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4/26 Manager/Deputy Manager of Medical Device R&D

  • 台北市南港區
  • 3年以上
  • 碩士

(1)R&D project management (2)Development of orthopedic implants (combination products) (3)Organization and execution of non-clinical studies (performance, pharmacology, toxicology, pharmacokinetics, biocompatibility, and other associated studies) (4)Industry-academia collaboration proposal/report writing (5)Establishing quality/technical documents in accordance with ISO or other guidance (6)Preparation of documents for product registration (7)Collection and analysis of competitive product-related information, scientific literature, and international regulations (8)Other assigned tasks

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0~5人應徵

4/26 化學分析 - 副研究員 Analytical Research - Associate Scientist

  • 台北市內湖區
  • 5年以上
  • 大學

Perform the following job duties with minimal supervision and guidance: 1. Perform stability studies for R&D formulation development. 2. Conduct method development and validation work. 3. Design and conduct analytical studies to help R&D product development. 4. Report study results and draw conclusions to the upper manager or study directions. 5. Follow SOPs, operate and maintain laboratory work under an eGMP quality system.

待遇面議 員工270人
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6~10人應徵

4/26 Flow Cytometry Associate Scientist/Senior Research Associate (流式細胞技術部副研究員/資深研究助理)

  • 台北市內湖區
  • 1年以上
  • 大學

CerbACT Asia provides testing services for both global and local clinical trials. As a perspective member of the Flow Cytometry Department, you are expected to perform routine flow cytometry testing, PBMC isolation, and cell culture, as applicable. You are also responsible for the maintenance of flow cytometers, cell counters, and other related instruments and equipment. You will be working under regulations of the College of American Pathologists (the CAP) and guidelines of the Good Clinical Laboratory Practices (the GCLP) under supervision of Scientist and Department Head. As a member of our team, you will have the opportunity to collaborate with our partner labs in the EU and the US. You will participate in assay transfer validations for cutting-edge flow cytometric assays, fostering your professional development. Responsibilities - Perform routine lab testing including flow cytometry, PBMC isolation, whole blood pelleting, (ultra)centrifugation, and cell culture, as applicable. - Maintain test results and all related records. - Analyze flow cytometry test results and draft test reports, as applicable. - Schedule maintenance of lab instruments. - Perform incoming material QC of antibodies, including inter-lot and inter-shipment comparisons. - Assist in maintaining adequate laboratory supplies. - Document all tasks performed according to company’s Quality Management System (QMS) and policies. - Participate in regular meetings and discussions and present data internally. - Revise SOPs to improve the workflow. - Any other department tasks assigned by supervisor. CerbACT Asia 為全球和台灣當地臨床試驗提供測試服務。 作為流式細胞技術部門的正式成員,您需要執行常規流式細胞儀測試、PBMC 分離和細胞培養(如果適用)。 您也負責流式細胞儀、細胞計數器以及其他相關儀器和設備的維護。 您將在研究員和部門主管的監督下,按照美國病理學家學會 (CAP) 的規定和優良臨床實驗室規範 (GCLP) 的指南之下進行工作。 作為我們團隊的一員,您有機會與我們在歐盟和美國的合作夥伴實驗室合作。 您將參與尖端流式細胞儀檢測的檢測轉移驗證,以促進您的專業發展。 工作職責 - 執行常規實驗室測試,包括流式細胞儀、PBMC 分離、全血沉澱、(超)離心和細胞培養(如果適用)。 - 維護測試結果和所有相關記錄。 - 分析流式細胞儀測試結果並草擬測試報告(如適用)。 - 安排實驗室儀器的維護。 - 對抗體進行進料品質控制,包括批次間和裝運間比較。 - 協助維持充足的實驗室用品。 - 記錄根據公司品質管理系統 (QMS) 和政策執行的所有任務。 - 參加定期會議和討論並在內部展示數據。 - 修改 SOP 以改善工作流程。 - 主管指派的任何其他部門任務。

待遇面議 員工8人
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6~10人應徵

4/26 學士級兼任研究助理

  • 台北市中正區
  • 經歷不拘
  • 大學

[單位名稱] : 臺大醫院 基因醫學部 生化遺傳研究室 [職務名稱] : 學士級兼任研究助理 [工作內容] : 執行「罕見疾病一點通」計畫內容 (包含「罕病一點通」網站維護管理(參考網址: https://web.tfrd.org.tw/)、罕病宣導活動/文宣發想或執行、衛教文章彙整…) [應徵資格] : 1. 國內外分子醫藥、遺傳或生物相關科系學士學位(兼任助理)。 2. 具社群健康專欄經營、文獻/衛教文章/文案撰寫經驗尤佳 3. 具研究熱忱及經驗。 [薪資待遇] : 依國科會標準 [聯絡方式] : 請備妥以下資料並以Email寄送,如通過初審將會另行通知與面試。 1. 個人履歷(含學歷、研究與工作相關經驗、著作列表);2. 大學及研究所成績單;3. 其他有助審查資料,如論文著作、過去撰寫文章記錄、作品等。 聯絡人:葉小姐 聯絡電話:(02) 23123456-271939 E-Mail:[email protected]

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0~5人應徵

4/26 R&D Research Assistant (Non-oral)

  • 台北市內湖區
  • 經歷不拘
  • 大學

主要職務: 1. 協助處方設計與製程開發之相關試驗執行,數據整理 2. 完成主管交辦事項 詳細職務內容: 1. 執行處方設計與製程開發試驗 2. 試驗結果整理與報告 3. 維護儀器的完整性及清潔 4. 原物料控管 5. 協助部門間及廠商的聯絡 6. 完成主管交辦事項

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6~10人應徵

4/26 臨床評估專員 Clinical Evaluation Specialist

  • 台北市南港區
  • 2年以上
  • 大學

美康諾生醫是以法規科學為核心的創新醫療產品公司,致力於提供使用者安全、有效且高品質的醫療產品與專業服務。 「正直誠信」、「專業承諾」、「科學創新」、「信任尊重」是我們的核心價值。 此職位將與行銷團隊及臨床專家有密切的溝通及合作,負責產品及臨床知識推廣,將安全有效的醫療產品與正確醫療科技知識傳遞給每位使用者與合作夥伴,共創一個值得信賴的專業醫療品牌企業。 歡迎對醫療產業有熱忱且對臨床研究具有經驗的專業夥伴加入團隊,這裡充滿機會與挑戰,不僅提供您在專業上的持續成長,工作上也提供豐富的發揮空間。我們希望作為實現夥伴職涯目標的平台,期待有您的加入,一起為台灣醫療產業做出貢獻,提升國人健康福祉! [工作內容] • 負責產品臨床評估計畫與報告 • 規劃及執行產品上市後臨床追蹤 • 規劃及執行上市後監督 • 撰寫定期安全性報告 • 醫學相關文獻檢索及審閱 • 負責醫療產品廣告審查申請 • 協助規劃與舉辦各類研討會及展會活動 • 建立及維護臨床專家及顧客關係 • 協助產品及臨床問題諮詢與訂購確認 • 負責公司臨床知識及法規教育訓練 • 國內外臨床法規及標準更新與維護 • 具備專案管理能力 • 其他交辦事項 [必要條件] • 正直誠信、專業負責、積極主動、追求卓越 • 具備自主學習、獨立思考、邏輯分析與解決問題能力 • 具備跨部門團隊合作與溝通協調能力

待遇面議 遠端工作 距捷運南港站約270公尺
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6~10人應徵

4/26 Director/Manager, Reagent and Kit Development

  • 台北市南港區
  • 6年以上
  • 碩士

We are seeking a highly motivated director or manager to lead the development of new reagents and reagent kits. The main responsibility of this position is to oversee the commercialization of new chemical and biological reagents, as well as consumable products. You will be responsible for managing, the development and production of chemical biology products for our next-generation spatial proteomics platform. You will lead internal R&D and external CDMO/CMO teams to ensure that new and existing products meet market demand. Responsibilities: • Lead the development of reagent products to commercialize reagent kits and consumables • Manage teams to bring reagent and consumable products from research concepts to production and commercialization. • Interface and coordinate with R&D and CMO/CDMO to ensure project activities can be completed on time and meet performance goals • Drive New Product Introduction process for reagents and consumables • Provide scientific and technical expertise to establish product specification. • Lead the design, development, and execution of test procedures for verification and validation studies. Standardize and establish quality control assays for the consumables • Optimize the workflow of reagents to ensure robust performance and reagent stability, while ensuring that the workflow is user-friendly for customers. • Lead continuous improvement and sustaining efforts for products and processes in support of cost and performance objectives • Conduct on-market product sustaining activities including troubleshooting quality issues, conducting root-cause analyses, and implementing corrective actions • Contribute to the company's intellectual property portfolio by documenting results and filing for IP protection • Direct the creation of comprehensive documentation, SOPs and reports for product commercialization in collaboration with internal and external resources, including engaging decision-makers and partners Qualifications: • MS or PhD degree in biochemistry, chemical biology, chemistry, chemical engineering, bioengineering, molecular biology or a related discipline • Requires at least 6 years of industrial experience with demonstrated experience taking projects from early research through commercialization, preferably in the life science tool or medical device industry • A minimum of 2 years of managerial experience is required • Rigorous product development experience is required, particularly related to reagent development, formulation, manufacturing and packaging • Experience with organic synthesis and/or small molecule product development is required • Experience with antibodies and/or other affinity-based reagents is required • Experience with functional/analytical assays to qualify and evaluate reagent performance is required • Experience working within regulated environments (GMP, GLP, ISO, FDA, IVD, LDT, etc.) is strongly preferred. • A high level of commitment and a track record of quality work, with attention to detail. Capable of communicating the work clearly among the team • Hands-on experience with in situ molecular biology protocols (immunohistochemistry or FISH) and fluorescent microscopy imaging is a plus • Keen understanding of molecular biology techniques • Strong communication and collaborative skills, working with internal and external colleagues and regulatory disciplines. • Strong analysis, including process statistics, and problem-solving skills to meet market needs • Excellent organizational and time management skills • Ability to manage progress of an unfamiliar knowledge domain

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0~5人應徵

4/26 法規事務處-助理研究員

  • 台北市內湖區
  • 經歷不拘
  • 大學

TW Part 1. Product Lifecycle Management 。 Post-approval Change 。 Control Correspondence 。 Labeling Revision 。 License Maintenance 2. DMF application and maintenance 3. Management of National Health Insurance Reimbursement Price 4. Apply import/export permission for API and RLD (commercial & R&D) 5. Assist Inspection 6. Other temporary matters assigned by supervisor US part 1. To assist in ANDA application 2. Other temporary matters assigned by supervisor

待遇面議 員工270人
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6~10人應徵

4/26 Medical Research Scientist

  • 台北市松山區
  • 2年以上
  • 博士

【 Who We Are 】 We are dedicated to driving a revolution in the medical field, leading the charge in technological advancements that will shape the future of healthcare. Through the power of AI, we strive for breakthroughs in drug development, tackling numerous human health challenges. Join the future of the pharmaceutical industry by joining our team at the American Graphen AI Company! We cordially invite you to take on the role of Research Assistant and be at the forefront of innovative technology. 【 What You'll Do 】 - Be able to design, conduct, and deliver research studies independently, with minimal support from the project leader - Support team lead to finish the research studies including paperwork (patent and publish) - Cooperate and communicate with team membranes and partners to design/discuss in-vitro and in-vivo POC experiments. - Manages the process of proposal preparation and modifications - Support drug target studies and plot for our drug pipelines - Write IND-related and experiment documents 【 Minimum Qualifications 】 - Have at least 2 years experience in Biomedical writing (please provide portfolio) - Have at least 3 years experience in Biomedical wet lab experience (Before the Interview will have a test) - Be able to maintain and design an explainable deck - Have experience in wet lab experiment design - Familiar with Regulatory documentation and paper writing - Background in Biochemistry, Biomedical, or clinical/wet/dry lab - Have a strong ability of problem-solving - Good level of adaptability and an ability to learn quickly 【 Nice To Have 】 - Have a passion to understand Machine Learning / Deep Learning for drug development - Familiar with chemical compound synthesis - Familiar with Oncology/Metabolic disease/Neurological disorders/Cardiovascular Disease - Good debugging and performance profiling skills for Python

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11~30人應徵

4/26 副研究員/研究員

  • 台北市內湖區
  • 經歷不拘
  • 碩士

• Work hands-on in the laboratory to develop, optimize, qualify, transfer, and validate analytical test methods for both drug substance and drug product, from preclinical nomination through late-phase clinical development; • Conduct in-house stability studies and interpret stability data to justify material use periods; • Build kinetic stability models for formulation screening and packaging selection; • Author high-quality documentation, including methods, protocols, and technical reports; • Coordinate and oversee method validation and testing at contract laboratories and manufacturers; • Collaborate with others scientists on CMC teams to meet program goals; • Act as an exemplary and data-driven scientist with critical thinking and innovative problem solving skills in a fast‑paced, can-do environment.

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0~5人應徵

4/26 業務專員-生物製程部

  • 台北市南港區
  • 經歷不拘
  • 大學

1.生物製程相關試劑/耗材/儀器銷售 2.與國外原廠關係建立並擔任產品相關銷售之聯繫工作 3.具基本英文能力及新知識學習能力 4.具主動積極企圖心,團隊向心力,良好構通能力 5.生物學. 生命相關科系等 <接觸過生物反應器實驗者尤佳>

待遇面議 員工88人
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0~5人應徵

4/26 【Parexel校園徵才講座-4&5月】與CRA、CDA、SP等心儀職缺、與主管最近距離了解的機會!

  • 台北市信義區
  • 經歷不拘
  • 大學

你是否對於CRO產業是什麼感到好奇? 對於與來自世界各國的夥伴工作溝通感到興趣? 無論即將畢業尋求一個好的職涯開展,或者想轉換更好的工作機會,現在!! 即刻報名!! ◆Parexel 百瑞精鼎校園徵才講座 – 台大、北醫、陽明交大多場次、多種職缺等你來了解! ◆ Parexel 百瑞精鼎是藥物臨床試驗產業中,全球頂尖的的臨床研究委託機構,總部位於美國,於全球有72個辦公室,近21,000員工,台灣為亞太區核心據點,共有60幾個部門提供職涯發展。 近期榮獲WCG CenterWatch頒發的2022年與clinical trails sites合作最好的CRO與FlexJobs頒發的2023年百大彈性工作企業Top 100 Remote Work等兩項大獎,除了提供新人完善專業的培訓、也提供彈性的上班環境及優渥的福利制度。 本次校園講座活動皆邀請到各部門主管、同仁,甚至還有實習生,帶領大家認識CRO產業、CRA、CDA、SP等多種職缺工作樣貌,還能聽到在Parexel百瑞精鼎上的職涯發展、經驗等分享,搶在投遞及面試前先了解,提升加入Parexel百瑞精鼎的機會!! ▶ 4月份場次-台大&北醫 ❖台灣大學 統計中心 講座 *本場次需事先於中心網頁報名 ❚時間:2024年4月17日(三) 14:30~16:30 ❚地點:台灣大學 校總區-普通教學館504 (臺北市羅斯福路四段一號) ❚分享職位:Statistical Programmer (SP) ❚報名網頁:https://my.ntu.edu.tw/actregister/sessionView.aspx?actID=2024C100_01&sesID=1 ❖北醫 DREAMERS 講座 *本場次需事先於社團網頁報名 ❚時間:2024年4月24日(三) & 25日(四) 18:00~21:00 ❚地點:台北醫學大學 (臺北市信義區吳興街250號) ❚分享職位: 4/24 - Regulatory Affairs Specialist 4/25 - Clinical Research Associate (CRA), Clinical Data Analyst (CDA), Statistical Programmer (SP) ❚報名網頁:https://lnkd.in/gQwxg2AF ▶ 5月份場次-台大&陽明交大&北醫 ❖台灣大學 BESA社團 講座 *本場次需事先於社團網頁報名 ❚時間:2024年5月9日(四) 18:30~21:00 ❚地點:台灣大學 (臺北市羅斯福路四段一號) ❚分享職位:Project Specialist, Clinical Data Analyst (CDA), Site Intelligence Analyst ❚報名網頁:後續公告 ❖陽明交大(陽明校區) 講座 *本場次需事先於學校網頁報名 ❚時間:2024年5月14日(二) 12:00~13:30 ❚地點:陽明交通大學 陽明校區 (台北市北投區立農街二段155號) ❚分享職位:Clinical Data Analyst (CDA), Statistical Programmer (SP) ❚報名網頁:https://docs.google.com/forms/d/e/1FAIpQLSf69BQW0v5w5vf7teh7JJy76co7e5FmkecJG-VamJO0-JZoeA/viewform ❖台北醫學大學 公共衛生學系講座 *本場次需事先於學校網頁報名 ❚時間:2024年5月15日(三) 12:10~13:10 ❚地點:台北醫學大學 雙和校區 (新北市中和區圓通路301號) ❚分享職位:Statistical Programmer (SP) ❚報名網頁:https://forms.gle/hH55sGKisPs4U7Ez7

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0~5人應徵

4/26 研發專員

  • 台北市南港區
  • 經歷不拘
  • 大學

【工作內容】 1.進行外泌體新藥與製程開發等相關試驗。 2.進行純化、配方等相關開發測試。 3.參與各項專案或研發實驗設計、進行與分析。 4.搜尋整理文獻。 5.協助行政事務處理。 6.其他主管交辦事項。

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0~5人應徵

4/26 研究部-專任研究助理

  • 台北市信義區
  • 經歷不拘
  • 大學

學歷: 學士級(含)以上研究助理一名 工作內容: 1.協助科技部研究計畫相關實驗(如細胞培養、RT-PCR, immunoblotting、transfection, reporter assay, flow-cytometry等) 2.實驗室相關庶務 具備文件: 標題請註明【應徵學/碩士級研究助理】,並請檢附以下資料: 個人履歷及其他有助於審查之相關輔助資料 (如推薦信,碩士論文、相關研究著作目錄,最高學歷與相關證書)。 聯絡方式: 意者請e-mail至[email protected] 甄選方式: 1. 藥學、生命科學相關科系。 2. 熟悉細胞培養、基礎分子生物技術或有動物實驗、新藥開發研究相關工作經歷尤佳。 3. 耐心、負責,具學習熱誠。 【其他備註】 將擇優通知面試,未達條件者恕不函覆。 依照科技部專任助理人員工作薪資。年終獎金:1.5個月(依到職比例計算)、享勞健保。

待遇面議 員工2400人
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0~5人應徵

4/26 (台北)經理 regulatory affairs manager

  • 台北市內湖區
  • 3年以上
  • 大學

Maintenance of existing GDP system and prepare relevant policies and SOPs per regulation requirements. Product licensee coordinator to help BD staff to prepare relevant documents to potential investors. Responsible for the tasks issued by supervisor within the expected timeline.

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0~5人應徵

4/25 (Associate) Project/CMO Manager

  • 台北市南港區
  • 2年以上
  • 碩士

Essential Duties and Responsibilities: The (Associate) Project and Contract Manufacturing Manager serves as the crucial liaison between the CMC division and CMOs, facilitating project coordination and communication among key stakeholders. This role collaborates closely with internal Project Leaders, CMC functional teams (Technical Transfer, Process and Analytical Development, and QA), and CMO/Partners to realize corporate objectives. The primary focus is on supporting projects across various phases at CMOs, encompassing technical transfer, clinical trial material supply, registration activities, and eventual commercial supply, while overseeing schedules and budgets. We are flexible to consider more junior or senior roles depending on candidate qualifications. 1.. Developing and drive timeline from technology transfer to GMP batch manufacturing for clinical supply, registration use and commercial supply. 2.. Manage external packaging, labeling, warehouse storage, and logistical activities on a monthly basis, tailored to project-based and commercial requirements. 3.. Facilitate communication between internal project team members and external CMOs through email, phone calls, meetings, or face-to-face interactions to address issues, milestone prerequisites, and project progress. 4.. Evaluate and recommend suitable CMOs for each project development phase through meticulous due diligence, assessment of investment requirements, and operational insights provided into agreements. 5.. Identify risks and devise mitigation strategies to ensure project timelines are met, collaborating closely with senior management. 6.. Coordinate project timelines, budgets, activities, and direction to align with corporate objectives. 7.. Collaborate with the business development team and external partners to map out commercial supply strategies. 8.. Negotiate contracts with CMOs (working in tandem with the Business Development team), prepare and monitor Purchase Orders, and track invoices according to project progress.

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0~5人應徵

4/25 Clinical Research / Regulatory Affairs - 臨床試驗/法規事務

  • 台北市內湖區
  • 經歷不拘
  • 大學

- Manage the regulatory activities of medical products - planning, reviewing, and coordinating regulatory submissions. - Cooperate with internal and external partners to manage the timeline and quality of the CTD dossier. - Participate in the pre-IND and IND projects to facilitate new drug development. - Ensure compliance with the EMA/US FDA/TFDA regulations. - The title will be commensurate with experience.

待遇面議 員工80人 遠端工作 距捷運西湖站約220公尺
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11~30人應徵
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