藥華醫藥股份有限公司

We are seeking an experienced and strategic scientific leader to join our R&D leadership team as the Head of Protein Science and Process Development. The successful candidate will bring deep technical expertise in biologics development, strong leadership capabilities, and a proven track record of advancing biologic candidates through the development lifecycle. This position will lead cross-functional teams responsible for developing robust, scalable, and compliant manufacturing processes for Discovery Research, Clinical, and Commercial Productions. Key Responsibilities • Lead the preclinical production team to support discovery research by enabling early-stage protein candidate screening and evaluation across a diverse biotherapeutics pipeline, including cytokines, monoclonal antibodies, and bispecific proteins. • Lead and manage all CMC Process Development activities (cell line, cell culture, purification, analytical, and formulation development) for protein-based biotherapeutic products using E. coli and CHO expressing systems. • Implement technological tools to enhance product development, scaling, and troubleshooting processes. This includes utilizing Design of Experiments (DoE) and conducting thorough risk assessments. • Oversee the technology transfer to GMP manufacturing facilities to ensure consistent performance in both clinical and commercial production. • Contribute to CMC strategy, ensuring robust, scalable, and regulatory-compliant processes to support IND/IMPD and commercial production. • Collaborate with quality, regulatory, and manufacturing teams and ensure compliance with ICH, FDA, EMA, and other global regulatory requirements for organizational & pipeline milestone deliverables. • Work closely with cross-functional teams in discovery, pharmacology, toxicology, quality, regulatory, and program management to align scientific strategy with project milestones. • Develop compelling team vision and strategies for sustained technology platform innovation and operational excellence. • Participate in R&D leadership discussions and work with executive management to drive strategic alignment, resource planning, and execution of development programs.

1. Collaborate with cross-functional teams to ensure adherence to GCP standards and regulatory requirements throughout the BLA submission process. 2. Perform quality assurance audits of clinical trial data, ensuring data integrity, consistency, and compliance with established protocols and regulations. 3. Develop and maintain quality systems and procedures related to GCP compliance and BLA submissions, identifying areas for process improvement and implementing corrective actions as necessary. 4. Provide guidance and support to project teams on GCP compliance issues, regulatory requirements, and best practices for BLA submissions. 5. Coordinate with regulatory affairs personnel to prepare and compile documentation for BLA submissions, ensuring timely and accurate submission to regulatory authorities. 6. Stay abreast of changes in regulatory requirements, industry trends, and best practices related to GCP compliance and BLA submissions and communicate updates to relevant stakeholders.

1. Serves as global level project manager from sponsor end (perform and participate in project development process and CRO and vendors selection, review core document/procedure, etc.) 2. Meet country goals through project strategy planning/execution in collaboration with project members. 3. Ensure study conduction with speedy and good quality through project leadership with internal cross functional teams, CRO Oversight, Issue management, CRO oversight monitoring visit and etc. 4. Initiates and maintains relationships with Investigator according to assigned therapeutic area. 5. Support and lead country activity to enhance cross-functional department cooperation according to assignments. 6. Perform other duties as assigned.

1. 領導和管理新藥研發 (drug discovery) 專案, 以及交付臨床 drug candidate (PCC) 的記錄 2. 執行ADC專案，包括協調與管理小分子合成藥物之專案 3. 具有有機合成化學方法的專業知識，能夠同時在多個專案上成功地領導進行 ADC 新藥研發 4. 對候選藥物的選擇和評估擁有深入了解，同時在細胞/分子生物學、疾病藥理學、藥物代謝機制和分子毒理學、藥物動力學和藥效學方面有豐富的專業知識。

<生物新藥製藥業> 1. 負責品管實驗室管理以符合cGMP規範的品質要求並確保實驗室資源運用、儀器設備、人 員管理，檢驗排程皆能符合生產需求。 2. 審閱化學檢驗相關分析方法確效及規格、抽樣指令、檢驗方法等文件制修訂皆符合藥典規 範。 3. 審閱微生物檢驗相關分析方法確效及規格、檢驗方法以及環境監控計畫等文件制修訂皆符合藥典規範。 4. 審閱產品安定性計畫書及安定性管理。 5. 審閱原料及產品放行檢驗及安定性檢驗報告。 6. 負責實驗室各項變更管制執行及實驗室數據超標(OOS)等調查。 7. 內外部稽核準備及應對，確保實驗室和品管流程符合相關法規和標準，並追蹤稽核後的改進措施。 8. 其他主管交辦事項。

執行公司內部臨床試驗，您將作為 PMS (project management specialist)，根據專案的時程接觸到 CTA/SSU/CRA/RA相關事務 1. 管理及協調CRO、SMO、中央實驗室及研發團隊，特別針對細胞治療專案，追蹤試驗進度與技術需求，並必要時更新實驗室手冊，確保符合GTP及相關品質標準。 2. 負責臨床試驗計畫書變更之FDA及IRB送審，供應商合約簽署與費用管理。 3. 確保試驗藥品及細胞治療產品的供應與使用，必要時更新藥品手冊，並協助監控細胞治療產品的製備、運送及品質控管。 4. 追蹤試驗偏差與不良事件（AE/SAE），協助制定及執行矯正與預防措施（CAPA）。 5. 整理試驗資料與品質控管，確保數據完整並符合GCP、GTP及法規要求。 6. 與跨部門及試驗中心保持良好溝通協調，支持專案管理及問題解決，並配合細胞治療專案的特殊合規要求。

1. 日常公司會計作業與稅務申報 2. 執行及監管子公司(國內及國外)財務會計作業 3. 協助整併各子公司預算及預算控管 4. 管理報表編制及分析 5. 申請租稅優惠及免稅案件、確保符合相關法規要求 6. 執行主管交辦事項

1.參與集團內SAP ERP導入專案. 2.負責集團SAP ERP系統 PP/QM 模組之日常維運. 系統分析設計. 程式開發及問題排除. 3.系統整合及串接，與BPM系統進行整合開發. 4. GMP 相關文件撰寫 5. Dashboard report 開發 (運用SAP Business Data Cloud) 6.協助 AI 專案推行 7. 其他主管交辦事項.

1.HRIS System Management and Optimization Manage daily maintenance of SAP SuccessFactors, update employee data and organizational structure, and regularly evaluate system performance to drive functional improvements. 2.Cross-Department Collaboration and Project Management Act as a liaison between HR, IT, and external vendors; plan system integrations (e.g., API connections), develop features, and manage project timelines. 3.User Support and Training Provide operational support and troubleshooting for branch users; conduct training sessions to enhance system proficiency. 4.HR Data Analysis and Reporting Ensure data accuracy and integrity, consolidate cross-system data, and generate real-time HR reports to support decision-making. 5.Process Standardization and Digital Transformation Develop and maintain HR system manuals and SOPs; lead HR system implementation and optimization projects to improve efficiency and decision quality.

We are looking for a proactive and detail-oriented candidate to support our management team and enhance collaboration between HQ and our global subsidiaries. This role provides an opportunity to work in an international environment and develop strong cross-cultural communication skills. Responsibilities • Review subsidiary documents and expenses for managerial approval • Coordinate management meetings, schedules, and travel arrangements • Prepare presentations and gather supporting materials • Facilitate smooth communication and collaboration between HQ and subsidiaries • Other tasks assigned by supervisors Qualifications • Strong English reading and writing skills; intermediate speaking ability • Excellent coordination and cross-cultural collaboration skills • Positive, proactive, and detail-oriented • Proficient in Microsoft Office; experience with AI and digital tools is a plus

1. 生技廠建廠階段五大管線系統監造及驗收 2. 生技製程發包工程監造 3. 工程驗收及確效驗證文件撰寫 4. 電力系統/空壓/鍋爐/氣體等支援系統維護運轉

1.新建工地協議組織運作監督與溝通協調。 2.負責新建工地安全衛生查核。 3.環保(空、水、廢、毒)許可申請追踨。 4.個人防護具、採購管理、承攬管理及變更，安全衛生作業標準、機械、設備或器具之管理。 5.定期檢查、重點檢查、作業檢點及現場巡視。 6.緊急應變措施。 7.安全衛生管理紀錄及績效評估措施。 8.熟悉環保、消防及職業安全衛生相關法令。 ※先於「台中廠」培訓3個月

1.原料秤取 2.培養基/配製緩衝液配製 3.廠區環境消毒維護 4.製程器具清潔/包裝滅菌 5.台中/竹北GMP文件撰寫與改版 6.其他主管交辦事項

1. 參與PEG製程及其它製程相關工作事項 2. GMP相關文件撰寫:如SOP、校驗證文件 3. GMP廠區環境例行性維護 4. 設備例行性維護、校驗證 5. 其他主管交辦事項

1. 藥品調劑/充填/包裝等相關作業 2. 製程/設備等相關確效/校驗證執行 3. GMP文件撰寫/修訂 4. 針劑廠相關專案業務推動 5. 其他主管交辦事項

加入我們的新藥研發團隊，您將負責水系統與生產環境的監測，確保產品製程符合品質標準 1.水系統取樣與微生物檢測 2.生產環境監測與粒子（Particle）檢測 3.產品微生物限度檢測（Bioburden） 4.水系統與產品之內毒素測試 5.菌種鑑定與相關分析方法文件的撰寫 6.檢驗設備的日常維護、驗證與校正

加入我們的新藥研發團隊，您將參與原料與產品的品質檢測及分析方法開發，確保新藥研發過程與產品皆符合最高標準。主要工作內容包括： 1.原料與物料檢驗，原物料規格的建立與確認 2.水系統化學分析、產品純度檢測 3.分析方法確效計畫書撰寫與執行，相關 SOP 的制定與優化 4.產品製程中控（IPC）、放行檢測與安定性試驗計畫的設計與執行 5.實驗室設備操作標準（SOP）建立、設備校驗與維護

*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

*前1~3年工作在「台中廠」培訓，之後開始在「竹北廠」上班。 ●原物料、IPC、產品、安定性樣品、水質之內毒素分析 ●生物活性試驗Bioassay、host cell DNA、host cell protein、sterility等項目例行檢測 (放行檢測、安定性檢測) ●異常事件調查 ●設備維護及校驗執行 ●分析方法SOP制定 ●實驗室LIMS系統 ●其他主管交辦事項

1. ADC及抗體藥物等細胞平台分析方法開發執行 如: ELISA-based, Flow cytometry (cytokine Cytometric Bead Array; CBA), RGA, ELI-SPOT, ICC & IF, 冷凍PBMC實驗操作 、Immune cells culture、Effector/Target cells cytotoxicity assay, 2. in vivo study dessignanalytical supporitng and CRO monitor 3. 3D腫瘤細胞藥篩平台建立和執行及新偵測方法研究開發 4. 擔任專案與部門聯繫窗口 5. 執行學研單位合作案 ▍能力需求 1. 需具有免疫學、藥理學、細胞生物學或癌症醫學之背景 ▍更了解 藥華醫藥 PharmaEssentia 公司研發進程與能力： https://hq.pharmaessentia.com/tw/pipeline