「[台北總公司] 細胞製程/研發工程師」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

【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》

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. GTP實驗室幹細胞及免疫細胞製程生產。 2. GTP品質系縭相關作業執行。 3. 標準作業流程SOP之擬訂和修改。 4. 相關文獻整理。 5. 製程開發改進等研發工作、科專計畫、特管法和臨床試驗計畫編修撰寫。 6. 其它主管交辦任務。 7. 需配合週末輪班。 8. 實驗室庶務及管理，包含但不限於儀器設備維護、物料採購等。 以上工作內容將依公司人力需求及個人工作狀況調整。

1. 細胞治療技術研發與生產團隊之營運管理，確保製程研發、品管、GMP 生產之品質，符合客戶與法規需求 2. 與國內、國外細胞與基因治療公司，建議良好的溝通管道與信任關係 3. 細胞治療製程開發實驗室之管理與營運，確保研發與檢測品質 4. 細胞治療產品 GMP工廠生產製造管理，確保細胞產品生產符合法規與臨床要求 5. 客戶拜訪、接洽，並完成服務案件之簽約。進度與交付事項管理，確保依規劃允收完成 6. 與醫學中心建立合作關係，維持良好的組織來源管道，以建置 TBMC 高品質組織細胞來源與細胞生產種源原料庫建置 7. 持續規劃技術研發，以降低細胞產品成本。例如: 自動化生產的導入，提升生產效率並降低人力成本

1. 抗體藥發現工作規劃、執行、與管理，具嚴謹邏輯與風險管控思考能力。 2. 分子細胞學分析實驗設計，建立與執行。 3. 抗體新藥發現、CMC\臨床開發或市場調查等工作，且具經驗者佳。 4. 需能快速查詢且閱讀國內外文獻，彙整思考後提出簡報，以解決目前面臨問題。 5. 其他主管交辦事項。

【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！

Job Summary： As a member of Central lab team, you will be supporting the start-up of a cell-based assay and flow cytometry analysis. You will help define the requirements for validation and will establish processes under line manager's supervision that will enable the Central lab to operate successfully with regard to the analysis and characterization of cell-based therapies or vaccines; specifically as a flow cytometry scientist. This role provides the opportunity to closely partner with the vaccine development and clinical trials as you define and execute the start-up activities associated with establishing flow cytometry / cell-based assay capabilities and expertise at Central lab. Responsibilities include flow cytometry / cell-based assay method development, validation, qualification, transfer and troubleshooting. In addition, the candidate will be expected to write the validation / analytical protocol and report. Additional responsibilities include validation of computer systems, and management/administration of equipment (e.g. instrument, etc.). General Responsibilities: 1.Collaborate with external groups to identify technology and business processes that will establish flow cytometry / cell-based assay expertise at Central lab. 2.Conduct analysis work following related SOPs and guidance. 3.Review data and evaluate against established acceptance criteria 4.Define requirements for laboratory equipment and support purchasing. 5.Evaluate data to identify trends and/or establish limits 6.Participant in discrepancy investigations and corrective actions 7.Receive and provide training 8.Lead assay development, transfer and validation activities 9.Write, review or approve equipment qualification/maintenance life cycle documents 10.Draft, check, review or approve documents, such as SOP, protocol, analytical result, report and method. 11.Write protocols and reports under limited supervision 12.Assure and apply GCP/CAP throughout operations 13.Participate in CAP/GCP/GLP/ regulatory related training courses. 14.Support internal, external, and regulatory inspections 15.Work to meet schedules, timelines, deadlines 16.Participate in and/or lead projects and process improvements 17.Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc. 18.Provide input or set personal performance goals and departmental objectives Establish work priorities to meet targets and timelines; manage competing priorities Other tasks assigned by line manager. Clinical Lab Service Scientist 1.Participate in and/or lead projects and process improvements Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc. 2.Provide input or set personal performance goals and departmental objectives Establish work priorities to meet targets and timelines; 3.Manage competing priorities Other tasks assigned by line manager.

1.原料秤取 2.培養基/配製緩衝液配製 3.廠區環境消毒維護 4.製程器具清潔/包裝滅菌 5.台中/竹北GMP文件撰寫與改版 6.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。

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。

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。

We are seeking a highly skilled Website & Digital Content Specialist to join our pharmaceutical company in Taiwan. This role will be responsible for managing, updating, and optimizing our global website content, ensuring accuracy, compliance, and timely execution of updates. The ideal candidate will have strong experience in biopharma or life sciences content management, excellent English proficiency, and the ability to serve as a key liaison with cross-functional teams, including our U.S. headquarters, medical/legal/regulatory (MLR) review boards, and brand planning committees. This position goes beyond execution: the selected candidate will also contribute strategic insights on how to improve website engagement, align digital content with brand strategy, and enhance our global online presence. <Key Responsibilities> 1.Website Content Management • Own the process of updating and maintaining company website content (corporate, product, medical education, and brand-related pages). • Ensure scientific and medical accuracy of all published content, with special attention to regulatory compliance. • Coordinate urgent or time-sensitive content updates, ensuring flawless execution under tight timelines. 2.Cross-Functional Collaboration • Act as the key owner and liaison for Medical-Legal-Regulatory (MLR) review processes, ensuring all digital content passes required approvals. • Work closely with U.S. and Asia-based teams, bridging time zones and cultural contexts to ensure seamless communication. • Participate in brand planning discussions, contributing recommendations on content strategy and alignment with brand goals. 3. Digital Strategy & Social Media • Support and enhance the company’s digital presence across owned media (website, social media, corporate communications). • Leverage social media management experience to recommend content strategies and community engagement initiatives. • Monitor digital content performance and propose optimization opportunities.

*前1~3年工作在「台中廠」培訓，之後開始在「竹北廠」上班。 ●原物料、IPC、產品、安定性樣品、水質之內毒素分析 ●生物活性試驗Bioassay、host cell DNA、host cell protein、sterility等項目例行檢測 (放行檢測、安定性檢測) ●異常事件調查 ●設備維護及校驗執行 ●分析方法SOP制定 ●實驗室LIMS系統 ●其他主管交辦事項

公司細胞產品製程專案執行 1.免疫細胞/幹細胞製程專案執行 2.製程物料採購、管理 3.文獻閱讀整理 4.製程優化及新產品或技術開發 5.實驗室品質文件優化撰寫 6.實驗室庶務 7.主管交辦事項

1. 依品質系統與標準作業流程執行臨床檢體檢測，並確實記錄檢測流程參數及數據 2. 按時程完成數據分析和出具檢測報告 3. 依需求建立新的檢測程序與檢測方法確效或優化現有的檢測方法 4. 需撰寫技術類程序書與標準書，並定期審視現有版本及優化改版 5. 其他主管交辦事項。

執行公司內部臨床試驗，您將作為 PMS (project management specialist)，根據專案的時程接觸到 CTA/SSU/CRA/RA相關事務 1. 管理及協調CRO、SMO、中央實驗室及研發團隊，特別針對細胞治療專案，追蹤試驗進度與技術需求，並必要時更新實驗室手冊，確保符合GTP及相關品質標準。 2. 負責臨床試驗計畫書變更之FDA及IRB送審，供應商合約簽署與費用管理。 3. 確保試驗藥品及細胞治療產品的供應與使用，必要時更新藥品手冊，並協助監控細胞治療產品的製備、運送及品質控管。 4. 追蹤試驗偏差與不良事件（AE/SAE），協助制定及執行矯正與預防措施（CAPA）。 5. 整理試驗資料與品質控管，確保數據完整並符合GCP、GTP及法規要求。 6. 與跨部門及試驗中心保持良好溝通協調，支持專案管理及問題解決，並配合細胞治療專案的特殊合規要求。

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. 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。

Job Summary As a member of the Central Lab team, you will be primarily responsible for the development, optimization, validation, and testing of Potency Assays based on cellular and immunological principles, as well as ELISA, cell culture, and functional assays. You will help define validation requirements and establish compliant processes under the supervision of the line manager, enabling the Central Lab to successfully develop, validate, and deliver high-quality assays to support clinical trials and regulatory submissions. This role also offers the opportunity to closely collaborate with clinical trial teams as you define and execute the start-up activities required to establish these assay capabilities and technical expertise within the Central Lab. You will lead or contribute to method development, optimization, validation, and transfer of assays, including cell-based functional assays, ELISA, and other immunoassays, while ensuring full GLP compliance. The role involves performing mammalian cell culture, advanced analytical techniques (e.g., Flow Cytometry, qPCR/dPCR), and driving method transfer and validation from external partners. Additionally, you will be responsible for supporting computer system validation, ensuring data integrity, audit readiness, and regulatory compliance across lab operations. General Responsibilities: 1. Collaborate with external groups to identify technology, method evaluation and business processes that will establish potency assay expertise at Central lab. 2. Conduct analytical testing in compliance with established SOPs and relevant guidance. 3. Review data and evaluate against established acceptance criteria. 4. Define requirements for laboratory equipment and support purchasing. 5. Evaluate data to identify trends and/or establish limits. 6. Participant in discrepancy investigations and corrective actions. 7. Provide training to department team member, especially in potency assay techniques. 8. Lead assay development, optimization, transfer and validation activities. 9. Write, review or approve equipment qualification/maintenance life cycle documents. 10.Draft, check, review documents, such as SOP, protocol, analytical result, report and method under limited supervision. 11.Support internal, external, and regulatory inspections. 12.Other tasks assigned by line manager. Qualifications: Education and Experience: 1. Master’s degree in Biotechnology, Biochemistry, Pharmaceutical Sciences, Laboratory Science, or related field. 2. 3+ years of experience in potency assay, ELISA, and/or cell-based assay development, preferably from CDMO, CMO, CRO, or GMP-regulated laboratories. 3. Familiarity with assay development for vaccines, biologics, ADC, or cell therapies is a plus. 4. With direct experience in flow cytometry method development is preferred. 5. Demonstrated ability to apply knowledge of potency assay theories, principles, and techniques. 6. Medical technologist license is a plus, but not required. Skills and Competencies:  Strong expertise in assay validation, method lifecycle management, and data analysis.  Familiarity with clinical trial lab operations and regulatory compliance.  Excellent documentation skills for regulated environments.  Effective communication and collaboration with cross-functional teams and clients.  Strong troubleshooting and problem-solving abilities.  Good verbal and written communication in English.  Ability to manage multiple priorities and meet deadlines in a dynamic CRO setting.