「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.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.

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.

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

工作內容 (1) 開發生醫訊號演算法與生理訊號處理, ECG, SP02, Blood Pressure, R/R...etc (2) 預測模型設計與開發 (3) 演算法API設計與開發 (4) 協助臨床研究與醫療器材技術文件撰寫 工作說明 : 1. 開發新演算法或改進現有演算法，用於血壓及血氧及其他生理訊號。 2. 分析臨床數據庫或生物傳感器收集的（通常是連續動態的）數據。 3. 生醫訊號演算法與生理訊號處理 4. 雜訊抑制 (noise reduction) 及萃取 (extraction)演算法 5. 熟悉開發工具熟悉開發工具C/C++, Python, MATLABC/C++, Python, MATLAB等專業模擬軟體等專業模擬軟體

Please do submit English resume to our company website. https://fa-euzi-saasfaprod1.fa.ocs.oraclecloud.com:443/hcmUI/CandidateExperience/en/job/1488?utm_medium=jobboard General Responsibilities: Manage staff in accordance with organization's policies and applicable regulations, including without limitation: planning, assigning, and directing work; managing performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; acting as a coach and mentor for subordinates as they develop in their role. Participate in the selection and onboarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs. Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable. Maintain lab daily operation. Ensure the quality and timely of lab deliverable. Perform the tasks assigned by line manager. Refer to additional GLP/GCP Regulation Required Responsibilities while involved in GLP organization. As the member of test facility/site management. Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc. GLP/GCP Regulations Required Responsibilities (if needed): Lab Manager Maintain an internal responsibility chart which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by the Principles of Good Laboratory Practice. Ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study. Ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual. Ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions. Ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the Study Director before the study is initiated. Replacement of a Study Director should be done according to established procedures, and should be documented. Ensure, in the event of a multi-site study, that, if needed, a Principal Investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a Principal Investigator should be done according to established procedures, and should be documented. Ensure documented approval of the study plan by the Study Director. Ensure that the Study Director has made the approved study plan available to the Quality Assurance personnel. Ensure the maintenance of a master schedule. Ensure that test facility supplies meet requirements appropriate to their use in a study. Ensure for a multi-site study that clear lines of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel. Ensure that test and reference items are appropriately characterized. Ensure that appropriate and technically valid Standard Operating Procedures are established and followed, and approve all original and revised Standard Operating Procedures. If necessary, function as Study Director for specific study, in this case, he/she must not have the responsibility of test facility/site management role in the study.

依據團隊規劃之研發專案方向執行以下工作: 1. 新產品規劃與探索 2. 新產品開發專案管理與執行 3. 細胞/生化實驗設計與執行 4. 動物試驗方法開發與討論 5. 專利答辯及回覆方案建議 6. 協助產品申請之生物藥理技術回覆與方案建議 條件: 1. 相關科系博士畢，或具備7年以上相關工作經驗 2. 具備實驗設計、規劃及執行能力 3. 擁有豐富的細胞培養經驗與知識 4. 執行分子生物學（q-RT-PCR、RNA seq、ELISA 或 WB）的經驗 5. 有免疫染色（流式細胞儀、IHC或IF）相關經驗

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。