「研發主管 Head of R&D (Organ-on-a-Chip)」的相似工作

我們正在尋找一位專業且富有熱忱的科學家，負責抗體藥物的臨床前開發，並參與專利撰寫、學術發表及國內外研討會報告。理想的候選人需具備良好的抗體藥物開發與分析能力，能夠整理研發結果，並與跨部門團隊合作推動抗體藥物從研究階段向臨床開發邁進。 如果您對抗體藥物的創新開發充滿熱情，並希望參與推動突破性的生物製藥研究，歡迎加入我們的團隊！ 主要工作內容： ‧領導並分析抗體藥物的臨床前開發策略，推動專案進展。 ‧整理與解析研發數據，為藥物開發提供決策依據。 ‧撰寫專利申請，保護技術創新。 ‧發表研究成果，撰寫學術論文，並於國內外研討會進行報告。 ‧與跨部門團隊合作，確保專案從早期研究順利推進至臨床階段。

我們正在尋找一位對藥品研發充滿熱情的專業人才，能夠主動解決問題、快速理解需求，並願意投入心力實現卓越成果。加入我們，您將有機會參與開發創新產品，為醫療產業帶來真正的改變。 • 負責製劑(topical use, solution)的開發和優化，產品未來將做為醫療器材和化妝品使用。 • 執行樣品試製、分析、性能評估與品質控管。 • 撰寫產品相關技術文件與專案報告。 • 管理醫療器材和化妝品之委託代工及檢驗、查驗登記...等事項。 • 協助實驗室管理和公用設備維護保養，包含但不限於化學品管理、儀器設備維護與保養、原物料庫存管理…等等。 • 跨部門協商與團隊合作，確保開發之產品符合法規和市場需求 • 主管交辦事項

Please do submit English resume via our company website. https://fa-euzi-saasfaprod1.fa.ocs.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/2284?utm_medium=jobboard Reporting to: Lab Director, or Lab Manager Position Description: The Researcher is responsible for the conduct of analysis related works according to GCP, GLP, CAP, Standard Operating Procedures (SOP), applicable Study Specific Procedures (SSP), and local regulatory requirements. The report writer/QC is responsible for writing correspond study report/method according to study plan and Standard Operating Procedures (SOP). And to perform the quality control works. Responsibilities: General Responsibilities • Conduct analysis work following related SOPs and guidance. • Draft/check/review/approve documents, such as SOP, protocol, analytical result, report and method. • Involve in lab logistics (general affair) management, such as purchasing, inventory controlling, payment applying. • Responsible for instrument maintenances, workspace cleaning/maintenance. • Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc. • Participate in CAP/GCP/GLP/ regulatory related training courses. • Provide temporary supporting assigned by line manager. • Refer to additional Study Based Responsibilities while being assigned in analytical project. • Involve in sample collection kit/label preparation. • Involve in analytical study project management. • Other tasks assigned by line manager. Study Based Responsibility (if needed) Study Personnel in Study • All personnel involved in the conduct of the study must be knowledgeable in those parts of the Principles of Good Laboratory Practice which are applicable to their involvement in the study. • Study personnel will have access to the study plan and appropriate Standard Operating Procedures applicable to their involvement in the study. It is their responsibility to comply with the instructions given in these documents. Any deviation from these instructions should be documented and communicated directly to the Study Director, and/or if appropriate, the Principal Investigator(s). • All study personnel are responsible for recording raw data promptly and accurately and in compliance with these Principles of Good Laboratory Practice, and are responsible for the quality of their data. • Study personnel should exercise health precautions to minimize risk to themselves and to ensure the integrity of the study. They should communicate to the appropriate person any relevant known health or medical condition in order that they can be excluded from operations that may affect the study. Report Writer/Quality Control • As QC person, check and review the study data, document, report. • Involve in reference compound management, such as planning, shipping, receiving, using, storing, and disposing. And as the backup of sample manager. Qualifications: Education and Experience: • Secondary Technical school, Junior colleague, BS (Bachelor of Science) degree in Biochemistry, Biotechnology and Laboratory Science, Chemistry, or a related field. Advanced degree is a plus for Associate Researcher/ Senior Researcher. • License of Medical Technician is required for Associate Researcher/ Senior Researcher in Central Lab. Skills and Competencies: • Familiar with all lab operation activities. • Good working knowledge of CAP/GCP/GLP, applicable law (local and country) and regulatory requirements. • Good communication skills. • Good verbal and written English or other second language skills. • Good problem-solving skills. • Effective time management and prioritization skills.

1.執行藥品出口業務: 產品進出口業務，包含出貨進度、出口安排及與工廠生產排程 2.執行出口藥品安全監視 3.其他主管交辦事項 4.支援主管進行會議及內部簡報資料準備。 5.支援主管彙整國外客戶需求的送件資料。

1. 執行動物實驗、細胞試驗與分生試驗 2. 執行藥物篩選與臨床前試驗(藥理、毒理) 3. 試驗方法整理與數據分析整理 4. 藥物開發相關參考文獻搜尋與整理

1. 負責生物科技產品製程研發，協助異常改善及追蹤 2. 實驗室儀器操作(PCR, HPLC、GC、AA、FTIR...) 3. 化學物質管理及相關事宜 4. 新技術分析方法開發/規格制定及文件撰寫 5. 研發及生產用原料物樣品檢測與化驗 6. 成品檢驗與化驗、安定性試驗 7. 配合主管交辦事項 本職位擁有重要的研發職責，對公司未來發展前景具有關鍵性影響力。加入我們，您將有機會參與先進技術的研究開發，推動公司業務不斷創新發展。 我們期待有志於生物科技領域發展的您，加入我們進行先進技術的研發，共同推動公司業務不斷創新發展。歡迎有興趣的人士申請此職位。

◖為什麼你該加入台美檢驗Superlab◗ 我們是全國唯一橫跨醫學、化學及生物相關領域的檢驗科技公司。 擁有最齊全的設備、最先進儀器、最頂尖創新檢驗技術的全方位實驗室，服務項目包含一般食品、藥品、中藥、健康食品、化妝品、環境水質、化學品、紡織品、奈米產品、飲用水、醫療器材、生醫材料等。 邀請你和我們一起為消費大眾的衛生安全把關，並確保每一階段都能達到法律規範和個人期望的高標準。 ◖你將在團隊參與◗ 1. 健康食品/醫療器材/藥品臨床前試驗研究主持人 2. 臨床前試驗規劃開發、試驗流程優化、數據合理性分析 3. 實驗室GLP品質系統維運與優化 ◖我們期待優秀的☞研究主持人☜具備這樣的能力◗ 1. 具三年以上以上細胞或病毒實驗經驗 2. 具執行多年期計畫或專案經驗 ◖如果你有這樣的條件，那就太好了◗ 1. 有ISO/IEC 17025 測試實驗室管理經驗尤佳 2. 有細胞治療或再生醫療相關產業經驗尤佳

1. 獨立完成大小鼠動物實驗，需熟悉動物保定、注射、給藥、採血、犧牲、組織處理等技術。 2. 負責相關實驗操作與資料的紀錄，可獨立收集和數據分析，彙整結果撰寫實驗記錄與口頭報告，並能加以解讀實驗結果並解決問題。 3. 參與專案管理，跨部門團隊合作，確保專案從早期研究順利推進至臨床階段。 4. 協助執行臨床試驗計畫。 5. 新藥市場相關研究文獻收集與更新整理。 6. 協助主管完成各項交辦工作和任務。

如果您對次世代抗體藥物含ADC、Pro-antibody或bispecific Ab等有高度興趣且追求卓越、勇於挑戰，我們期待您的加入，一起為癌症新藥開創不一樣的未來! (1)『次世代抗體』新藥開發，含以下開發目標： - Drug discovery：候選抗體藥物篩選 - Lead optimization：次世代抗體設計與序列優化 - Lead characterization：次世代抗體之結構與功能特性分析 (2) 蛋白質(抗體)設計與表現。 (3) 其他主管交辦事項。

1.負責外泌體相關產品或技術平台的研究與開發（應用領域包含：癌症早篩、神經退化疾病、液體活檢、再生醫學等）。 2.建立與優化外泌體的分離純化方法（超高速離心、Size exclusion、商用kit、微流體技術等）。 3.開發與執行外泌體的定性與定量分析技術（如：NTA、Western blot、ELISA、qPCR、TEM、flow cytometry等）。 4.協助開發外泌體為基礎之診斷試劑、標記技術或生物載體（drug delivery）。 5.撰寫研發報告、實驗紀錄、技術規格文件與專案簡報。

1. Coordinate cross-functional groups to ensure the successful and timely completion on schedule 2. Write and review of CMC-Related Documents to ensure quality production of documents on schedule 3. Proactive identification and resolution of issues that may arise during the project. 4. Understand client's needs and collaboratively strategize to meet client's objectives

1 與主管合作，定義專案範圍、目標、行銷、風險和可交付成果，以支持發展目標。 2 專案的主導、規劃、試驗進度追蹤管理、監督、回報及時程掌控。 3 進行專案所需的內部和/或外部資源整合，使專案在最有利隻狀況下進行。 4 制定專案預算，並管理專案相關費用。 5 確保專案各項工作的臨行符合相關各國法規規範。 6 領導跨部門團隊，協調與項目成員合作研究計畫、臨床試驗，案件執行管理等相關工作。 7 維護及協助試驗相關文件記錄更新及管理，所有試驗文件檔案需整理並歸檔。 8 其他主管交辦事項。

1.細胞培養以及生物醫學研究 2.細胞製程開發相關研發 3.從事新穎細胞培養媒介物及相關產品的研究、開發與改良 4.專案管理 5.其他主管交辦事項 其他說明 由公司補助交通費用(含機票)、海外住宿 ★★★須具備細胞培養經驗1年以上。★★★ 很抱歉，若無實務經驗者請勿投遞履歷

▛你將親手打造未來細胞治療與診斷的核心技術，從實驗桌到量產線，推動產品邁向臨床與市場。 你的專業將轉化為高品質的細胞培養基與免疫分析平台，提升人類健康檢測與治療的效率與精準度。 不只是研究，更是落地應用的關鍵推手──你的每一個優化，都是對生命價值的深刻承諾 !▟ ◖為什麼你該加入啟新生技Creative◗ 我們長久以來致力於微生物研究與檢測領域，鑒於微生物學蓬勃發展、醫學診斷與工業微生物檢測需求增加，我們整合了最完整的傳統標準方法以及快速替代方法等各式微生物檢驗設備與試劑，提供各領域專業使用者選擇。 CMP® (Creative Media Plate) 是我們獨有的專屬品牌，也是台灣第一家通過行政院衛福部體外醫療器材的 IVD-GMP 培養基製造工廠，更是目前國內規模最大的培養基供應商。 我們除了自身品牌 CMP® 外，同時也引薦國際優質產品，使台灣的微生物診斷與檢驗水準更趨完整與國際並進。 ◖你將在團隊參與◗ 1. 細胞培養基與試劑耗材開發及優化。 2. 建立免疫細胞平台模型，開發分析技術與確效。 3. 優化量產流程，提升產品品質與生產效率。 4. 協助產品認證與專利申請。 5. 完成其他主管交辦的專案或任務。 ◖如果你還有這樣的條件，那就太好了◗ 1. 生物醫學、藥理學、藥物化學或相關領域的學士或碩士學位。 2. 細胞操作技術至少1年，免疫細胞、幹細胞或原代細胞培養經驗佳，臨床檢體處理經驗佳。 3. 具備管理研究案件的經驗，能夠有效管理多個研發項目。 4. 具FACS、ELISA、PCR生物技術操作。 ◖工作地◗ 目前主要工作地點為新北五股廠區，竹北廠區建成後轉至竹北生醫園區（預計2025H2）

Key Responsibilities: • Lead and support IND-enabling studies. • Optimize immune cell culture processes for enhanced efficiency and quality. • Initiate and develop new projects on an annual basis. • Participate as a core team member in manufacturing cell therapy products in a GTP-compliant laboratory. • Perform quality control (QC) testing to ensure product safety, stability, and efficacy. • Establish, manage, and maintain comprehensive documentation systems in compliance with regulatory requirements. Qualifications • Strong passion for research, self-motivated, and a collaborative team player eager to engage in the global cell therapy drug development field. • Excellent communication and interpersonal skills. • Proficiency in flow cytometry-based experiments (required). • Experience with tumor-killing assay experiments (preferred). • Familiarity with GTP laboratory practices (preferred). • Experience in CAR-T cell processes, stem cell processes, and exosome-related manufacturing processes (preferred). We are seeking a highly skilled and passionate Chief Researcher to join our CMC team in advancing innovative cell therapies to fight cancer. In this role, you will work in a dynamic, collaborative, and multidisciplinary environment, driving breakthrough therapies from bench to bedside and making a lasting impact on global healthcare and human well-being.

1. 生體可用率/生體相等性試驗(BA/BE)規劃執行與專案管理 2. 臨床/臨床前試驗與檢體分析(PK/ADA)專案管理 3. 協調整合試驗團隊成員與外部協同合作單位之進度 4. 主導專案起始/規畫/執行/監控/結案分析並進行風險管控 5. 依目標需求控管試驗品質/時程/成本 6. 試驗委託單位聯繫與合約時程經費掌握 7. 主管交辦事項

This vacancy is open for talent pool collection. We will contact you if we have proper vacancies that fit with your profile. Job Mission Represent manufacturing and act as gatekeeper from manufacturing to D&E function Add value in overall manufacturing processes such as forming, machining, joining, and assembling Job Description Contribute to the solution of faults and takes the necessary initiatives and practical decisions to ensure zero repeat Identify gaps and drive assigned process improvement projects and successful delivery Initiate and drive new procedure changes and projects Develop and maintain networks across several functional stakeholders Prioritize works and projects based on business situation Transfer knowledge and train colleagues on existing and newly introduced products Education Master degree in technical domain (e.g. electrical engineering, mechanical engineering, mechatronics) Experience 3-5 years working experience in design engineering Personal skills Show responsibility for the result of work Show proactive attitude and willing to take initiative Drive for continuous improvement Able to think outside of standard processes Able to work independently Able to co-work with different functional stakeholders Able to demonstrate leadership skills Able to work in a multi-disciplinary team within a high tech(proto) environment Able to think and act within general policies across department levels Diversity and inclusion ASML is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, veteran status, disability, sexual orientation, or gender identity. We recognize that diversity and inclusion is a driving force in the success of our company. Need to know more about applying for a job at ASML? Read our frequently asked questions.

1. 美國實驗室管理與營運 －負責美國實驗室管理與營運，包含：實驗器材保管、試驗材料採購與管理、實驗室營運相關行政管理事宜。 2. 執行臨床試驗 －執行臨床試驗相關實驗室操作、完成病理服務實驗流程與產出成果；撰寫實驗記錄、業務報告、會議討論紀錄。 3. 專責美國臨床試驗／委託試驗／合作案之聯繫窗口 －(1) 擔任美國合作與委託試驗之主要聯繫窗口，負責合作業務之後續溝通聯繫，試驗規劃與執行、追蹤成果等事宜。 －(2) 針對美國臨床合作、實驗室營運等事宜，定期與總部進行討論會議與營運拓展報告。 4. 推動JelloX美國病理服務方案 －協助美國地區病理服務方案之推動，包含：服務方案介紹、業務洽談、研討會或展覽實地宣傳。 5. 其他交辦事項： －執行其他與美國實驗室相關之臨時交辦事項。 ＊本職缺，於臺灣完成受訓後，需長期外派美國亞利桑那州。 【薪資計算方式為，臺灣培訓薪資，外派薪資另議】

1. Formulation design of oral, parenteral and topical product. 2. New drug delivery platform development for 505(b)2 candidate. 3. CMC preparation global submission. 4. Patent survey for new candidate and by-pass formulation design. 5. Trouble-shooting of existing commercial products.

• Providing technical expertise/scientific input on formulation development strategies • Preparation and practical execution of formulation development projects • Providing scientific expertise and formulation insights to Core Teams meetings • Review test results in alignment with the project goals, identify causes of variances and recommend solutions to achieve goals. • Supporting the scale-up of developed formulations and bringing them to GMP manufacturing • Schedule experiments and prioritize assignments to meet project objectives and deadline. • Maintain laboratory equipment and chemicals in a safe manner. • Responsible for writing up R&D documents and research reports.