智新生技股份有限公司

Company Overview: We are an innovative biotech startup dedicated to the development of RNA-based therapeutics targeting infectious diseases. A core component of our platform involves leveraging extracellular vesicles (EVs)/exosomes for targeted delivery. As we expand our R&D capabilities, we are seeking a talented and detail-oriented Research Associate to perform method development efforts focused on EV characterization and culture condition optimization. Position Overview: The Research Associate – Analytical Development and Cell Culture will play an important role in developing and performing analytical methods to support process development, technology transfer, and quality control of EV-based therapeutic products. The ideal candidate brings strong experience in biological assay development, nanoparticle analysis, and cross-functional collaboration. Key Responsibilities: •Development of analytical methodologies and cell culture conditions •Perform routine analytical assays (e.g. ELISA, particle analyzer, flow cytometry, qRT-PCR), and other biophysical/biochemical methods. •Perform cell culture workflows •Collaborate with internal R&D teams and external partners to refine and validate analytical methods. •Support tech transfer by generating documentation, protocols, and quality control procedures. •Plan, execute, and document experiments independently within a multidisciplinary environment. Why Join Us? •Be part of a fast-paced, innovative team pushing the boundaries of RNA and EV-based medicine. •Collaborate with passionate scientists and industry experts on high-impact research. •Competitive compensation and benefits in a mission-driven startup environment.

Company Overview: We are an innovative biotech startup dedicated to the development of RNA-based therapeutics targeting infectious diseases. Our innovative platform integrates extracellular vesicle (EV)/exosome delivery systems to enhance treatment precision and efficacy. We are seeking a driven Research Associate to join our growing R&D team and contribute to the design and optimization of upstream processes supporting exosome-based drug development. Position Summary: The Research Associate – Upstream Development will play a key role in developing and executing upstream workflows to support exosome-based therapeutic production. This includes cell culture, vector construction, plasmid preparation, transfection, and culture condition monitoring. The ideal candidate will have strong hands-on experience in molecular biology techniques and cell-based production systems, and a solid understanding of upstream process development. This role requires a proactive and detail-oriented individual who is eager to learn, contribute to cross-functional projects, and grow within a fast-paced biotech startup environment. Key Responsibilities: • Develop and optimize upstream cell culture processes for EV/exosome production. • Conduct routine cell culture operations, including maintenance, condition monitoring, and scale-up. • Perform routine molecular biology experiments, including vector construction, plasmid prep, transfection, drug selection, and PCR/sequencing analysis. • Monitor and analyze EV/exosome yields and culture health using standard analytical methods. • Analyze experimental data and contribute to the development of SOPs and process documentation. • Collaborate with internal teams and external partners on upstream development, process optimization, and technology transfer initiatives. Why Join Us? • Contribute to the next generation of RNA therapeutics in a mission-driven startup. • Collaborate with passionate scientists and industry experts on high-impact research. • Competitive compensation and benefits in a mission-driven startup environment.

Company Overview: We are a pioneering biotech startup dedicated to developing RNA-based therapeutics for infectious diseases. Our mission is to harness the power of RNA technology to create innovative treatments that address critical global health challenges. As we continue to grow, we seek passionate and driven individuals to join our dynamic team and contribute to groundbreaking research. Position Overview: We are seeking a highly skilled and motivated Scientist to support our research and development efforts in RNA therapeutics. The ideal candidate will have extensive experience in molecular and cellular biology techniques, with a strong background in RNA science and extracellular vesicle (EV) biology. This role will play a crucial part in advancing our RNA-based therapeutic platforms, contributing to the design, execution, and analysis of cutting-edge experiments. Key Responsibilities: • Conduct hands-on research in in vitro cell culture techniques, including transfection, stable cell line establishment, and maintenance. • Design and execute molecular cloning strategies, including sequence design and vector construction. • Perform advanced analysis techniques such as qPCR, flow cytometry, and cell-based assays. • Investigate the role of EV/exosome biology in RNA-based therapeutic applications. • Explore RNA biology principles and contribute to RNA-based therapeutic development. • Collaborate cross-functionally with internal teams and external partners to drive research projects forward. • Analyze and interpret experimental data, prepare technical reports, and present findings in internal and external meetings. • Stay up to date with advancements in RNA biology, EV research, and nanoparticle drug delivery to contribute to the innovation pipeline. If you are passionate about RNA science and eager to contribute to groundbreaking therapeutic developments, we would love to hear from you. Apply now to be part of our innovative team!

Company Overview: We are an innovative biotech startup dedicated to the development of RNA-based therapeutics targeting infectious diseases. A core component of our platform involves leveraging extracellular vesicles (EVs)/exosomes for targeted delivery. As we expand our R&D capabilities, we are seeking a talented and detail-oriented Analytical Development Scientist to lead method development efforts focused on EV characterization. Position Overview: The Analytical Development Scientist – EV/Exosome Characterization will play a key role in developing and implementing analytical methods to support product development, technology transfer, and quality control of EV-based therapeutic products. The ideal candidate brings strong experience in biological assay development, nanoparticle analysis, and cross-functional collaboration. Key Responsibilities: • Develop and optimize analytical methods to characterize EVs/exosomes, including size, concentration, surface markers, and cargo content. • Establish robust and reproducible assays for proteins, nucleic acids, lipids, and EV complexes. • Support tech transfer by generating documentation, protocols, and quality control procedures. • Perform hands-on work using analytical platforms such as ELISA, flow cytometry, nanoparticle tracking analysis (NTA), and other biophysical/biochemical methods. • Collaborate with internal R&D teams and external partners to refine and validate analytical methods. • Plan, execute, and document experiments independently within a multidisciplinary environment. Why Join Us? • Be part of a fast-paced, innovative team pushing the boundaries of RNA and EV-based medicine. • Collaborate with passionate scientists and industry experts on high-impact research. • Competitive compensation and benefits in a mission-driven startup environment.

我們是智新生技，專注於新藥開發與 GMP 製造，現正尋找對「資深品保/品保(Sr.)QA/QA）」充滿熱情的你，一起推動品質系統、文件與稽核管理，確保產品與流程皆符合 PIC/S GMP 與法規要求，打造高標準的製藥品質。 ｜職務說明｜ 臨床一期先導工廠(資深)品保專員／品保專員 該職務涵蓋了品質管理系統的建立、維護、監督與改進，主要工作項目包括： 一.協助品質管理系統的建立與維護 • 制定、修訂並維護各項SOP（標準作業程序）、品質手冊及相關文件，確保所有作業流程符合PIC/S GMP等國內外法規要求。 • 協助品質系統的推行，並進行系統稽核，確保品質系統實施的有效性。 • 參與品質風險管理，進行風險評估，並制定風險控管措施。 二. 協助生產過程的監督與管制 • 監督原物料的選擇與處理、生產線的運作、半成品及成品的檢測與品質控制。 • 對不合格品的原因進行追查、分析、報告與處理，並提出矯正與預防措施（CAPA）。 • 處理偏差（Deviation）與異常事件，進行調查與追蹤，並提出改善方案。 三.協助文件與紀錄管理 • 審核並核准原料、包裝材料、半成品、中間產品及最終產品的檢驗報告和放行文件。 • 管理各類品質紀錄，如批次生產紀錄、檢驗紀錄、變更管制文件、客訴處理紀錄等，確保其完整性、正確性與可追溯性。 四. 協助內外部稽核與法規遵循 • 規劃與執行內部稽核，確保各部門符合GMP規範。 • 追蹤法規更新，確保公司品質系統與作業流程隨時符合最新法規要求。 五. 協助供應商管理 • 建立並維護合格供應商清冊，執行供應商評估與稽核，確保原物料品質符合標準。 • 監督委託製造與委託檢驗單位的品質管理。 六. 協助教育訓練 • 規劃並執行品質教育訓練計畫，確保藥廠員工對GMP理論與實務操作有足夠的了解，提升整體品質意識。

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

我們是智新生技，專注於創新藥物開發與 GMP 製造，誠摯邀請對「生技製藥倉儲管理」有熱忱，並具備中等英文能力的你加入！ ｜職務說明 | · 處理原物料之進貨、入庫、出貨與退貨等各項倉儲相關作業 · 執行原物料標示與定期盤點作業 · 建立並維護倉庫相關之 GMP／GDP 作業標準程序（SOP） · 掌握原物料交期狀況，並進行安全庫存管理 · 辦理進出口報關相關作業 · 協助並支援國內外採購相關事務 · 協助供應商管理作業及新廠商之開發 · 完成其他主管交辦事項 ｜Job Description | · All warehousing work related to the purchase, storage, shipment and return of raw materials · Raw material labeling and regular inventory operations · Establishment and maintenance of warehouse GMP/GDP related SOP · Understand the raw material delivery date and manage inventory stock · Import/export customs declaration · Assist in supporting domestic and foreign procurement related operations · Assist in supporting supplier management and new manufacturer development · Other matters assigned by the supervisor

我們是智新生技，專注於新藥開發與 GMP 製造，現正尋找對「生技廠設備與環安維運管理」有熱情的你，一起打造高標準、可長期發展的製藥設施！ 1｜廠務設備與系統維運｜ · 生技廠建廠系統（如電力、空調、壓縮空氣、製程氣體、廢水處理、中央監控 EMS/BMS）之監造、驗收、維護及故障排除 · 設備日常巡檢、抄表、校正排程、再驗證與預防保養 · 協助工程驗收、確效作業及報表文件管理 2｜設備與文件管理｜ · 管理設備校正、維修工單與圖說資料 · 撰寫與更新相關文件（如驗收報告、確效紀錄、作業 SOP） · 確保設施作業流程符合法規要求（如 PIC/S GMP、GMP） 3｜環安衛與合規作業｜ · 負責消防安全設備管理、防災演練規劃與申報作業 · 執行各項環保申報（空污、水污、毒化物、廢棄物、化學品）與配合外部檢測 · 配合主管交辦與內外部稽核要求，維持現場安全與法規遵循