協助浩宇生醫進行產品臨床支援及醫療器材應用及開發，包含： 1.瞭解產品研發過程並與研發團隊合作，溝通及管理產品研發及上市流程。 2.熟悉公司產品之療法，應用與操作，幫助臨床人員在病患治療或臨床試驗時正確使用公司產品，並解決產品使用上之問題。 3.臨床試驗執行，包含術前規劃，協助並訓練醫師操作產品，術後資料蒐集、分析、整理及歸檔等。 4.國內、外產品裝機、展示、教育訓練。 5.其他主管交辦事項。
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.
工作內容說明： 1. 申請動物計畫 2. 規劃並執行動物實驗 3. 整理及報告動物實驗進度 4. 規劃及操作分子及細胞實驗 5. 研究文獻、實驗資料搜集、分析及報告 6. 訂購實驗室藥品耗材及報帳等 7. 其他臨時交辦事項
**Job Responsibility: 1. Clinical study protocol (CSP) expansion/development/assessment. 2. Development of clinical study report (CSR)/interim and annual report. 3. Investigator’s brochure (IB) development. 4. Study-related document development/ePublishing. 5. Attendance of project meetings with sponsors. 6. Preparation for regulatory/CDE/TFDA/FDA consultations and meetings. 7. Implement the cross-QC system. 8. Communications and coordination of the projects with sponsors 9. Statistical sample size/power consultancy. 10. Perform other company-related duties as assigned by the manager. 工作待遇 : 面議 (年薪14個月+獎金) **Education/ Qualifications: 1. MSc, PhD, or MD degree in life science/pharmacy/medicine/public htelath, with a minimum of 2-year experience in clinical research or in medical/scientific writing. 2. Quality-oriented, accurate, detail-oriented, and responsible working attitudes to provide deliverables on time. 3. Self-motivated, flexible, creative, able to prioritize, multi-task and work in a fast-paced and demanding environment. 4. Good inter-personal skills and time/project management skills. 5. Good written/oral English and Chinese and other required language skills. 6. Familiar with GCP principles and related ICH guidelines. 7. Good medical/scientific writing and ability to adapt style/content to different readers/audiences. 8. Good editing and QC skills. 9. Good computer skills, including MS Office, PDF formats, scientific graphing. 10. Ability to search different databases, e.g., PubMed.
- Develop sustained release dosage forms such as solutions, suspensions, micro- or nanoparticles, and implants. - Prepare and characterize test samples for internal and collaborative projects. - Plan and conduct lab experiments to develop and optimize formulations and manufacturing processes. - Generate and test formulations for biological evaluation (in vitro and in vivo) of prototypes and optimized versions. - Document lab experiments, analyze data, interpret results, and write technical reports. Stay current with scientific advancements in drug delivery and development.
• Provide scientific and technical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance to Abbvie. • Ensure a strong medical and scientific presence for Abbvie in key academic centers by facilitation of research and educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to Abbvie. • Support internal teams such as sales and marketing and members of the Affiliate Brand Team to develop their scientific and technical expertise through the delivery of scientific update presentations. Work collaboratively and cross-functionally with other in-field members while retaining functional independence. • Serve as a point of contact within the Medical Affairs team for thought leaders and external experts within assigned therapeutic area in order to satisfy their needs for scientific knowledge in a therapeutic area and, when requested, relevant AbbVie medicines, to support their safe, effective and appropriate use. • Deliver credible presentations on scientific matters to physicians, individually or in groups (meetings, clinical sessions, etc.), where requested, but with the focus on Tier 1 and 2 thought leaders. • Participate in the selection process to identify appropriately qualified thought leaders the Company would wish to engage in collaborative efforts – such as potential research collaborations, or educational and advisory roles (Advisory Boards, Congresses, Symposia, etc.); while ensuring a high level of scientific or educational integrity in these collaborative efforts. • Facilitate medical and scientific field intelligence – for example, competitor research and medical strategies, educational activities – and communicate, where appropriate, within the Company. • Attend relevant scientific meetings and Conferences. Collaborate with internal stakeholders to develop summaries of key data and other scientifically relevant information to inform Abbvie strategic priorities and initiatives. • Provide key thought leaders / external experts and internal medical and clinical teams with scientific and technical support for publications of scientific or medical interest.
每位員工都是成就諾倫的重要動力，你將會協助血液細胞製備的相關事項。 實驗室人員 周休二日，需要輪假日班 工作內容 1. 協助臨床血液檢體處理。 2. 按照固定SOP獨立操作實驗。 3. ⾏政庶務-文獻搜尋、庫存盤點與訂購、其他主管交辦事項。 4. 細胞培養、免疫螢光染⾊。 新加入的成員一定會經過教育訓練 沒有血液處理或免疫染色經驗者別擔心 只要積極學習一定可以上手的 加分項: 細胞培養相關經驗更佳
1. 具CRA/CTA至少2年經驗及執行臨床試驗能力 2. 與臨床試驗執行單位及人體試驗審查及問題溝通協調 3. 臨床試驗執行與收案進度追蹤 4. 臨床試驗監測與試驗品質控管 5. 臨床試驗法規審查資料準備與送件 (TFDA, IRB) 6. 臨床試驗相關資料整理歸檔 7. 其它交辦事項
1.基本E.Coli(大腸菌)細胞培養 2.基本分生實驗 3.小量蛋白純化 4.抗體製備 5.真核生物生產細胞株開發 6.遺傳工程 7.其他主管交辦事項
1. 新品企劃&開發 2. 產品開發品質&流程管控 3. 原料素材尋找與評估 4. 產品試製與量產製程設計 5. 相關食品認證申請規劃、執行與管理
1.研究食品、保健食品之加工、調理、配製。 2.在新產品製造階段進行實驗室研究。 3.進行食品原料蒐集、分析等工作，並建立自己的資料庫。 4.實際調整成分、製作樣品(果凍、飲品、粉包、膠囊、膏類產品)，並學習研究國內外的新知識新技術。 5.確保工廠大量製造時的品質穩定度。 6.製程改善。 7.其他主管交辦與公司指派之專案或任務。 (因組織擴大，今年九月會搬遷至中和中原站約700坪新辦公室，歡迎能配合未來搬遷至中和工作有緣人)
We are seeking highly experienced laboratory technicians to join our biochemical R&D team. The main task of this position is to follow standard operating procedure (SOP) to prepare the samples for LC-MS analysis. You will learn the knowledge and practical skills related to the LC-MS based proteomics. Responsibilities • Strictly follow standard operating procedure (SOP) to prepare samples for LC-MS analysis. • Perform cell lysis, immunoprecipation, enzymatic digestion, and sample submission to LC-MS. • Ensure consistent sample quality • Perform basic data processing • Perform other tasks as needed Qualifications • Master’s degree or above in biology, cell biology, biochemistry or related fields • 2+ years of industry experience in biotechnology or related fields • Practical experience in the Quality Control department of a GMP factory or an ISO lab is highly preferred • Hands-on experience in LC-MS related approaches is a plus • Ability to create clear reports and documentation • Self-initiative and able to work independently in a fast-paced team environment
每位員工都是成就諾倫的重要動力，你將會協助 ──生物組織製備相關事項，透過謹慎的處理手法，幫助立體影像有絕佳的螢光染色成果 工作內容 1.生物組織樣本製備（免疫螢光染色） 2.相關儀器操作及維護 3.產線活動期間品質維護、進度與問題回報 4.樣本簽收、管理、儲存及清運 5.文獻閱讀 6.維護日常文書表單紀錄 7.主管交辦事項
1.負責新產品製程的導入，並進行製程的檢測，以使新產品能夠穩定生產且符合相關標準。 2.持續改善現有生產製程。 3.制訂製造程序與產品標準。 4.評估製程專案計劃，訂出最適化的製造流程。 5.新試片開發驗證。 6.其他主管交辦事項。 本職位負責新產品製程的導入並進行製程的檢測，持續改善現有生產製程，具有相當重要的地位和發展前景。 歡迎符合條件的求職者投遞履歷，期待您加入我們！
1. 參與新產品的研發與開發。 2. 負責聽力防護的研究和開發。 3. 動物實驗與手術。 4. 管理實驗儀器。 5. 遵循公司的安全和品質標準。 6. 協助主管安排工作日程。
1.熟悉PCR相關,臨床檢體相關實驗設計及執行 2.產品研發專案主導與執行、Trouble shooting。 3.協助實驗室產品專案開發之進度掌控 4.實驗結果分析,實驗報告,品質文件與技術文件產出(撰寫設計開發流程文件) 5.主管交辦事項
Identify and interpret relevant regulatory guidelines. Prepare, coordinate, and supervise regulatory submissions. Communicate with regulatory agencies regarding pre-submission. strategies, potential regulatory pathways, compliance requirements, or clarification and follow-up of submissions under review. Work with cross-functional teams and communicate the submission requirements when documents are needed for regulatory submission. Keep current with the latest regulations and guidelines. Advise others on regulatory and compliance matters. Research and analyze scientific and medical information from various sources, including journals, online databases, and clinical studies. Write and edit technical/clinical documents to support regulatory submission (e.g., common technical documents, clinical protocol, clinical study reports, IB, and/or ICFs) and compile submissions in a format consistent with applicable guidance documents. Provide technical review of data or reports that will be incorporated into regulatory submissions. Assist in preparing responses to regulatory authorities’ questions within assigned timelines. Ensure that documents undergo a quality check before finalization. Perform other related duties as assigned.
1.食品/化學化工/醫檢相關科系畢 2.負責任、肯學習、有團隊精神 3.熟悉電腦文書處理作業 4.其他主管交辦事項。
Job Overview: Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions: • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. • Collaborate and liaise with study team members for project execution support as appropriate. • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
* 凡對新創公司、精準醫療、癌症研究等領域有興趣、有熱情的博士級人才，歡迎應徵申請。 工作內容： * 20%時間會需要進實驗室操作實驗。 * 80%時間執行專案經理與法規認證等相關作業，並且協助業務團隊在醫院做科會說明以及開拓國內外市場。 * 負責統籌、規劃與監督實驗研究專案的進展，確保項目按照計畫進行。 * 負責與研究人員溝通協調，促進團隊合作與效率。 * 制定並監督實驗研究項目的預算與資源配置。 * 負責確保實驗研究遵循適用的法律規範和標準，並確保實驗過程的安全。 * 統籌和記錄實驗結果，並協助研究人員分析數據。 * 協助實驗室認證準備。 * 協助撰寫研究論文和報告，並參與專業會議與研討會。 * 完成主管交辦事項。