「醫材研發專案人員」的相似工作

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

1. 產品劑型開發 2. 產品製備與試驗 3. 支援分析與資料整理 4. 其他主管交辦事項

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.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. 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. 負責ADC藥物製程開發及純化 2. 有機合成實驗操作、化合物純化及鑑定 3. 執行固相合成實驗及製程開發 4. 具備光譜分析和文獻查詢能力 5. 協助實驗室事務

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. 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。

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

我們正在尋找一位對醫療器材研發充滿熱情的工程師，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! 工作內容 • 負責醫療器材的設計、開發與改進。 • 與跨部門團隊合作，確保產品符合法規與市場需求。 • 執行產品測試、性能評估與品質控制。 • 分析與解決技術問題，提供創新解決方案。 • 撰寫技術文件與專案報告。 資格條件 • 學歷：生物、材料、生物醫學工程相關科系畢業，碩士學歷尤佳。 • 經驗：3年以上醫療器材研發經驗，熟悉相關技術與法規。 • 技能：具備生材料分析或高分子合成經驗尤佳。 • 語言能力：良好的中英文溝通能力（需撰寫技術文件）。 特質 o 主動積極、能快速理解專案需求。 o 優秀的問題解決能力與團隊合作能力。 o 細心且具備責任感，能在壓力下完成任務。 我們提供 • 具有競爭力的薪資與福利方案。 • 彈性工作時間與友善工作環境。 • 持續學習與成長的機會（專業培訓、國際會議等）。 • 參與創新技術開發，為全球醫療領域帶來貢獻。

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

【關於我們】 陽光燦亮診所是一家前瞻醫美中心，同步投資自有生技實驗平台，專注於高分子與天然衍生新材料的開發與轉譯。我們相信，最尖端的醫美成果來自「專業醫學 × 研發實力」零距離的不斷迭代推陳出新。 【為什麼加入我們】 1. 直觀見證成果-新材料從概念到臨床應用的週期大幅縮短，研發成果能快速在醫美產業創造價值。 2. 跨域學習資源-與皮膚科、整形外科醫師及生醫材料、組織工程專家協作，掌握市場第一手趨勢。 3. 完整研發鏈-內建細胞／組織培養室、材料分析儀與 GLP 級測試流程（規劃中），並同步專利佈局、學術發表與臨床試驗。 想把前沿生技材料化為可實踐、具體的醫美價值？ 這裡就是能讓你看見影響力的舞台。 【職務內容】 1. 生物技術的評估、測試、分析與選擇 2. 醫療器材及其製造技術的評估、測試、分析與選擇 3. 既有產品或技術的優化與製程導入 4. 細胞與動物實驗驗證 5. 制訂產品檢驗標準 6. 其他主管交辦事項 一起開發下一代醫美材料，創造真正改變肌膚與自信的解決方案。 立即投遞履歷，和陽光燦亮診所共創未來！

【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.

案件之研發（包含處方開發、試製、設備安裝清洗、溶離試驗執行及數據處理） 內部會議之準備及報告（含進度會議及文獻資料報告） 協助實驗室維護相關事項 工廠生產相關文件撰寫及聯繫 查驗登記相關文件撰寫 ※ 可接受關係企業調動

Please do submit English resume to our company website. https://fa-euzi-saasfaprod1.fa.ocs.oraclecloud.com:443/hcmUI/CandidateExperience/en/job/1488?utm_medium=jobboard General Responsibilities: Manage staff in accordance with organization's policies and applicable regulations, including without limitation: planning, assigning, and directing work; managing performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; acting as a coach and mentor for subordinates as they develop in their role. Participate in the selection and onboarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs. Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable. Maintain lab daily operation. Ensure the quality and timely of lab deliverable. Perform the tasks assigned by line manager. Refer to additional GLP/GCP Regulation Required Responsibilities while involved in GLP organization. As the member of test facility/site management. Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc. GLP/GCP Regulations Required Responsibilities (if needed): Lab Manager Maintain an internal responsibility chart which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by the Principles of Good Laboratory Practice. Ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study. Ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual. Ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions. Ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the Study Director before the study is initiated. Replacement of a Study Director should be done according to established procedures, and should be documented. Ensure, in the event of a multi-site study, that, if needed, a Principal Investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a Principal Investigator should be done according to established procedures, and should be documented. Ensure documented approval of the study plan by the Study Director. Ensure that the Study Director has made the approved study plan available to the Quality Assurance personnel. Ensure the maintenance of a master schedule. Ensure that test facility supplies meet requirements appropriate to their use in a study. Ensure for a multi-site study that clear lines of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel. Ensure that test and reference items are appropriately characterized. Ensure that appropriate and technically valid Standard Operating Procedures are established and followed, and approve all original and revised Standard Operating Procedures. If necessary, function as Study Director for specific study, in this case, he/she must not have the responsibility of test facility/site management role in the study.

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. 基因檢測產品開發。 2. 期刊文獻收集閱讀。 3. 分析次世代定序實驗數據。 4. 執行次世代定序實驗與導入新興技術與應用。 5. 主管交辦事項。 【加分(薪)項目】 1. 具認證實驗室工作經驗，如 CAP、TAF/ISO15189醫學實驗室、或TFDA/LDTS實驗室。 2. 具次世代定序操作(Illumina、MGI、Ion Torrent)與應用經驗(WES、RNAseq等)。 3. 熟悉相關周邊儀器原理及使用(qPCR/BioAnalyzer/Fragment Analyzer/Qubit等。 4. 依據學歷及經歷調整薪資及助理研究員、副研究員或研究員職缺。

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。

- 負責產品取證與國際法規申請（TFDA、FDA、CE） - 協助撰寫醫療軟體/AI產品相關法規文件 - 協助追蹤各國醫療法規與送審資料準備 - Handle certifications (TFDA, FDA, CE, etc.) - Prepare regulatory documentation for software/AI medical devices - Track global regulations and support submission

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。