「Bioinformatics Specialist」的相似工作

MAKE RESEARCH HAPPEN《陪科學家不斷前進，為科學研究提供最佳解決方案，為科學創造無限價值》 ✔生物資訊工程師工作內容 1. 協助開發與維護分析流程 2. 自動化流程與報告產出 3. 客製化案件分析 4. 內部教育訓練 ★ 其他條件 1. 熟悉 R 語言 2. 具NGS分析經驗 3. 蛋白質體學與MASS Cytometry 背景知識與實務經驗 4. 流程化工具(Snakemake)使用經驗 5. 基本Linux 操作及統計概念 6. 一年以上生物資訊實務經驗

• 利用人工智慧框架（如 TensorFlow、PyTorch）建構與訓練AI模型，解決生物資訊相關問題 • 爬取並整理公開資料庫的數據，進行資料清理與預處理，作為機器學習模型的訓練材料 • 進行次世代定序（NGS）資料分析，從大量生物資訊數據中擷取有用資訊並產出報告 • 撰寫與維護 Python 程式碼，開發數據分析工具和自動化流程，提高分析效率 其他條件： • 3年以上相關工作經驗，曾從事生物資訊分析或機器學習模型開發 • 精通 Python 程式設計，能獨立撰寫與維護程式碼；熟悉 TensorFlow、PyTorch 等深度學習框架並有實際專案經驗 • 具備次世代定序（NGS）數據分析經驗，理解基因體序列數據處理流程；熟悉資料擷取、整理與大數據分析方法

About the Role BeOne Medicines is seeking an enthusiastic and highly motivated Senior Research Investigator / Senior Scientist with expertise in gene engineering and genome analysis to join our Cell Therapy team. The successful candidate will play a key role in developing innovative genome engineering platforms to advance next-generation cell therapies. This role is responsible for leveraging the company’s proprietary technologies to design and deliver cutting-edge engineered cell products for clinical applications. Key Responsibilities • Design, execute, and optimize gene engineering strategies (e.g., targeted knock-in/knock-out, transgene integration, advanced editing technologies) in mammalian cells to meet project goals. • Independently derive, screen, and characterize engineered clones with strong hands-on execution, integrating molecular biology and genome analysis, while supporting routine lab maintenance to ensure efficient workflows. • Support NGS-based analyses (Illumina etc.) to evaluate desired modifications and genome stability. • Collaborate with bioinformatics, discovery, and development teams to deliver high-quality engineered cell therapy products. • Present scientific data and engage colleagues in technical discussions at internal project meetings. • Maintain a strong laboratory presence and contribute to an innovative, collaborative team environment. Qualifications Required: • PhD in Molecular Biology, Gene/Genome Engineering, Immunology, bioinformatics or related biological sciences with ≥3 years of relevant experience. (academic experience post-graduate also considered) • MS in Molecular Biology, Gene/Genome Engineering, Immunology, bioinformatics or related biological sciences with ≥5 years of relevant experience. • Proven hands-on experience with gene engineering technologies (e.g., CRISPR, viral vector, TALEN, mRNA delivery platforms) in mammalian cells (e.g., knock-in/out, transgene insertion, targeted modifications). • Strong molecular biology skills (e.g., cloning, PCR/qPCR/dPCR, Sanger sequencing, NGS analysis). • Knowledge or experience in developing and characterizing engineered cells. • Demonstrated ability to work in a dynamic, fast-paced environment with strong teamwork and problem-solving skills. • Excellent organizational and communication skills; proven ability to manage multiple projects under tight timelines. Preferred: • Experience with engineered cell therapy or gene therapy development (iPSC, MSC, T cells, NK, stem cell). • Familiarity with bioinformatics, pathway analysis, or NGS data interpretation. • Experience with advanced molecular biology techniques and flow cytometry. • Knowledge of genome analysis approaches for engineered cell therapy products.

招募熱忱且細心的研究助理，加入我們的實驗室，支援研究與實驗工作，並協助維持實驗室日常運作。主要工作內容如下： 1. 協助進行科學研究與生物實驗 2. 整理並分析實驗數據 3. 文獻查詢、彙整與報告撰寫 4. 協助實驗室管理與採購 5. 指導學生進行實驗操作 6. 協助撰寫研究計畫與成果報告

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. 具ISO13485相關經驗者佳 5. 執行次世代定序實驗與導入新興技術與應用。 6. 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。

1.學名藥與新藥臨床一期試驗設計、計畫書撰寫、藥物動力學數據運算、試驗報告撰寫 2.臨床前藥物動力學數據計算與分析，試驗報告撰寫 3.藥物學術文獻彙整評估 4.法規單位函詢與意見回覆 5.台灣/歐美臨床試驗法規 6.一年以上相關工作經驗優先

工作內容： 1. 負責醫療設備與資訊系統（NIS、LIS）、醫院資訊系統（HIS）、自動化設備之整合與系統設定 2.執行設備通訊介接（如 ASTM、HL7、TCP/IP、RS-232 等），確保資料準確傳輸與自動上傳 3.安裝、設定並維護醫檢儀器相關的軟體與工作站系統 4.針對醫院端提供技術支援、故障排除與操作說明，提升設備資訊穩定性 5.協助完成新設備導入、測試、資料驗證（validation）與驗收作業 6.配合業務與應用團隊，參與客戶簡報、專案討論與客製化整合提案 職務需求： 1.資訊工程、生物醫學工程、醫學科技、自動控制或相關理工科系大學以上學歷 2.具基本網路架構與伺服器架設概念，能操作Windows Server、SQL、網路安全等基本設定 3.熟悉RS-232、HL7、LIS/HIS流程者佳 4.良好的溝通能力與問題分析能力，能配合現場作業與出差安裝需求 5.具備工作紀律，能獨立作業並處理多任務專案管理

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. Manage the operation of MT and aid physicians in the diagnosis, treatment, and prevention of diseases by testing patient specimens, correlating data, and reporting results in a timely manner to effect quality patient care. Responsibilities: Perform analysis work according to SOPs and guidance. Prepare, review, and approve various documents, including SOPs, protocols, reports, and analytical methods. Manage lab logistics, including purchasing, inventory control, and payment processing. Maintain instruments and ensure cleanliness and maintenance of the workspace. Take on the role of system owner for computerized systems, performing tasks such as validation tests, periodic reviews, and reporting. Attend training courses related to CAP/GCP/GLP/regulatory requirements. Study Based Responsibility (if needed) Analytical Study Director in Study Work as the Study Director, responsible for the overall conduct and final report of the study. Approve the study plan and any amendments by signature, and ensure Quality Assurance personnel receive timely copies. Make study plans, amendments, and SOPs available to study personnel. Ensure procedures in the study plan are followed and document deviations and take corrective action if necessary. Document and record all generated raw data. Validate computerized systems used in the study, sign and date the final report to indicate acceptance of responsibility for data validity, and ensure study materials are archived after completion. Study Personnel in Study Ensure personnel are knowledgeable in relevant Principles of Good Laboratory Practice. Provide study personnel with access to study plans and SOPs applicable to their involvement, with a responsibility to follow instructions and document any deviations. Emphasize the responsibility of all study personnel to promptly and accurately record raw data, comply with Good Laboratory Practice principles, and exercise health precautions to safeguard the integrity of the study.

我們正在尋找一位富有遠見、經驗豐富的研發長，帶領公司生物醫學/生物技術研發團隊，推動創新產品從概念到市場的開發。研發長將負責制定並執行公司科研策略，確保產品符合科學、商業及法規要求，並與跨部門團隊合作，實現公司的長期願景。 專業技能 • 研發管理：熟悉完整產品研發週期（臨床前研究、臨床試驗、產品驗證），能有效管理資源與專案進度。 • 法規知識：熟悉國際及本地法規（如 FDA、EMA、TFDA），確保研發符合 GCP 及相關合規標準。 • 技術專長：精通公司產品相關的核心技術，例如 CRISPR、mRNA 技術、抗體藥物、醫療器械設計等。 • 數據分析：具備解讀複雜科學數據的能力，熟悉生物資訊或統計工具者優先。 領導與軟技能 • 策略規劃：能制定與公司商業目標一致的長期研發策略，並預測行業趨勢。 • 團隊領導：具備激勵和管理跨功能團隊的能力，促進科學家、工程師與臨床研究人員的協作。 • 溝通能力：能有效向非科學背景的利益相關者（如投資者、董事會）解釋複雜技術概念。 • 創新與問題解決：展現創造性思維，願意探索高風險、高回報的研發方向。 商業與市場洞察 • 理解生醫市場的競爭格局與客戶需求，能將科研成果轉化為具商業價值的產品。 • 具備與投資者、合作夥伴或政府機構溝通的經驗，協助爭取研發資金或補助。

1. 細胞實驗及動物實驗操作(細胞培養、藥物測試、初代細胞分離與分化、採血、管餵、靜 脈注射等小鼠實驗操作技術)。 2. 分子生物及免疫螢光染色相關實驗操作(ELISA .Flow cytometry. IHC-F. ICC/IF, Western blot等)。 3. Exosome分離及分析。 4. 數據分析及報告撰寫。 5. 文獻蒐集及整理。 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。

• 操作基因檢測相關實驗 • 執行次世代定序（NGS）平台操作，進行樣本前處理、文庫建置與定序流程 • 進行生物資訊分析與數據整理，提供後續臨床風險評估 • 確保實驗流程符合實驗室品質系統標準（如ISO 15189） • 配合跨部門溝通與資料整合 • 撰寫與維護SOP文件，協助提升實驗室作業效率與準確度 • 支援主管交辦之其他技術開發或專案任務

1. 執行ELISA相關的藥物動力學(PK)、免疫原性(immunogenicity)分析、Biomarker分析 2. 方法開發與方法確效研究。 3. 執行臨床試驗檢體、動物檢體前處理與分析 4. 依循計畫書與SOPs操作及執行研究，並符合GLP規範的要求。 5. 撰寫GLP計畫書、報告、分析方法SOPs。 6. 擔任實驗室儀器或職務管理人。

- Responsible for all aspects of site management and monitoring of clinical trials - Manage interactions with all partners (investigators, site teams, internal company departments, external contractors, etc.) to facilitate successful conduct of clinical projects. - Support clinical research activities as assigned by the supervisor. - Build strong professional relationships with investigators, site staffs and internal/ external service providers. - Conduct initiation visits, monitoring visits and site closure visits in collaboration with the clinical project team. - Maintain the Trial Master File. - Prepare and negotiate site clinical trial agreements and manage clinical site budget and expenses. - Preparation of regulatory and ethics submission dossiers. - Ensure protocol-related safety reporting compliance and address and drive issue resolution. - Monitor site recruitment and establish/discuss action plans in close collaboration with the Clinical Project Manager. - Develop and conduct training for investigators and site staffs in the protocol, product and study-specific procedures. - Coordinate activities to ensure compliance with protocol, GCP, overall clinical objectives as well as company policies and SOP. - Manage trial product inventory, shipment and storage, and ensure accountability and traceability. - Ensure that imaging and/ or laboratory samples are collected, handled and shipped according to protocol requirements. - Ensure that safety reporting of adverse events is completed within required time periods. - Manage external vendor services for assigned clinical sites. - Identify issues which affect clinical trial progress and quality, and develop solutions and/ or take action to resolve/ prevent them. - Deliver projects according to expected targets, budgets and quality standards. - Monitor and report to clinical management teams on clinical trial progress, performance and plan, including subject recruitment and retention, monitoring activities, data completeness and quality, and site compliance. - Assist in the organization and conduct of internal and external stakeholder meetings, as required. - Set up, maintain and update clinical research activities and initiatives in the system.

工作地點：臺大醫院智慧醫療中心 職缺性質：兼職 1. 臺大醫院工作證申請: 於正式收案至少1.5個月前向台大臨床試驗中心申請臨床研究工作證（紅卡）暨研究案授權，確保取得工作證 2. 受試者招募: 試驗細節說明、協助受試者同意書簽署、依同意書資訊key-in受試者性別/年齡、給予受試者禮券(禮券保管) 3. NW500拍攝: 接受NW500拍攝訓練、拍攝眼底影像(一人2張)、每周整理NW500儲存的影像，提供給Sponsor 4. 配合Sponsor on-site monitoring活動 5. 醫院端庶務協助: 請PI/sub-I簽名相關文件、試驗文件管理與掃描歸檔、計畫經費核銷、協助儀器進出場相關事宜

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.

• Proactively manage project level operational aspects including management of trial timeline, budget, resources, and vendors. • Provide efficient updates on trial progress to the Clinical Director and/or Senior management team, with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation. • Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets. • Ensure effective project plans are in place and operational for each trial and work proactively with the internal team/vendors to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements. • Ensure potential study risks are escalated to the attention of the Clinical Director when appropriate. • Chair internal working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner. • Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner with internal team/CRO. • Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team. • Review and approve vendor invoices to ensure payments occur in a timely manner • Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements. • Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the internal team/vendors regarding TMF filing, maintenance and archival procedure • Effectively provide support to CRO/internal team/vendors in the conduct of the trials • Support to development and review of SOPs and workflow

1.獨立執行藥劑配方設計。 2.分析方法開發。 3.撰寫SOP與其他技術文件。 4.工業製程放大。 5.創新產出專利。

1. 和小組成員共同合作，負責執行抗體/蛋白藥物前端研發工作(包含但不限於抗原製備、抗體篩選、plasmids構建和抽取、細胞培養、體外功能實驗等工作) 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. 協助SOP、實驗記錄及報告等體系的撰寫及管理 4. 負責實驗室相關儀器與環境的使用及維護 5. 協助主管完成各項交辦工作和任務

MAKE RESEARCH HAPPEN《陪科學家不斷前進，為科學研究提供最佳解決方案，為科學創造無限價值》 ✔ 技術服務助理研究員工作內容 <本職務為擴編需求> 1. 執行及管理技術服務案件 2. 負責TOOLS自有品牌產品生產 3. 須熟悉分子生物技術、質體萃取、免疫染色、組織切片、操作顯微鏡 ★ 基本條件 (1) 分子生物學專長 (2) 自律且具備團隊合作意願 + 加分條件 1. 熟悉組織切片、免疫染色、ELISA、質體萃取者佳