「R&D: (Associate) Director of ADC 研發: (助理)總監 (ADC)」的相似工作

• 參與ADC(Antibody Drug Conjugate)藥物研發，開發並優化偶聯技術(Conjugation Technology)。 • 建立多元化的偶聯平台。 • 負責早期抗體偶聯藥物的偶聯與純化方案規劃與執行。 • 負責抗體偶聯藥物的相關製程開發，進行跨部門合作。 • 負責偶聯樣品純化與質量分析（UV, HPLC, LC-MS）等工作。 • 配合專案執行, 確保偶聯實驗銜接上下游物流，及實驗室管理和儀器設備維護保養，管控物料庫存量等，不拖延專案時程，按時交付偶聯產品。 • 專利文獻技術分析、持續掌握偶聯技術和ADC開發的最新趨勢，定期分享該領域相關期刊。

【About the role】 You will support the execution of Acepodia’s intellectual property (IP) operations by ensuring that all patent-related activities are strategically aligned with the company’s R&D roadmap and business objectives. In this role, you will work closely with the IP lead, R&D teams, and external patent counsel to translate scientific advancements into timely, high-quality IP actions. Your contribution will help strengthen the protection of Acepodia’s innovations and support the company’s long-term value creation. Your core responsibilities include organizing technical documentation throughout the patent prosecution process, monitoring competitors’ patent activities, and assisting with freedom-to-operate (FTO) analyses to support research and business strategies. You will also help facilitate communication between scientific teams and legal advisors, ensuring that our IP coverage evolves in parallel with R&D progress across both cell-based and non-cell-based pipelines. We seek a candidate with a background in chemistry, biology, or a related field, along with proven experience in patent prosecution or IP operations. The ideal candidate is detail-oriented, well-organized, and motivated to deepen their understanding of IP work in a dynamic biotech environment. 【Position Title】 (Senior) Patent engineer 【Location】 Taipei, Taiwan. 【Reports to】 Associate Director of Patent 【Job Type】 Full-time 【Education /Background】 • A Master's degree or above in biotechnology, pharmacology, chemistry, cell or molecular biology, bioengineering, or a related field, with a solid technical background in biotechnology, molecular biology, chemistry, biochemistry, and/or pharmacology. • Experience in patent or law firms with prior art searches, patent applications drafting, and legal or office action responses; and/or in biotech-related companies conducting freedom to operate (FTO) analyses. 【Responsibilities include but are not limited to】 • Support the implementation and execution of Acepodia’s patent portfolio management in alignment with the company’s R&D roadmap and business priorities. • Coordinate with R&D teams and external patent counsel to ensure timely and accurate handling of patent filings, responses, and other prosecution matters. • Assist in drafting technical descriptions and patent specifications, and support the preparation of response materials during prosecution. • Conduct internal patent searches and assist in freedom-to-operate (FTO) assessments, helping identify potential IP risks or opportunities. • Perform other IP-related assignments and responsibilities as delegated by the IP lead. 【Position Requirements & Relevant Skills & Experience】 • At least three years of experience in patent or law firms and/or in biotech-related companies. • MSc degree or above in biotechnology, pharmacology, chemistry, cell or molecular biology, bioengineering, biochemistry, or a related field. • Strong communication skills, both written and verbal. • Excellent analytical skills with strong attention to detail and problem-solving ability. • Must have proficiency in English.

1. 根據製程管制標準書及 SOP 執行符合廠內生產規範之細胞培營製程作業、批次生產記錄撰寫、相關資料分析整理、其他相關報告及文件撰寫 2. GTP/GMP 相關之標準作業流程 SOP 之擬訂及維護、相關品質文件之撰寫 3. GTP/GMP 相關之儀器設備之確效計畫執行與報告撰寫 4. GTP/GMP 相關之製程設施/設備維護保養 5. 生產製程開發/優化工作、計畫和報告撰寫 6. 實驗室庶務及管理 , 包含但不限於儀器設備維護、物料採購、倉儲管理 等 7. 其他支援性工作或主管交辦事項 。

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. 蛋白生產相關檢測與定量方法開發與優化 2. 協助分析方法的驗證與確效 3. 維護並管理分析實驗室相關儀器 4. 完成其他主管交辦事項

1. 支援新生物藥與 ADC 專案早期開發相關分析工作，除一般通用分析 (e.g. PAGE, SE-HPLC, RP-HPLC, Intact mass, IEF...)，亦協同支援劑型開發與產品安定性分析。 2. 協助產品基本特性分析 (例如: cIEF, DAR, DSC, DSF, glycan, qCD…)，與相關結構分析工作，以確認蛋白組成、協助改善製程與品質。 3. 協助維護ADC lab 運作，例如實驗室環境監控、儀器確效與相關文件維持。

因應海外（東南亞）GMP細胞廠建置需求以及後續品質系統、細胞製程等工作，我們需要有志往海外發展，並對於GMP品質系統以及GTP/GMP幹細胞製程有經驗之夥伴加入。 職務說明如下： 1.協助海外GMP細胞工廠建廠事宜。 2.GMP品質系統建立。 3.GMP細胞製程管理與執行。 4.GMP戲胞工廠例行維護工作。 5.其他主管交辦事項。

1.執行有機化合物之合成與純化，包含反應條件設計與產物分析。 2.參與 Linker-Payload 的合成開發及 ADC Bioconjugation 實驗操作。 3.協助 ADC 藥物結構設計與專利可行性評估。 4.協助製程放大與優化，支援 Pilot Scale 製程執行及相關技術文件撰寫。 5.參與 ADC 實驗室之設計、管理與日常維護。 6.配合主管交辦之其他研究或實驗相關事項。

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. 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。

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。

我們正在尋找一位知識管理工程師，負責生產技術處內部知識的蒐集、整合與管理，讓寶貴經驗和專業知識能被充分利用與傳承。 [主要職責] 1. 知識檔案建立 [生產製程及倉庫管理] a. 與需求單位確立知識檔案目的、受眾、達成目標與效果、內容呈現形式 b. 影片(或簡報)內容的規劃、時程安排及追蹤 c. 影片(或簡報)前置作業安排、拍攝、剪輯、完成版 d. 跨部門溝通協調 2. 知識檔案管理與維護 3. 訓練課程安排、執行與追蹤 4. 知識管理相關事項及主管交辦事項

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。

-蛋白質純化: 執行包含抗體下游製程在內的蛋白質純化。 -蛋白質特性分析: 執行CE-SDS、ELISA、HPLC、DSC和LC/MS等蛋白質特性分析方法。 -數據解讀: 數據判讀與撰寫準確、易懂且即時的實驗記錄。

1. 下游製程(蛋白質純化或切向流過濾)操作 2. 製造設備管理 3. 生產文件及 SOP 文件撰寫 4. 其他主管交辦事項

1. 在指導下，可執行操作公司研發專案之MOA研究，包含自行開發方法、執行研究或委託外部研究 2. 在指導下，可執行操作公司研發專案之CMC需求研究子項目，包含自行開發方法、執行研究或委託外部研究。 3. 具備彙整跨單位或多來源資料整合分析能力，以進行系統化報告。 4. 具備數據分析彙整能力，以圖表呈現研發成果。 5. 與研發相關之主管交辦事項。

1. 微針處方設計與開發 2. 微針處方與成品之物化性檢測及規格確立 3. 開發微針成品所需之檢測分析方法 5. 研發技術文件撰寫 6. 實驗數據整理及報告撰寫 7. 安定性試驗執行 8. 其他主管交辦事項 工作地點：台北生技園區（捷運南港站2號出口）

1.執行藥品出口業務: 產品進出口業務，包含出貨進度、出口安排及與工廠生產排程 2.執行出口藥品安全監視 3.其他主管交辦事項 4.支援主管進行會議及內部簡報資料準備。 5.支援主管彙整國外客戶需求的送件資料。

1.蛋白質藥物純化製程開發與優化。包含TFF濃縮透析操作、AKTA 管柱層析純化、BSC無菌操作等。 2.蛋白質藥物純化製程放大與技術轉移，制定製程關鍵參數與操作範圍，撰寫製程技術轉移相關文件，以及支援 IND 相關文件的準備（下游部分）。 3.跨部門之團隊合作，解決製程中的技術問題。 4.協助實驗室設備維護。 5.其他主管交辦事項。

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