求職服務專線
台北 02-2912-6104 轉 2
   02-7703-3104 轉 2
意見回饋
廠商求才專線
台北 02-2912-6104
   02-7703-3104
台中 04-3700-6104
上海 86-21-50277104 轉 1
意見回饋

R&D- Sr. Manager / Manager (Management and Operation, CMC)

  • 全職

The CMC manager will oversee manufacturing activities and for OBI projects for all phase clinical development. The CMC manager will also work closely with other departments to shape manufacturing, supply including technology transfer to CMO or CDMO and monitor closely the manufacturing of drug substance and drug product. The individual should be experienced in preparation of CMC regulatory documents (module 3) for clinical project submissions and has an in-depth understanding the regulatory guideline.

Primary Duties and Responsibilities, including mental requirements of position:

1. Develop and provide manufacturing strategy in time for clinical project lunch and supply.
2. Responsible for monitoring the manufacturing processes in CDMO and ensure consistency in product quality. Responsible for ensuring GMP compliance with manufacturing sites and assist in GMP audit if required
3. Responsible for providing technical support and troubleshooting in manufacturing processes for CDMO
4. Work closely with cross-functional groups within R&D and at other site (CDMO) in planning and development and implementation of tasks related to manufacturing.
5. Preparation of global CMC Regulatory strategy document for assigned clinical product submissions. Familiar with eCTD structure and participate in technical writing in CMC and quality aspect (Module 3) in dossier for registration purpose

工作條件

  • 工作經歷: 五年以上
  • 學歷要求: 碩士以上
  • 語文條件: 中文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
    英文 -- 聽 /中等、說 /中等、讀 /精通、寫 /精通
  • 工作技能: 原料及產品品質管制監控、執行產品可靠度測試與問題分析、規劃並執行品質管理系統、生產程序改良與開發、製程相關技術開發
  • 其它條件: • PhD degree in life sciences in chemistry, molecular biology, or similar is required. Advanced degree preferred.
    • At least 5 years’ experience in GMP manufacturing environment either in upstream and downstream processes in antibody therapeutics field.
    • Minimum of 3 years relevant CMC experience in preparation of CMC regulatory documents (module 3) and maintenance.
    • In depth knowledge in process development and troubleshooting skills, manufacturing life cycle, manufacturing comparability and can review GMP documents (master batch record, test records, COA etc)
    • Experience with IND, CTA, NDA, MA fillings and thorough knowledge of relevant FDA or EMA regulations and guidelines


  •  
  • 歡迎夜間就讀中、外籍人士、原住民【相關法令】、二度就業、中壯齡(45~54歲)、中高齡(55~64歲)

福利制度

法定項目

其他福利

「獎 金 」:生日禮金、三節獎金
「休 假 」:週休二日、陪產假、年假、有薪病假5天、第一年即享有10天(以上)特休
「保 險 」:勞、健保、意外險、壽險、員工體檢、勞退提撥金
「補 助 」:結婚、生育、教育訓練補助
「其他 」:按摩、員工旅遊(全員出遊)、交誼津貼、交通津貼、彈性上下班(中午休息1.5個小時),飲料點心免費提供、家庭日、聖誕晚會、密室脫逃等活動與太極、登山、羽球、藍球、路跑社等社團。

更新日期:2022-01-26

應徵方式

  • 職務聯絡人: Neo Lu (盧先生)
  • 聯絡E-Mail: (請利用104履歷表應徵此工作) 我要應徵
  • 洽: 不接受電洽
  • 洽: 不接受親洽

應徵分析

兩週內0-5人應徵
經歷分佈
新鮮人0%
1~3年0%
3~5年0%
5~10年0%
10年以上100%
學歷分佈
碩士及以上100%
大學0%
專科0%
高中0%
高中以下0%
一零四資訊科技享有網站內容著作權 © 2001- 2022 104 Corporation All Rights Reserved