「Flow Cytometry Research Associate (流式細胞技術部助理研究員)」的相似工作

1.學名藥與新藥臨床一期試驗設計、計畫書撰寫、藥物動力學數據運算、試驗報告撰寫 2.臨床前藥物動力學數據計算與分析，試驗報告撰寫 3.藥物學術文獻彙整評估 4.法規單位函詢與意見回覆 5.台灣/歐美臨床試驗法規 6.一年以上相關工作經驗優先

1.產業導向的嗅覺科學(Olfactory Science) 相關產品研發及企劃工作。 2.嗅覺科學(Olfactory Science)與 Endocrine System, Immune System及Central Nervous System 等相關研究。 。 3. 產品相關資訊調查及收集。 4. 期刊論文撰寫。

CRA for BE study/New drugs/Medical devices 1.Clinical research study setup/study procedure setup/site staff training 2.Site monitoring visits/source data verification/deviation reporting in compliance with GCP 3.Trial documents maintenance/regular site visits and maintenance/study materials supply/interim reports 4.regular report to sponsor/communication between sponsor and site. 5.site close-out/trial materials retrieval 6.audits/regulatory inspection participation upon request

Senior application scientist 一名 Junior application scientist 一名 職務內容: (1)依全球客戶及市場需求，開發微型生物反應器在不同細胞培養技術上的應用及可行性。 (2)能獨立或合作執行多個內部或外部合作研究計劃。 (3)執行細胞培養及細胞分析實驗。 (4)與儀器研發工程端共同合作執行新產品開發的生物分析驗證。 (5)撰寫儀器應用報告及技術報告。 (6)主管交辦事項。 (7)依實驗需求假日輪班。 (8)支援公司展覽。 應徵條件: (1) 需與國外公司開會，必須具備可溝通、良好的英語能力。 (2) 生物醫學相關領域碩士以上學位，具細胞實驗操作經驗。 (3) Senior application scientist需具細胞株開發或細胞治療製程開發相關經驗。 (4) 具獨立思考及解決問題能力。 (5) 樂於合作分享、面對新挑戰及跨領域的協調溝通。 We offer: 。Cutting-edge technology in the fields of microtechnology, automation, software, and biotech. 。A unique opportunity to learn from both our EU and Taiwanese teams. 。Personal development possibilities in a fast-growing and ambitious company 。Competitive salary package. <About you> English language ability is essential. You're expected to communicate with global client fluently about biotech, applications and our products. You are not expected to know everything, but you must be passionate, inspired, and persistent about solving problems and achieving your best. If you are a team player who always goes the extra mile, finds the most efficient solution, takes ownership of your work, and wants to be a part of the most ambitious team in the life sciences, then you might be the one we are looking for!

招募熱忱且細心的研究助理，加入我們的實驗室，支援研究與實驗工作，並協助維持實驗室日常運作。主要工作內容如下： 1. 協助進行科學研究與生物實驗 2. 整理並分析實驗數據 3. 文獻查詢、彙整與報告撰寫 4. 協助實驗室管理與採購 5. 指導學生進行實驗操作 6. 協助撰寫研究計畫與成果報告

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

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. 熟悉人體免疫細胞NK.CIK.DC培養、MSC幹細胞、纖維母細胞培養 2.熟悉flow 設備 3. 製程優化及新產品或技術開發。 .4、配合生產排程，依製程管制標準書及SOP執行符合廠內生產規範之細胞培養製程相關作業 5、GTP/GMP相關之製程設施/設備維護保養 協助儀器設備之確效計畫執行與報告撰寫 6、相關品質文件之撰寫 7、其他支援性工作或主管交辦事項 8、有TAF 17025 完成認證課程尤佳

一、 協助臨床試驗執行 一、 毒理文件管理 1. 試驗文件與工具管理 2. 協助試驗稽核與查核。 3.針對產品毒理找尋文獻及各成分安全性評估。 4.產品系統檢核及資料庫新增。 二、臨床試驗 1. 試驗進度追蹤與管理 2. 執行試驗訪視準備 3. 協助IRB試驗計畫撰寫 三、 受測者團隊溝通 1. 協助執行試驗起始活動 2. 試驗合約與經費協調 四、 其他 1. 標準作業流程遵循、協助修改 2. 協助研發文獻搜尋 3. 協助實驗室或製程發派工作事項 4. 產品試用問卷設計及數據分析。 5. 產品儀器檢測及功效性評估。 6. 研究成分、撰寫產品說明書。 7. 研究化妝品成分及法規及相關文獻資料。 8. 對臨床實驗檢測有經驗者尤佳。

1. 執行臨床試驗相關業務，包含試驗前準備、臨床收案、受試者追蹤，及試驗資料管理等； 2. 協助研究倫理委員會送審、管理臨床研究資料； 3. 協助計畫相關行政作業，例如計畫審查作業等； 4. 其他研究主持人交代事宜。

【工作內容】 具醫檢師執照佳 1.分子生物技術及實驗 2.基因檢測服務 3.NIPT或NGS相關檢測服務 4.實驗室行政事務 5.品質系統維護

1. 進行細胞培養、建立相關技術、細胞製程優化(有相關經驗者佳)。 2. 協助對岸實驗室運作。 3. 資料搜索、整理，文獻探討。 4. 協助建立、管理、遵從品質四階文件。 5. 其他主管交辦事項

1. 協助臨床試驗檔案製作與TMF管理 2. 協助臨床試驗相關資料整理歸檔(檔案室管理) 3. 協助準備試驗文件及相關耗材管理 4. 協助處理行政事務(安排會議、文具訂購、部門報帳等相關事宜) 5. 主管交辦事項

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. A successful candidate will be expected to have a solid background in cell biology, immunology, immune cell differentiation and expansion processes, scale-up, experience working in or supporting a cGMP-regulated environment, as well as sound technical knowledge of manufacturing processes for engineered immune cell therapies. ROLE OVERVIEW You will have high internal visibility focusing on developing robust and scalable manufacturing platforms for allogeneic cell expansion and directed differentiation. You will have the opportunity to establish manufacturing platforms and guide product development through all stages of development to ensure project advancement. This role will work with analytical development and R&D team to understand and identify the general function, activity, characteristics, purity, stability, and safety of cell products. The role will identify the manufacturing flow and key process parameters and execute clinical manufacturing activities to provide the required information in IND package. He/She will utilize their technical expertise to ensure data is accurate and high quality under the GMP guiding principle. RESPONSIBILITYIES 1. Design and execute phase-appropriate process development studies identifying process parameters and appropriate ranges to be assessed for optimal experimental design of the study 2. Design and execute DP process-enabling studies including formulation, fill/finish, cryopreservation, thawing, and in-use compatibility study of candidate cell therapy product. 3. Testing new manufacturing technologies and platforms in partnership with R&D. 4. Develop robust, scalable, directed-differentiation processes platform. 5. Be responsible for preparation of protocols, reports, test methods, and SOPs. 6. Review and discuss analytical results and conclusions both orally and in writing. 7. Work in a team-based structure and interface with research and process development departments. 8. Maintain and ensure safe laboratory environment and work practices. 9. Ensure timely completion of testing and tasks as assigned. QUALIFICATIONS AND REQUIREMENTS 1. Master with 3+ yrs. or 6+ yrs. of relevant experience in industry with a focus on in immune l culture, differentiation, expansion, formulation process. 2. Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes is required. 3. Hands-on experience with common cell therapy laboratory equipment and technology platforms (i.e. primary NK cells, iPSC-derived cell types, etc.) 4. Experience with cell culture bioreactor operations and process scale up with application to cell therapy is required. 5. Familiarity with flow cytometry assays and other cell-based characterization assays (i.e. cytokine release and cytolytic assays) is a plus. 6. Deep understanding of biologics industry process development strategies and best practices as applied from early development. 7. Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic. 8. Excellent presentation skills, written and verbal. 9. Occasional weekend work may be required. 10. Understanding of GMP regulations is preferred. BEIGENE GLOBAL COMPETENCIES When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

ICON公司為全球前五大CRO 臨床試驗機構，全球第一大FSP公司，與全球頂尖的藥廠合作，提供專業的臨床研究服務。 提供員工良好且完整的教育訓練，透明的升遷制度，完善的休假制度，周休二日，讓員工能在良好的支援下為世界提供更新、更好的新藥品。 臨床試驗專員 1.藥品臨床試驗計畫啟動至結案過程的觀測及監督。 須具備良好的溝通能力以及敏捷的緊急應變能力，能跟試驗單位進行良好的溝通，並協助案件進行。 2.臨床試驗相關個案報告整理。須具備良好的檔案管理能力。 3.工作型態：需要出差到試驗單位(醫院)，查看臨床試驗的進度，並定期回報給專案經理，確認試驗持續符合計畫案的里程碑。出差天數依據試驗案的進程而定。 4.具備良好的英文讀寫能力，所有公司文件皆以英文撰寫。 5.目前需要具備一年以上的臨床試驗案進行經驗的人才。職級及薪水的核定將以面試來決定。面試有兩關，約在兩周內就會完成。 6. 歡迎持有身心障礙證件者投遞 Responsibilities The Clinical Research Associate is ultimately responsible for the successful management of investigator sites throughout the trial lifecycle. Key responsibilities include: 1. Full ownership of investigator sites for assigned studies with responsibility for the successful management of the site right through to close-out. 2. Planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan. 3. Develop effective relationships with investigator site staff to ensure that key clinical metrics are met. 4. Preparing for and attending investigator meetings, coordinating the timely shipment and the subsequent proper storage and accountability of clinical supplies, and following up on drug safety issues. 5. Ensuring the integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines 6. Negotiation and ongoing management of clinical trial agreements with investigative sites.

1.分子生物領域研究及實驗。 2.實驗室日常管理。 3.研究與實驗分析。 4.新市場趨勢收集。 5.其他主管交辦事項。 本職位是公司研發團隊中非常重要的一員，有著良好的發展前景。我們正在尋找有才華的人才，與我們共同推進公司的研發。 如果您滿足以上要求，並對我們公司的研發事業感興趣，請盡快申請本職位。

我們是智新生技，專注於新藥開發與 GMP 製造，現正尋找對「微生物分析與環境監控」有熱情的你，一起打造高標準、符合法規的製藥品質實驗室！ ｜職務說明｜ · 執行微生物分析方法之開發與確認作業 · 建立與維護 GMP 微生物實驗室相關標準作業程序（SOP） · 進行潔淨室環境監控 · 執行一般日常檢驗作業 · 管理與維護微生物實驗室使用之相關設備 · 辦理藥品微生物檢驗及試劑管理作業 · 執行微生物實驗室檢驗設備之維護、校正與操作 · 配合完成其他主管交辦事項 ｜Job Description｜ · Development and validation of microbiological analysis methods · Eestablishments and maintenance of SOPs related to GMP microbiological laboratories · Clean room environment monitoring · General daily experiment · Management and maintenance of equipment used in microbiology laboratories · Pharmaceutical microbiological testing and reagent management · Maintenance, calibration and operation of microbiological laboratory testing equipment · Other matters assigned by the supervisor

【工作說明】 1. 影像技術應用：開發與應用先進影像技術（如光學顯微鏡、共聚焦顯微鏡）以觀察細胞結構和功能。 2. 數據處理與分析：運用影像處理與數據分析工具提取細胞影像中的有用資訊。 3. 跨領域合作：與生物學家及醫學研究人員合作，提供影像數據分析支持。 4. 軟硬體開發：設計並開發專用的影像處理軟體與硬體設備。 5. 技術創新：探索並應用新技術，如人工智慧與機器學習，提升影像分析精度。 【加分技能】 熟悉影像處理軟體（如 ImageJ、Fiji、MATLAB、Python 等）及相關技術，用於分析細胞影像。 熟悉各種顯微鏡技術（如光學顯微鏡、共聚焦顯微鏡、超分辨率顯微鏡等），並能操作、維護這些設備。 具備程式設計能力（如 Python、MATLAB）來開發自動化處理和數據分析工具。

如果你是一位擁有醫檢師執照的專業人才，如果你對臨床試驗的檢驗分析有高度熱情，如果你渴望挑戰自我，我們需要你！ 我們正在尋找一位積極、具有創造力並對於檢驗分析充滿熱情的醫事檢驗師加入我們的團隊。作為我們的醫事檢驗師，你將可以在醫事檢驗所執業登記，並參與到檢驗前、中、後的活動。除了提供良好的工作環境並有免費的零食餵食以外，還有完善的教育訓練制度，我們同時擁有一個已有20多年美國病理學會(CAP)認證歷史的醫學實驗室，並致力於不斷提升自我，為臨床試驗中的受試者提供最好的檢驗服務。 如果你擁有生化、免液、血液與尿液、凝固學至少2項（如有分生plus），至少一年醫檢師的工作經驗，並在流式細胞儀分析、分子生物、病理檢驗染色、手工血清學有檢測或是方法開發經驗，那麼這是一個絕佳的機會，請盡快加入我們的團隊。同時，如果你擁有ISO-15189受訓證書或是有至少參加過一次CAP inspection的經驗，更是加分。 此外，我們歡迎積極、樂觀、勇於接受挑戰的個性的人加入我們的團隊。如果你渴望或是尋求機會可以跨足生技產業的行業展現自我，希望通過不斷學習和提高提升自我，那麼這將是一個絕佳的工作機會。如果你想脫離單調的醫院工作環境，請加入我們的團隊，開始一段全新的職業生涯。放下手中的鍵盤在靠北醫檢師社團的抱怨，期待你的加入！ If you are a licensed medical technologist with a passion for clinical trial testing and a desire to challenge yourself, we need you! We are looking for a proactive, creative and passionate medical technologist to join our team. As our medical technologist, you will be able to register for practice in the medical laboratory and participate in pre-analytical, analytical, and post-analytical activities. In addition to providing a good working environment and free snacks, we have a well-established educational training system and a clinical laboratory that has been certified by the College of American Pathologists (CAP) for more than 20 years. We are committed to continuous improvement and providing the best testing services for clinical trial subjects. If you have more than two years of medical technologist experience and have method development or analysis experience in flow cytometry analysis, molecular biology, pathology staining, and manual serology testing, this is an excellent opportunity to join our team. Furthermore, if you have an ISO-15189 training certificate or have participated in at least one CAP inspection, that's a plus. In addition, we welcome individuals with positive, optimistic, and challenge-accepting personalities to join our team. If you are eager or seeking opportunities to step into the biotech industry and show your talents through continuous learning and improvement, then this will be an excellent job opportunity. If you want to break away from the monotony of hospital work environments, join our team and start a new career.

1.實驗動物照護 2.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、靜脈插管、組織處理等技術 3.規劃、設計、執行前臨床試驗，分析結果及撰寫報告 4.具有統計分析能力 5.其它主管交辦事宜