「研發人員」的相似工作

1. 獨立執行動物實驗： (1) 熟悉大鼠、小鼠之動物照護 (2) 採血：心臟採血、尾靜脈採血、臉頰採血 (3) 皮下注射、腹腔注射、皮內注射等技術熟練 (4) 小動物麻醉 (氣體麻醉) (5) 能夠辨認大鼠、小鼠臟器，並且熟悉解剖流程 (解剖經驗需要以全臟器為主) 2. 組織萃取與檢體處理 3. 實驗結果整理與實驗紀錄報告撰寫

1. 新穎次世代大分子藥物之分析方法開發與執行 (Potency, ELISA, HPLC 等等)。 2. 分析方法SOP建立、方法驗證/確效、計劃書與報告撰寫。 3. CMC 文件撰寫。 4. 試驗專案設計與管理 。

1. 中西藥交互作用研究 (包括：重組蛋白、細胞、動物實驗)。 2. 處理文書業務及其他交辦之行政與研究相關事項。 雇用期限：114年10月1日至115年12月31日止

1. 執行臨床前動物試驗和臨床試驗相關檢體分析 2. 操作HPLC、LC-MS/MS、ICP-MS等化學分析儀器 3. 參與GLP相關試驗，依循計畫書與SOPs操作及執行研究;數據整理、研究紀錄彙整與報告撰寫 4. 參與技術方法開發和方法確效 5. 擔任儀器或實驗室事務管理人

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。

【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.

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。

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.​執行及管理​新藥研發所需之動物實驗，探討藥物療效, 藥物動力學及藥物安全性等。 2.規劃並執行專案所需之免疫組織染色, 判讀並彙整結果，探討藥物作用機轉及適應症評估等。 3.依專案需求進行文獻搜尋、計畫評估、實驗設計及執行新藥研發專案所需之相關工作。​

1. 執行 CAR-T 及其他細胞治療產品之製程品質檢測，確保產品品質與臨床使用安全性。 2. 負責臨床檢體之檢測、數據分析與結果解讀，支持臨床試驗與研發計畫。 3. 建立並優化符合 GxP 規範之分析方法，並執行方法確效與驗證。 4. 撰寫並維護相關分析方法、確效與驗證之技術文件及報告。 5. 進行實驗儀器日常維護、校正與紀錄，確保檢測準確性與實驗室合規。 6. 協助品質體系之持續改進與合規運作。 7. 完成主管交辦之其他專案與任務。

1. 獨立作業而且能掌握研發專案的時程及成果交付。 2. 具管理內部資源之能力，控制部門/或專案活動之預算。 3. 臨床試驗文件撰寫和/或審閱。 4. 評估專案相關議題並研擬解決方案，與專案主管、團隊及外部合作者、委外供應者進行協調溝通。 5. 委外研究、CRO之評估、執行追蹤及品質管理。 6. 各國IND申請及臨床驗證之規劃及執行。 7. 具供應商管理經驗。 8. 具有CRA經驗尤佳。

1. 臨床試驗管理：負責臨床試驗專案之推動(IND申請文件準備、試驗執行與GCP查核)、管理、醫學評估與確保臨床試驗符合法規要求 2. 專案協調與時程控管 3. CRO管理：服務的評估、監督及審核CRO，確保其服務品質與法規合規性 4. 實驗操作與數據分析：熟悉細胞與分子生物學實驗、探索小分子藥物在脂肪酸合成、發炎與纖維化路徑之機轉，撰寫報告並解釋結果、解決問題 5. 具大小鼠動物實驗佳 6. 良好論文檢索能力 7. 抗壓性強，具獨立作業能力

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. 開發學名藥或新藥的口服固體製劑或者注射製劑之配方。負責指定產品的配方及其製程開發項目。 2. 彙整基本口服固體製劑和注射製劑相關法規 (包括並不限於各國藥典，ICH guideline等)，設計並訂定原料、半成品和成品的規格及化驗SOP。 3. 基本層析(Chromatography)項目的分析方法開發、化驗執行和確效工作 (例如HPLC、GC等)。

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. 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. 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

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。

依據團隊規劃之研發專案方向執行以下工作: 1. 新產品規劃與探索 2. 新產品開發專案管理與執行 3. 細胞/生化實驗設計與執行 4. 動物試驗方法開發與討論 5. 專利答辯及回覆方案建議 6. 協助產品申請之生物藥理技術回覆與方案建議 條件: 1. 相關科系博士畢，或具備7年以上相關工作經驗 2. 具備實驗設計、規劃及執行能力 3. 擁有豐富的細胞培養經驗與知識 4. 執行分子生物學（q-RT-PCR、RNA seq、ELISA 或 WB）的經驗 5. 有免疫染色（流式細胞儀、IHC或IF）相關經驗

Cosmetic Research Chemist - Personal Care Formulation Key Responsibilities: •Project Management: Independently manage projects and assignments from inception to completion. Utilize excellent time management and prioritization skills to handle multiple projects and meet deadlines efficiently. •Analytical Procedure Development: Lead and support the design and execution of analytical methods for evaluating active ingredients and formulation excipients across personal care products. •Method Development & Validation: Develop, validate, and optimize analytical methods to collect, interpret, and report essential data that drives product development and ensures compliance with global regulatory standards. •Process Improvement: Compile and analyze test results to recommend and implement improvements in formulation development, from lab to production. Adjust batches and validate specifications as necessary. •Data Analysis & Reporting: Accurately collect, process, and interpret data, drawing scientifically sound conclusions. Prepare comprehensive reports and submissions based on weekly schedules to convey findings to both technical and non-technical stakeholders. •Product Stability & Troubleshooting: Ensure product stability throughout the development process, troubleshoot issues as they arise, and oversee the formulation's transition from lab scale to production, including supervising pilot and initial production batches. •Documentation & Compliance: Maintain accurate real-time entries in lab notebooks, issue ingredient listings and product specifications, and create/update SOPs as they relate to Research and Development. Adhere strictly to GMP and SOP standards, ensuring high quality, compliance, and safety. •Innovation & Technology Utilization: Integrate existing and new analytical technologies into development programs to foster innovation within the analytical chemistry community. •Training & Mentoring: Assist in training and mentoring junior chemists to promote professional growth and advancement within the team. •Cross-Functional Collaboration: Work closely with sales, marketing, regulatory, operations, and manufacturing teams to understand business objectives and provide technical support throughout the product lifecycle, including pre- and post-market phases. •Instrumentation & Housekeeping: Perform general troubleshooting and maintenance of lab equipment, calibrate R&D lab equipment as needed, and maintain a clean and organized lab environment. •Industry Awareness & Professional Development: Stay informed of consumer trends, advancements in analytical chemistry, and participate in cosmetic seminars and meetings to enhance product development efforts. •Flexibility & Additional Duties: Be flexible and willing to perform additional duties as needed, such as filling lab batches into components, preparing evaluation sheets and labels, assisting in company audits, and other tasks as instructed by R&D Management. •Regulatory Communication: Effectively communicate project statuses through technical reports, presentations, and regulatory submissions.