中裕新藥股份有限公司

1.分析方法開發與確效。熟悉蛋白質抗體藥物 HPLC 分析實驗者為佳。 2.實驗操作流程和分析報告之審閱和撰寫。 3.分析儀器之校正與保養。 4.Trouble Shooting。 5.其他主管交辦事項。

【工作內容】 1. .負責IT相關系統、硬體及軟體、儲存設備、故障排除及系統維護管理 2. 網路架構規劃建置、維護及管理、故障排除等 3. 使用者電腦軟硬體故障異常排除與技術支援 4. 日常備份管理及防毒軟體等資安系統管理 5. 資訊設備採購、資產維護管理與相關SOP文件撰寫及執行 6. 資訊安全控管的制度建立及實施 7. 主管交辦工作事項

As QC Biochemical Scientist be major responsible as below: 1. 負責生物化學成品實驗室的測試並確保測試行為並符合PICS/GMP和中裕新藥PMS的要求。 Be responsible for biochemical-drug product tests and make sure the test practice is complied with both PICS/GMP and Taimedbio PMS requirements. 2. 按時完成中控樣品測試，成品測試及穩定性樣品測試。Complete the test for in-process control samples, release product and stability test on time. 3.負責起草/修訂生物化學測試相關的SOP。Be responsible for the SOP draft/revision in QC biochemistry lab. 4. 根據GMP and GLP要求有序，有組織地書寫分析報告。To prepare the analytical reports in order and organized format. 5. 負責化學實驗室的5S管理與儀器校正及維護。perform 5S management and instrument calibration and maintenance for biochemical lab. 6. 持續優化測試效率、專業知識和設備操作/維修技能Continuous improvement on testing efficiency, analytical knowledge and equipment operation / maintenance skills 7. 準備/制定實驗室標準操作程序、在職訓練和確校計畫書與報告書 Prepare / drift lab SOPs, OJT and validation protocols/reports. 8. 直屬主管交辦的其他任務Other tasks assigned by line manager.

1. 蛋白質/抗體下游純化製程操作與管柱、溶液製備 2. 管組組裝和製程物料秤領料與退料作業 3. 生產設備校驗證文件撰寫與執行 4. 批次記錄、設備SOP及相關GMP文件撰寫 5. 協助偏差與問題調查與製程優化 6. 批次生產數據彙整 7. 協助實驗室執行下游製程開發實驗 8. 製程區域巡檢以及製程設備/環境清潔與維護 9. 需配合平假日值班及夜間警報、突發狀況緊急處理 10. 其他主管交辦事項

• 公用系統(空調系統、鍋爐、壓縮空氣、製程氣體、WFI、廢水系統)儀表校正、維護保養、再驗證、故障排除 • 中央監控系統(EMS、BMS)操作維護(包括無塵室警報處理) • GMP相關文件撰寫、歸檔 • 配合廠商施工保養，確保施工品質符合要求 • 需配合假日值班及夜間警報、突發狀況緊急處理 • 其他主管交辦事項

- 協助制定和修訂驗證標準作業程序 (SOP) - DV偏差調查報告、CAPA、EC等相關文件撰寫 - 廠房設施、公用系統(壓縮空氣、純蒸氣、水系統、空調系統)、設備驗證 (製程設備DQ、IQ、OQ、PQ等驗證) - 電腦系統確效、系統報表管理工作、稽核缺失改善 - 建立新廠設備(FAT/SAT/URS) - 協助廠內設備校正排程、預防保養排程、圖說管理、矯正維修工單管理 - 執行 QIP - 英文讀、寫能力中等 -具備良好的溝通協調能力，Team Worker -樂觀正向，主動積極，細心負責，換位思考 -支援廠務及主管交辦事項

We are seeking a drug development professional to join TaiMed's Clinical Development & Regulatory Affairs team. Play a key role in advancing innovative therapies through clinical development and regulatory pathways. - Coordinate global regulatory submissions (IND, BLA, and other CTD dossiers). - Support GMP-related change controls to ensure regulatory compliance. - Ensure efficient project execution with CROs. - Coordinating communication among internal teams and external partners, many of whom are international. **Strong English communication skills REQUIRED ** - Study scientific literature, clinical guidelines, and global regulatory requirements for drug development. - Title depends on experience.

【職務說明】： 具備策略視野與實務經驗的研發主管，領導公司新藥開發團隊，推動感染性疾病與自體免疫疾病領域之創新治療單株抗體藥物及ADC藥物研發。此職位將負責從早期藥物發現（discovery）、候選藥物篩選（candidate selection）、臨床開發（clinical program）、至製程與藥品品質控制（CMC development）等全流程之策略規劃與執行管理。 【主要職責】： • 主導並監督感染性疾病與自體免疫疾病之治療藥物開發計畫 • 評估授權機會以及與外部合作夥伴建立研發合作關係 • 整合跨部門資源，協調藥物從研究到臨床開發的各階段 • 制定並執行符合國際標準的開發策略 • 培養與領導跨功能研發團隊，提升組織研發能量 • 統籌法規、臨床、藥物安全、製造生產及品質需求，確保開發計畫順利推進 【資格條件】： • 具有藥學、免疫學、生物醫學、生技或相關領域之博士學位（Ph.D.） • 至少具備10年以上生技/製藥產業之實務經驗（不含學術訓練） • 曾參與感染性疾病或自體免疫疾病新藥開發經驗者優先 • 熟悉從候選藥物選擇、非臨床研究、臨床開發、到CMC製程發展的全流程 • 熟悉熟悉抗體以及ADC新藥ICH、FDA、EMA等藥品研發相關國際法規及標準 • 優秀的領導能力與跨部門溝通協調能力 • 具備流利的英文溝通能力（聽、說、讀、寫）

1. 規劃與執行製程技術轉移，確保可落地並符合GMP規範 2. 評估製程風險，協助異常調查與改善 3. 撰寫並整合轉移相關技術文件，協助CMC資料準備 4. 設計並執行製程優化與驗證，提升穩定性與作業效率 5. 擔任跨部門與外部製造單位窗口，負責細胞庫建構與技術支援 6. 執行主管指派事項並回報進度與成果

我們誠摯邀請具備豐富CMC經驗與卓越領導力的CMC專案團隊主管加入，主導抗體與ADC等生物藥物的藥物原料（DS）、製劑（DP）及製程開發的全程專案管理。此職位將負責領導跨部門團隊並管理國內外CDMO夥伴，確保從早期開發至後期與商業化階段的CMC工作順利執行。 此職位適合具備堅實技術背景與多年生物製劑CMC專案管理經驗之專業人才。 ________________________________________ 主要職責 • 擔任公司CMC專案負責人，主導跨部門團隊擬定策略與執行計畫，確保專案達成進度與品質目標。 • 協調製程開發、分析方法、製劑開發、品質、法規與製造等功能團隊之合作。 • 負責管理委外CDMO之藥物原料、製劑開發與製造事宜，包含技術轉移、放大與GMP生產。 • 規劃並落實CMC開發專案藍圖，包含重要里程碑、風險評估與資源配置。 • 提供CMC技術監督，並參與監管法規文件準備（IND/IMPD/BLA/MAA等）。 • 代表CMC部門參與公司核心專案團隊會議，並定期向高階主管簡報進度與挑戰。 • 支援與潛在合作夥伴的技術交流、盡職調查與聯盟管理等事宜。 ________________________________________ 工作地點： 台北市, 竹北市 資格條件 • 生物化學、藥學、化學工程等相關領域博士學位（Ph.D.）。 • 至少10年生物製劑CMC開發經驗（如單株抗體、ADC等），其中5年以上具專案領導經驗。 • 熟悉ICH、FDA、EMA等生物藥品相關法規與品質系統。 • 具備與CDMO或CRO合作管理經驗，並能有效領導跨部門團隊。 • 熟悉製劑開發、技術轉移、製程放大與GMP生產等流程者尤佳。 • 具備策略思維與良好執行力，能獨立推動專案並解決問題。 • 具備優秀的溝通能力與跨文化協作經驗。 • 英文流利尤佳。 Position Overview We are seeking a highly experienced and motivated CMC Project Team Lead to oversee the end-to-end development of drug substance (DS), drug product (DP), and associated CMC deliverables. This individual will lead internal cross-functional CMC teams and external CDMO projects to ensure project execution across all development phases—from early development through late-stage and commercial readiness. This role is ideal for a CMC expert with a strong technical background and demonstrated leadership in managing complex biologics development programs, including monoclonal antibodies and antibody-drug conjugates. ________________________________________ Key Responsibilities • Serve as the CMC project lead for TaiMed’s internal pipeline programs, accountable for strategy, timelines, and execution across all CMC functions. • Drive and coordinate cross-functional project teams (e.g., process development, analytical, formulation, manufacturing, regulatory). • Manage CDMOs to ensure deliverables for drug substance, drug product, and formulation development are met on time, within budget, and according to quality standards. • Translate development strategy into integrated CMC project plans with clear go/no-go criteria, milestones, and risk mitigation strategies. • Provide technical oversight for upstream/downstream processes, tech transfer, scale-up, GMP manufacturing, and regulatory submission support. • Collaborate closely with regulatory affairs to contribute to IND/IMPD/BLA/MAA documentation. • Act as the primary CMC representative in program core teams and communicate progress and issues to executive management. • Contribute to partner interactions, due diligence, and alliance management activities when relevant. ________________________________________ Location: Taipei or Zhubei, Taiwan Qualifications • Ph.D. in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline. • Minimum 10 years of experience in biologics CMC development (mAbs, fusion proteins, ADCs), with at least 5 years in a project leadership role. • Strong knowledge of regulatory requirements (ICH, FDA, EMA) and quality systems for biologics. • Proven experience managing CDMO/CROs and leading global cross-functional teams. • Hands-on expertise in product development, tech transfer, scale-up, and GMP manufacturing is highly desirable. • Demonstrated ability to develop and drive strategic plans and deliver on aggressive timelines. • Excellent communication, organizational, and stakeholder management skills. • Fluent in English.

Key responsibilities include the following, but are not limited to: 1. Generate Quotations: - Coordinate CDA/agreements execution - Coordinate internally to gather information required for quotation - Provide quotations/project proposal to Client and follow-ups 2. Client Communication Management - Serves as a central hub of internal/external communications with existing clients/third parties for project and product changes - Serves as a central hub of internal/external communications with potential new clients /third parties to provide proposal to meet their needs and to enhance company business opportunities - Schedule and arrange project meetings and task assignments, communicate expectations and record meeting minutes 3. Project Planning: - Establishes project charter and plan to define project scope and timeline - Assign tasks and perform follow-ups to ensure timely deliverables - Identify potential issues and risks, and solutions. 4. Project Execution and Delivery: - Drive project activity execution to meet goals/objectives and the agreed plan without compromising project deliverables or relationships - Work with Subject matter experts to propose solutions on a variety of issues with low to moderate complexity and changes - Coordinate Client Budget management including invoice management to client. - Leverage robust project management skills and co-work with project managers to drive key decisions and milestones according to the endorsed plans, timelines, costs, and quality parameters 5. Perform other PMO-related duties/tasks as assigned by Management 工作內容 1. 開發委託開發/代工(CDMO)業務、準備委託案報價單及合約簽訂 2. 負責委託開發/代工(CDMO)專案進度追蹤(業務端)與文件管理、客戶端聯繫窗口 3. 協調廠內PM與客戶溝通事宜 4. 委託開發/代工(CDMO)業務監督與管理：各專案進度掌握與彙整、收款進度管理、BD 專案人員管理

1. 審核有關各項費用支付之發票、單據及帳務處理。 2. 審核客戶應收款項帳務及帳務處理。 3. 審核其他一般會計帳務。 4. 審核營業稅、營所稅等各項稅務作業　。 5. 提出各項作業流程改善建議。 6. 完成費用暫估及編製月結報表。 7. 協助編制預算並追蹤執行進度。 8. 編製合併報表及其他分析報表。 9. 配合會計師查帳作業，並將調整分錄入帳。 10.協助公司申報公告相關事項。 11.其他主管交辦事項。