎn)廠的收購,并成立了蘇州愛美津制藥有限公司。
蘇州愛美津制藥的里程碑如下:
2007 蘇州愛美津成立
2008 首次獲得美國法規(guī)文件受理
2009 首次美國食品藥品監(jiān)督管理局上市批準(zhǔn)和常規(guī)檢查
2010 獲得美國食品藥品監(jiān)督管理局的批準(zhǔn)生產(chǎn)大包裝片劑
2012 通過中國食品藥品監(jiān)督管理局再次檢查-新版GMP (2010版)
2013 通過美國食品藥品監(jiān)督管理局檢查- 4個簡化新藥被推薦批準(zhǔn)
2014 產(chǎn)品在美國市場上市, 中國市場產(chǎn)品恢復(fù)生產(chǎn)。
2015 通過美國食品藥品監(jiān)督管理局針對數(shù)據(jù)完整性的專項檢查