「研發課長/副課長-湖口」的相似工作

We are seeking a highly motivated and innovative R&D Scientist to join our pharmaceutical development team. The successful candidate will contribute to the design, formulation, development, and optimization of drug products, with a focus on quality, scalability, and regulatory compliance. This role offers the opportunity to work in a collaborative environment with cross-functional teams including Regulatory, Analytical/QC, Quality, Manufacturing, and Business Development. 1.Conduct research and development of new drug formulations for Global Regulated markets (Nasal – Solution, Spray, DPI, pMDI etc.) 2.Follow Quality by Design to plan & execute lab-scale experiments, stability studies, and process development activities including DOE. 3.Responsible for managing monographs, validated excel sheets, approved reports (paper and electronic), notebooks and document archival. 4.Develop & optimize manufacturing processes in compliance with cGMP requirements. 5.Participate in Technology transfer to manufacture pilot, scale up, submission & commercial batches. 6.Prepare technical documents, as per cGMP & ICH for execution and manufacturing including batch records, protocols and reports. 7.Prepare regulatory submission documents as pe ICH including chemistry manufacturing & controls (CMC), product development report, overall quality summary (OQS) etc. 8.Execute CCR, deviation investigation, CAPA, LIR, SOP preparation, internal and support GMP inspection. 9.Stay updated with scientific & global regulatory advancements and ensure knowledge sharing with co-workers. 10.Collaborate with cross-functional teams on project timelines and deliverables

1. 微生物檢驗方法開法及確效(含產品/原料、消毒劑效能、防腐效能) 2. 原料及產品微生物放行檢驗 3. 工廠純水系統水質檢測 4. 工廠微生物環境監控 5. 微生物實驗室相關之儀器/設備校驗 6. 微生物實驗室相關之試劑、耗材及菌株等管理 7. 微生物實驗室運作及微生物檢驗相關之文件製備

1. 配方研究試製 2. 製程技術開發與轉移 3. 協助量產與製程優化 4. 新產品開發評估 5. 查驗登記資料撰寫 6. 實驗室管理。 歡迎 所有求職者

工作內容： 1.自研專案管理（含內部驗證、前臨床或臨床試驗）：規劃與執行研發專案，包含文獻蒐集、計畫書撰寫、時程與預算控管、成果發表。 2.政府補助計畫執行：撰寫與管理政府計畫，包括簡報、費用與進度追蹤、查核資料準備及行政作業。 3.自研產品的科學驗證：負責驗證規劃、實驗執行、數據彙整與報告/成果發表。 4.藥物分析方法開發：建立並確效蛋白質、小分子藥物、特殊劑型或新材料之分析方法。 須具備的能力： 1.溝通力強，能與不同部門順暢協作 2.熟悉專案管理流程，能獨立規劃與執行專案任務 3.具備創新思維與問題解決能力，能獨立開展研究並提出具體可行之構想 4.能適應多元工作內容，對新任務抱持開放心態 需求條件： 1. 醫藥、生物、化學背景碩士學位 2. 2年以上工作經驗 加分項目： 具備良好英文能力，IELTS 6.5 或 TOEFL iBT 80 分以上

1.品質管理系統: 偏差調查/OOS/OOT、CAPA、變更管制、內外部稽核、客訴管理、人員培訓與資格認證管理 2.供應商管理: 原物料供應商、運輸商、委託合約製造CMO、委託化驗CTL、委託校驗、服務提供者 3.趨勢分析及風險評估 4.產品放行與品質審查 5.設備及設施管理 6.安定性留樣品管理 7.文件管理 8.國內外查驗登記資料彙整 9.執行主管指派的其他任務

1.主導/協助跨部門擬定CMC策略與執行時程規劃。 2.負責管理公司內部及客戶專案的CMC資料與相關法規文件。 3.作為委外專案之管理者及聯繫窗口。 4.支援客戶或委外專案之技術交流與法規面評估。 5.協助逐漸建立專案管理部門。 6.主管交辦事項。

1.西藥製藥廠QC主管經驗。 2.綜理日常原料藥、成品檢驗、水系統及環境監測之執行確效活動之檢驗及其COA之準備。 3.QC SOP之撰寫與更新&OOS及Deviation事件之調查及CAPA擬定。 ---------------------------------------------------------------------------------------- 選擇Otsuka，與世界級的製藥職人共創未來！ ~~中壢工廠特有福利~~ 一、優渥薪資與福利 1. 保證14個月年薪，盈餘時發放年度紅利獎金。 2. 免費中餐、加班誤餐費、全新員工餐廳即將改建，舒適又貼心。 二、健康與生活平衡 1. 優於法令的年度健檢，專業醫護及免費心理諮詢，全面守護身心。 2. 豐富的CSR公益活動、家庭日、員工旅遊、春酒/尾牙，樂趣無限。 三、便利交通與穿搭 1. 免費機車停車位，中壢工業區稀有免費汽車停車位（每年抽籤）。 2. 提供冬夏Polo衫及外套當工作服，出門即有型，穿搭無煩惱。 四、國際職涯發展 全額補助海外研修，前往日本、越南、韓國、西班牙等地，拓展全球視野。 立即投遞履歷，成為Otsuka的一員！

1.協助實驗室工作安排/經營管理與技術支援 2.撰寫專案研究計畫書及報告(中/英文) 3.協助或輔導客戶在專業技術上說明,討論與溝通

Please do submit English resume to our company website. https://fa-euzi-saasfaprod1.fa.ocs.oraclecloud.com:443/hcmUI/CandidateExperience/en/job/1488?utm_medium=jobboard General Responsibilities: Manage staff in accordance with organization's policies and applicable regulations, including without limitation: planning, assigning, and directing work; managing performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; acting as a coach and mentor for subordinates as they develop in their role. Participate in the selection and onboarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs. Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable. Maintain lab daily operation. Ensure the quality and timely of lab deliverable. Perform the tasks assigned by line manager. Refer to additional GLP/GCP Regulation Required Responsibilities while involved in GLP organization. As the member of test facility/site management. Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc. GLP/GCP Regulations Required Responsibilities (if needed): Lab Manager Maintain an internal responsibility chart which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by the Principles of Good Laboratory Practice. Ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study. Ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual. Ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions. Ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the Study Director before the study is initiated. Replacement of a Study Director should be done according to established procedures, and should be documented. Ensure, in the event of a multi-site study, that, if needed, a Principal Investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a Principal Investigator should be done according to established procedures, and should be documented. Ensure documented approval of the study plan by the Study Director. Ensure that the Study Director has made the approved study plan available to the Quality Assurance personnel. Ensure the maintenance of a master schedule. Ensure that test facility supplies meet requirements appropriate to their use in a study. Ensure for a multi-site study that clear lines of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel. Ensure that test and reference items are appropriately characterized. Ensure that appropriate and technically valid Standard Operating Procedures are established and followed, and approve all original and revised Standard Operating Procedures. If necessary, function as Study Director for specific study, in this case, he/she must not have the responsibility of test facility/site management role in the study.

1. Establish a stability database for annual product reviews and product attribute statistics. 2. Stability program management 3. Supplier qualification, internal audits 4. Monitor and implement cross-contamination prevention measures 5. Cleaning validation and verification management 6. Assign as requested by supervisor. 該員工主要負責APR (stability section), Stability program management, shipping study

1. 具專案執行經驗 2. 文獻搜尋、簡報整理、研究計畫撰寫 3. 具細胞培養/疾病或藥物開發經驗 4. 實驗室環境、設備及耗材管理維護 5. 其他主管交辦事項

1. 原料、賦形劑、成品及包材檢驗分析 2. 分析方法之開發及確效 3. 成品安定性試驗執行 4. 藥品查驗登記技術資料(CTD)撰寫 歡迎 所有求職者

工作內容： (1) ELISA檢測抗體與試劑開發 (2) 磁珠Antibody Coating (3) 磁珠based ELISA檢測試劑開發

1. 新藥與學名藥的處方篩選之方法開發及運用 2. 成品分析方法開發, 方法確效(validation), 檢驗規格設計與化驗工作 3. 原料藥, 賦形劑分析方法測試, 檢驗規格設定, 方法確認(verification)與化驗工作 4. 運用US, EU, JP, CN, KR和TW等各國法規, 配合ICH及GMP規則, 撰寫及審閱CMC相關文件, 以及國內外查驗登記之回覆相關檢驗工作 5. 分析技術之開發, 國內外之技術轉移 6. 對研發有強烈的熱忱及興趣者尤佳, 我們的環境和歷練可訓練您成為業界頂尖的研發人員

1. HPLC、GC分析方法開發 2. 安定性試驗設計及報告撰寫 3. 撰寫品質文件 4. 執行ISO與GMP相關業務 5. 協助原料、半成品、成品檢驗業務 6. 協助實驗室校正與維護作業

We are seeking a highly motivated and innovative Analytical R&D Scientist to join our analytical research & development team. The successful candidate will contribute to the analytical method development for formulation, and analytical support optimization of drug products, with a focus on robust analytical methods, quality, technology transfer, and regulatory compliance. This role offers the opportunity to work in a collaborative environment with cross-functional teams including Formulation, Regulatory, QC, Quality, Manufacturing, and Business Development. 1.Support for analytical method development and R&D batches stability for drug formulations for Global Regulated markets (Nasal – Solution, Spray, DPI, pMDI etc.) 2.Perform analytical method development with AQbD, formulation screening, finished product testing, stability study, compatibility studies, RLD reverse engineering, technical transfer, and laboratory-related work during the development stage. 3.Support ANDA submission and complete drug development lifecycle management. Knowledge about analytical methods for pMDI, DPI and nasal spray for US and EU markets. He should be well versed with techniques as, HPLC, Next generation impactor, DUSA, APSD, Plume geometry, breathing simulators, Malvern Mastersizer, MDRS, LCMS for Nitrosamine, Dissolution and related techniques. 4.Perform literature search, patent landscape review, and regulation comparison. Review guidelines and API vendor DMF. Read the pharmacopeias and technical documents to understand the latest knowledge of the OINDP pharmaceutical industry. 5.Participate in Analytical methods Technology transfer to GMP labs to support for manufacture pilot, scale up, submission & commercial batches. 6.Adequately utilize and maintain analytical instruments/equipment. Diagnose and identify solutions to resolve analytical instrument issues. Perform calibration, qualification, and preventive maintenance. Support for procurement and qualification of new analytical instruments/software 7.Review the documents and electronic records. Prepare analytical protocols, reports and CMC documents. Monitor data trending and support for deficiency letter response. Ensure good documentation practices and data integrity. 8.Execute CCR, deviation investigation, CAPA, LIR, SOP preparation, internal and support GMP inspection. 9.Train and mentor analysts in day-to-day laboratory operations. Support relevant departments and customers to complete projects on time. Ensure all activities and analysis comply with applicable GMP, correct procedures, regulatory guidelines, and health and safety regulations 10.Responsible for managing monographs, validated excel sheets, approved reports (paper and electronic), notebooks and document archival 11.Support laboratory management work, e.g., reference/working standard management, instrument management, work area cleaning, reagents and solvents, and other supporting systems 12.Prepare technical documents, as per ICH requirements for analytical method development, protocols and reports. 13.Prepare regulatory submission documents as pe ICH including chemistry manufacturing & controls (CMC), method development report etc. 14.Stay updated with scientific & global regulatory advancements and ensure knowledge sharing with co-workers 15.Collaborate with cross-functional teams on project timelines and deliverables.

*前1~2年工作在「台中廠」培訓，之後開始在「竹北廠」上班。 ●環境與水質採樣及其相關檢驗，微生物/內毒素試驗分析 ●微生物鑑定 ●執行空調系統驗證與水系統驗證 ●培養基效能驗證、高壓氣體採樣 ●微生物檢驗/監測異常事件調查 ●設備維護及校驗執行 ●分析方法SOP制定

1.儀器驗證 2.分析設備維護 3.原料及成品規格制訂及分析 4.分析方法找尋 5.分析方法確效 6.溶離比對 7.安定性樣品分析 8.查驗登記協助 9.補件程序作業 10.主管交辦事項

1.藥物分析方法建立、開發及制度建置。 2.實驗室儀器設備之驗證、保養、維護與改善之計劃擬訂與監督管理，確保設備有效運轉，管制良好，功能正常，量測結果符合品質之要求。 3.熟PIC/S GMP規範。 4.其它主管交辦事項。

1. 執行產品生產製造或原料,成品品質檢測 2.生產/檢驗設備操作與工作區域日常維護 3.紀錄生產及品管數據,確保符合公司內部SOP規範與法規要求 4.執行環境監控並遵守無菌操作規範 5.協助異常狀況處理,並參與程序書改善與優化