「美國實驗室經理（外派美國）」的相似工作

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.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

◖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。

1. 規劃各新藥開發案產品發展策略：進一步了解全球生技產業之研發趨勢、機會與相關資訊蒐集，並且擬定各目標市場之臨床開發策略與執行計畫。 2. 開發與建立目標市場重要合作專家夥伴關係，確保各臨床試驗案於目標市場之品質、速度與成功，並協助全球品牌價值維護：維護外部夥伴與重要領域專家關係。 3. 發現新的臨床研究機會：與外部關係建立與互動，從中發現新的研究與機會點。 4. 教育訓練：內部員工和外部客戶(醫師、護理師或個管師等)

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. 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.

【主要工作內容】 (一)GMP合規之放射性藥品生產（國際級高防護與高氣密性設備）。 (二)GMP合規之放射性藥品之無菌充填（獨特台灣專利鎢罐保護）。 (三)生產設備及儀器維護保養。 (四)生產記錄報表製作與分析。 (五)撰寫工作相關SOP。 (六)其他主管交辦事項。 ※工作須提重物（10公斤） 【加分項目】若您同時具備以下條件很加分。 (一)具藥廠或無菌製劑經驗尤佳。 (二)具二年以上化學實驗或有機合成相關經驗尤佳。 (三)具「輻射安全證書」尤佳。 (四)具「輻防相關證書」尤佳。 (五)放射線相關科系畢業者尤佳。 【專有的工作津貼與獎金項目】 (一)依工作時間計有夜班津貼。 (二)因應公司發展，執行並完成特別專案則另計專案獎金。 (三)「輻射安全證書」證照加給。 (四)「輻防相關證書」證照加給。 ※普瑞默為與國際知名公司合作建置之藥廠，且有專業輻防團隊駐廠指導，能全方位保障所有同仁輻防安全，我們非常歡迎並期待具備相關經驗或有興趣參與台灣核醫製造的您投遞履歷表，讓我們有機會一起聊聊，以尋求彼此合作的機會。 《加入普瑞默生技，與我們一起挑戰世界》

Pythia Biotech is a Taiwan-based startup dedicated to accelerating cancer drug development, immunotherapy, and precision medicine through Organ-on-a-Chip (OoC) technologies. We are expanding our team and seeking a Head of R&D to lead research, drive innovation, and advance translational applications. This is a rare opportunity to join a fast-growing startup, work alongside a world-class advisory team, and take on a pivotal leadership role as the company scales. Job Responsibilities •Develop and execute R&D strategies to support oncology and immunotherapy research. •Lead the development and validation of the TME-Chip platform. •Manage project timelines and resources to ensure successful delivery. •Support and communicate with partners to integrate resources and promote R&D progress. •Ensure that R&D complies with relevant laws, regulations and standards. •Prepare investment presentations, represent the company at academic and industry conferences to raise visibility. Qualifications •Ph.D. in Oncology, Immunology, Biomedical Engineering, Pharmacology, or a related field. •Minimum 2 years of experience in biotech or pharmaceutical R&D; prior leadership experience is a plus. •Familiarity with tumor biology, immuno-oncology, organoids, or Organ-on-a-Chip-related technologies. •Experience in cross-functional collaboration and project delivery in dynamic or startup environments. • Strong communication skills in both Mandarin and English; able to represent the company externally.

1. Cell culture 2. Membrane-based and Cell-based functional assays 3. Radio-labeled assays and animal tissue extraction 4. New project or assay development, data analysis, literature review and search 5. Assay troubleshooting, optimization and validation 6. Equipment maintenance and SOP document system management 7. Brainstorming for innovative ideas on new assay method or new testing platform setup 8. Team support and other task assigned by supervisor

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.

細胞株開發是生物製藥產業的核心關鍵，直接影響後續藥物產量、品質與上市時程。本職務將加入我們的研發與開發團隊，負責哺乳動物細胞株（特別是 CHO 細胞）的建立、優化與工程設計，並參與從早期研究到 GMP 技術轉移的重要流程。這是一個能讓你結合專業技術與創新思維，推動新一代生物藥物平台發展的絕佳機會。 1) Cell Line Cultivation and Maintenance Perform hands-on cultivation, passaging, cryopreservation, and recovery of mammalian cell lines (CHO, HEK293, etc.). 2) Cell Line Screening and Workflow Optimization -Design and optimize cell line screening workflows to ensure timely and high-quality project delivery. -Experience with different types of CHO cell lines is welcome; not limited to any specific host type. 3) Cell Engineering and Genetic Modification (Preferred) Experience in CHO engineering is a strong plus, including practical application of CRISPR, transposon, or other genome editing tools for cell line development. 4) Cross-Functional Support and Laboratory Management 5) Assist in laboratory material and reagent management. Provide technical support across different functions and collaborate with R&D and process development teams. 6)Data Analysis and Presentation Effectively analyze experimental results and present findings through reports and presentations, with clear recommendations for improvements.

1. 負責臨床試驗專案的推動、管理、醫學評估，包括IND申請文件準備、試驗執行與GCP查核。 2. 協調內部與委外之工作，維持臨床專案品質並有效掌握專案時程。 3. CRO服務的評估、監督、審核及管理，確保其服務品質與合規性。 4. 藥物臨床試驗之法規遵循。 5. 跨部門相關事務之協助及臨時交辦事項。

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. 市場資訊收集及分析，包含文獻、專利檢索，以支援研發決策。 2. 負責產品測試、品質檢驗、及標準品維護。 3. 制定、更新並執行 QC 標準作業流程（SOP），協助優化品質管理。 4. 配合主管交辦事項，並跨部門協調以確保專案順利推進。 5. 需具備細心、主動回報進度，並展現良好的溝通、協調、解決問題能力。

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

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。

【About the role】 We have an exciting opportunity for motivated individuals to join our CMC team working to develop cell therapies against cancer. The successful candidate will be expected to be a good team player, work with enthusiasm to execute assignments properly. This role is pivotal in translating our cutting-edge research into a robust and scalable manufacturing process, directly impacting our ability to deliver novel therapies to patients. 【Position Title】 Sr. Research Associate / Research Scientist (Process Development) 【Location】 Taipei, Taiwan 【Reports to】 Principal Scientist 【Job Type】 Full-time 【Responsibilities】 • Design and execute experiments for the development, optimization, and scale-up of immune cell manufacturing processes, including cell isolation, expansion, and cryopreservation. • Troubleshoot and resolve process challenges, utilizing a systematic approach (e.g., root cause analysis) to improve process robustness, yield, and consistency. • Evaluate and implement new technologies and equipment (e.g., closed-system bioreactors) to enhance process efficiency and product quality. • Perform cell manufacturing in a cleanroom environment under GTP/GMP guidelines, including meticulous execution of batch records and adherence to stringent aseptic techniques. • Perform in-process controls (IPCs) and product release testing, including cell count, viability, flow cytometry, and other characterization assays. • Author and revise technical documents, including standard operating procedures (SOPs), batch records, and development reports. • Establish the optimized manufacturing processes at the GMP manufacturing site. • Execute and document experiments to support the CMC (Chemistry, Manufacturing, and Controls) section for IND filings. 【Qualification】 • MSc (or above) in life science or related fields (e.g., Immunology, Cell Biology, Bioengineering, Biochemistry). • Minimum of 3 years of hands-on experience in mammalian cell culture with stringent aseptic techniques, preferably with primary human immune cells (e.g., T cells, NK cells). • Hands-on experience with multi-color flow cytometry for immunophenotyping. • Proven ability to work independently in experimental design, execution, and data analysis. • Excellent communication skills and ability to work collaboratively in a team-oriented environment. 【Preferred Qualifications】 • Experience in cell therapy process development, including the use of Design of Experiments (DoE) methodology. • Experience working in a GTP/GMP regulated environment. • Hands-on experience with closed-system cell processing platforms (e.g., CliniMACS, WAVE, bioreactors, cell processing system). • Experience with cell-based functional assays (e.g., cytotoxicity assays, cytokine release assays). • Experience in authoring technical documents such as SOPs or development reports. • Experience with cryopreservation development and optimization.

本職缺為細胞培養助理/副工程師，需求兩位，屬細胞暨分子生化試驗部門，進行無菌細胞培養等實驗室工作，其職務內容如下述，歡迎醫藥/化學/生技相關背景人才加入。 1. 依SOP執行細胞培養、分子生物相關實驗執行； 2. 依SOP執行細胞培養製程開發； 3. 協助撰寫實驗室文件； 4. 協助主管執行專案計畫撰寫； 5. 協同主管執行商務專案洽談； 6. 其他主管交辦事務。

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. Manage the operation of MT and aid physicians in the diagnosis, treatment, and prevention of diseases by testing patient specimens, correlating data, and reporting results in a timely manner to effect quality patient care. Responsibilities: Perform analysis work according to SOPs and guidance. Prepare, review, and approve various documents, including SOPs, protocols, reports, and analytical methods. Manage lab logistics, including purchasing, inventory control, and payment processing. Maintain instruments and ensure cleanliness and maintenance of the workspace. Take on the role of system owner for computerized systems, performing tasks such as validation tests, periodic reviews, and reporting. Attend training courses related to CAP/GCP/GLP/regulatory requirements. Study Based Responsibility (if needed) Analytical Study Director in Study Work as the Study Director, responsible for the overall conduct and final report of the study. Approve the study plan and any amendments by signature, and ensure Quality Assurance personnel receive timely copies. Make study plans, amendments, and SOPs available to study personnel. Ensure procedures in the study plan are followed and document deviations and take corrective action if necessary. Document and record all generated raw data. Validate computerized systems used in the study, sign and date the final report to indicate acceptance of responsibility for data validity, and ensure study materials are archived after completion. Study Personnel in Study Ensure personnel are knowledgeable in relevant Principles of Good Laboratory Practice. Provide study personnel with access to study plans and SOPs applicable to their involvement, with a responsibility to follow instructions and document any deviations. Emphasize the responsibility of all study personnel to promptly and accurately record raw data, comply with Good Laboratory Practice principles, and exercise health precautions to safeguard the integrity of the study.