「研發課長/副課長-湖口」的相似工作

1. 配方研究試製 2. 製程技術開發與轉移 3. 協助量產與製程優化 4. 新產品開發評估 5. 查驗登記資料撰寫 6. 實驗室管理。 歡迎 所有求職者

We are seeking a highly motivated and innovative R&D Scientist to join our pharmaceutical development team. The successful candidate will contribute to the design, formulation, development, and optimization of drug products, with a focus on quality, scalability, and regulatory compliance. This role offers the opportunity to work in a collaborative environment with cross-functional teams including Regulatory, Analytical/QC, Quality, Manufacturing, and Business Development. 1.Conduct research and development of new drug formulations for Global Regulated markets (Nasal – Solution, Spray, DPI, pMDI etc.) 2.Follow Quality by Design to plan & execute lab-scale experiments, stability studies, and process development activities including DOE. 3.Responsible for managing monographs, validated excel sheets, approved reports (paper and electronic), notebooks and document archival. 4.Develop & optimize manufacturing processes in compliance with cGMP requirements. 5.Participate in Technology transfer to manufacture pilot, scale up, submission & commercial batches. 6.Prepare technical documents, as per cGMP & ICH for execution and manufacturing including batch records, protocols and reports. 7.Prepare regulatory submission documents as pe ICH including chemistry manufacturing & controls (CMC), product development report, overall quality summary (OQS) etc. 8.Execute CCR, deviation investigation, CAPA, LIR, SOP preparation, internal and support GMP inspection. 9.Stay updated with scientific & global regulatory advancements and ensure knowledge sharing with co-workers. 10.Collaborate with cross-functional teams on project timelines and deliverables

1. Establish a stability database for annual product reviews and product attribute statistics. 2. Stability program management 3. Supplier qualification, internal audits 4. Monitor and implement cross-contamination prevention measures 5. Cleaning validation and verification management 6. Assign as requested by supervisor. 該員工主要負責APR (stability section), Stability program management, shipping study

1.協助實驗室工作安排/經營管理與技術支援 2.撰寫專案研究計畫書及報告(中/英文) 3.協助或輔導客戶在專業技術上說明,討論與溝通

工作內容： (1) ELISA檢測抗體與試劑開發 (2) 磁珠Antibody Coating (3) 磁珠based ELISA檢測試劑開發

1.協助醫藥配方設計與開發 2.進行配方與產品之物化性檢測及規格確立 3.進行醫藥原料採購及委託廠商洽談 4.完成微針產品開發所需之檢測分析 5.實驗室設備操作(HPLC、ELISA) 6.其他主管交辦事項

Key responsibilities include the following, but are not limited to: 1. Generate Quotations: - Coordinate CDA/agreements execution - Coordinate internally to gather information required for quotation - Provide quotations/project proposal to Client and follow-ups 2. Client Communication Management - Serves as a central hub of internal/external communications with existing clients/third parties for project and product changes - Serves as a central hub of internal/external communications with potential new clients /third parties to provide proposal to meet their needs and to enhance company business opportunities - Schedule and arrange project meetings and task assignments, communicate expectations and record meeting minutes 3. Project Planning: - Establishes project charter and plan to define project scope and timeline - Assign tasks and perform follow-ups to ensure timely deliverables - Identify potential issues and risks, and solutions. 4. Project Execution and Delivery: - Drive project activity execution to meet goals/objectives and the agreed plan without compromising project deliverables or relationships - Work with Subject matter experts to propose solutions on a variety of issues with low to moderate complexity and changes - Coordinate Client Budget management including invoice management to client. - Leverage robust project management skills and co-work with project managers to drive key decisions and milestones according to the endorsed plans, timelines, costs, and quality parameters 5. Perform other PMO-related duties/tasks as assigned by Management 工作內容 1. 開發委託開發/代工(CDMO)業務、準備委託案報價單及合約簽訂 2. 負責委託開發/代工(CDMO)專案進度追蹤(業務端)與文件管理、客戶端聯繫窗口 3. 協調廠內PM與客戶溝通事宜 4. 委託開發/代工(CDMO)業務監督與管理：各專案進度掌握與彙整、收款進度管理、BD 專案人員管理

1. 執行產品生產製造或原料,成品品質檢測 2.生產/檢驗設備操作與工作區域日常維護 3.紀錄生產及品管數據,確保符合公司內部SOP規範與法規要求 4.執行環境監控並遵守無菌操作規範 5.協助異常狀況處理,並參與程序書改善與優化

1. R&D x Innovation: 參與高階分析儀器與自動化設備的研發、測試與驗證，打造下一代尖端產品。 2. Deep Dive into Instruments: 直接上手 GC、ICP-MS、ICP-OES 等分析設備，從實驗數據中挖掘最佳解決方案。 3. End-to-End Project Involvement: 從概念設計、樣機試作到產品導入，一路跟進並完成專案任務。 4. Cross-Team Collaboration: 與研發主管、生產工程及品管團隊合作，解決現場疑難雜症。 5. Customer-Centric Testing: 協助安裝、驗收與技術支援，收集第一手回饋，優化產品設計。 若績效表現優秀,可獨立完成專案,年薪可破百萬

1. HPLC、GC分析方法開發 2. 安定性試驗設計及報告撰寫 3. 撰寫品質文件 4. 執行ISO與GMP相關業務 5. 協助原料、半成品、成品檢驗業務 6. 協助實驗室校正與維護作業

1.規劃並推進研發專案。 2.負責專案進度追蹤、資源協調與成果報告。 3.協助專利申請與法規註冊(INCI、小綠人等)。 4.推動學研合作，執行功效試驗與技術驗證。 5.支援工廠化與量產，確保技術落地商品化。 6.跨部門溝通，協助將研發成果轉化為產品應用。 7.主管交辦事項，

1. 負責藥品研究開發及相關作業執行，有法規單位送件經驗者佳。 2. 內部跨部門工作協調及外部廠商溝通業務，有CRO、CMO經驗佳。 3. 具獨立完成問題分析及解決能力。 4. 具藥廠研發經驗或新藥開發經驗。 5. 主管交辦事項。 6. 重視團隊合作，具良好溝通協調能力。

1. 具專案執行經驗 2. 文獻搜尋、簡報整理、研究計畫撰寫 3. 具細胞培養/疾病或藥物開發經驗 4. 實驗室環境、設備及耗材管理維護 5. 其他主管交辦事項

1.細胞與再生醫學相關研發專案評估與執行 2.實驗設計、執行、結果分析與紀錄彙整 3.文獻資料蒐集彙整 4.協助建立研發相關標準作業程序 5.協助臨床試驗專案相關事務 6.研發部行政庶務

1. 臨床試驗的規劃與執行，包括臨床試驗流程監控、Phase 1 臨床數據分析、Phase 1/2 & Phase 2 試驗設計所需之背景資料收集與解讀。 2. 規劃並推進 長效針劑產品 BE study，包含CRO選擇、資源配置與時程管控，確保與整體 研發計畫一致。 3. 進行臨床數據與 藥理/藥代（PK/PD）分析 之審查與解讀，並撰寫醫學與科學報告，以支 持法規申請與內部決策。 4. 協助安全性監測（SAE/AE 評估、signal detection）與真實世界/背景數據分析，確保受 試者保護與醫學合規性。

1. - Analytical Method Development: Perform analytical method development, formulation screening, finished product testing, stability study, dissolution testing, RLD reverse engineering, technical transfer, and laboratory-related work during the development stage. Support NDA and ANDA submission. Support the complete drug development lifecycle management. 分析方法開發- 主要職責包括以下內容: 在開發階段進行分析方法開發、配方篩選、成品測試、安定性研究、溶出度測試、原廠藥逆向工程、技術轉移和實驗室相關工作。協助NDA和ANDA查驗登記。協助完整的藥物開發生命週期管理。 - Method Validation: Perform analytical method validation, analytical method verification for drug substances, finished products, cleaning analytical methods. Conduct method transfer. Support raw material and stability analysis. Support NDA and ANDA submission. 方法驗證: 執行原料藥、成品、清潔分析方法的分析方法確校、分析方法確認。執行方法轉移。協助原料和安定性分析。協助NDA和ANDA查驗登記。 2. Train, lead, mentor and supervise team members in day-to-day laboratory operations. Support relevant departments and customers to complete projects on time. Ensure all activities and analysis comply with GMP, correct procedures, policies, and health and safety regulations. 在日常實驗室操作中，訓練、領導並監督團隊成員。協助相關部門和客戶按時完成專案。確保所有活動和分析均符合藥品良好製造規範、正確的程序、政策以及健康和安全法規。 3. Responsible and accountable for the quality and timeliness of the project deliverables, resource management, technical support for team members, and communication of the progress to the senior management. 對專案交付的品質和及時性，資源管理，團隊成員的技術協助以及與高級管理階層的進度溝通負責並承擔責任。 4. Manage and lead day-to-day operations with the team, including prioritization, task assignment, workload management, and risk management. 與團隊一起管理和領導日常運作，包括優先順序調整、任務分配、工作負荷管理和風險管理。 5. Adequately utilize and maintain analytical instruments/equipment. Diagnose and identify solutions to resolve analytical instrument issues. Perform calibration, qualification, and preventive maintenance. Support for procurement and qualification of new analytical instruments/software. 充分利用和維護分析儀器/設備。診斷和識別解決方案以解決分析儀器問題。執行校正、驗證和預防性維護。協助採購和驗證新的分析儀器/軟體。 6. Review the documents, electronic records. Prepare analytical protocols and reports, and CMC documents. Monitor data trending and support for deficiency letter response. Ensure good documentation practices and data integrity. 審查文件、電子記錄。準備分析計畫書和報告以及化學製造管制文件。監控數據趨勢並協助缺失信件回覆。確保優良文件化規範和數據完整性。 7. Lead and support CCR, deviation investigation, CAPA, LIR, SOP preparation, internal and GMP inspection。 協助變更管制、偏差調查、矯正預防措施、實驗室調查報告、標準操作程序準備、稽核。 8. Responsible for managing monographs, validated excel sheets, approved reports (paper and electronic), notebooks, and scan copies. 負責管理檢規、經過驗證的Excel工作表、已批准的報告（紙質和電子版）、筆記本和掃描副本。 9. Support assigned responsibilities to maintain GMP compliance of the chemical laboratory, as applicable. 如適用，依據分配責任，維持化學實驗室運作皆符合藥品良好製造規範。 10. Transfer analytical method to Quality control, QP sites, and other receiving laboratories. 轉移分析方法到品質管制，QP所在地和其他接收實驗室。 11. Lead and guide laboratory management work, e.g., reference/working standard management, instrument management, laboratory area cleaning, reagents and solvents, and other supporting systems. 領導和指導實驗室管理工作，例如參考/工作標準管理、儀器管理、實驗室區域清潔、試劑和溶劑以及其他支援系統。 12. Stay informed with the latest industry trends, techniques, and best practices. 隨時了解最新的行業趨勢、技術和最佳實踐。 13. Perform literature search, patent landscape review, regulation comparison, review guidelines, read the pharmacopeias, technical document to understand the latest knowledge of the pharmaceutical industry. 進行文獻檢索、專利態勢審查、法規比較、審查指南、閱讀藥典和技術文檔，以了解製藥行業的最新知識。 14. Ensure the laboratory Capex management. Review & approval 0f URS, DQ, IQ, OQ, PQ & Vendor qualification. 確保實驗室資本支出管理。 審閱和批准 URS、DQ、IQ、OQ、PQ 和供應商資格。 15. Promptly complete work and tasks assigned by the supervisor 及時完成上級下達的工作和任務。 16. Motivate and empower team members. Conduct performance review and appraisal for team members. 激勵和授權團隊成員。執行績效審查和評價。 17. Engage with the team and manage the conflict, making sure individual employees into a cohesive team and complete the project milestone. 與團隊互動並管理衝突，確保員工個人成為一個有凝聚力的團隊並完成項目里程碑。

1. Process review 2. Process development & optimization 3. Scale up 4. Technology transfer to production 5. Impurity profile establishment 6. Reference standard preparation 7. Product specification establishment 8. Project evaluation and management 9. trouble-shooting 10. relevant documentation (SOP document, derivation, OOS, DMF filling )

1. Manage the Lotus disposition process including ◆ Review of GMP Manufacturing Documents including Batch Records, Investigations, Deviations/CAPA, Analytical Testing Documents, and Certificates of Analysis. ◆ Managing timelines and resources to ensure the disposition of material in accordance with Lotus' SOPs and within agreed timelines. 2. Provides leadership to assigned staff by performing the following: ◆ Leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals. ◆ Building effective teams that apply their diverse skills and perspectives to achieve common goals. ◆ Driving engagement and creating a climate where staff is motivated to do their best. 3. Oversees, manages, and ensures the successful day-to-day operations of Quality Assurance-Operation departments for the company. 4. Ensure the QA successfully performs batch disposition activities to meet specified timelines. 5. Ensure the timely review of batch records, SOPs, investigations, corrective actions, change controls, technical documents, and adherence to Quality Agreements. 6. Establish meaningful goals and metrics for groups in conjunction with the Site Head of Quality, and manage the performance to those goals. 7. Interfacing with customers to ensure clear and open communication is maintained when intermediate levels of escalation are required by the QA staff. 8. Communicating priorities and distributing work assignments to direct reports. Ensuring that all work performed by Staff is performed safely, with quality, and in a timely, compliant manner. 9. Leading and ensuring the group is leading and participating in continuous improvement projects throughout the group and the facility/operational portions of the organization. This includes all QA systems and processes as well as those on the shopfloor through the A on the Floor function. 10. Leading, managing, and/or participating in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies, and regulations. Ensuring the group is doing the same as required. 11. Providing feedback and coaching in technical skill development, job performance, and career growth, and taking necessary disciplinary actions if necessary. Advocating for employees when required. 12. Ensuring the quality and compliant production and disposition of batches and the quality and compliant operation of all systems throughout the facility in accordance with schedule requirements. 13. GMP Supplier Oversight: ◆ Oversight of the GMP Vendor Audit Schedule. Ensuring Vendor and Auditor availability (internal/external/consultant) and confirming audit dates with both Auditors and Vendors. ◆ Review supplier audit reports, ensuring they meet Lotus QA standards and are compliant with Lotus SOPs. ◆ Submitting Observation reports to vendors, communicating response timelines, and tracking them to ensure timely responses. ◆ Review vendor audit responses and manage the review/editing cycle until responses are acceptable. ◆ Requesting documented evidence of closure when necessary and filing electronically and in hard copy. ◆ Updating CAPA trackers. 14. Quality Assurance Management: ◆ Documentation control (master batch record, specification & method). ◆ Batch record review and product disposition. ◆ Investigations, complaints, deviations, CAPAs, APRs. ◆ Production support. ◆ APRs, GMP training, and SOP review. ◆ Validation/qualification documentation review & approval. ◆ QA Operations – inspection, sampling, and review of incoming materials, perform AQL inspections, support, and drive compliance throughout the site. ◆ Departmental budget development and compliance. ◆ Regulatory and customer inspections management. ◆ Quality management review – quality board and related KPIs.

1. 製造部門相關SOP建立 2. 製造部儀器設備定期維護保養及環境維持 3. 協助部門相關製程優化 4. 配合生產排程，依製程管制標準書及SOP執行符合廠內生產規範之細胞培養製程相關作業 5. 其他支援性工作或主管交辦事項

Principle Roles & Responsibilities 1.物理及化學分析設備的規格書撰寫,採購,驗證及操作文件撰寫 2.物理及化學分析實驗室管理及相關管理SOP撰寫 3.原料/生產產品檢驗相關分析方法的技轉,確效,及操作SOP撰寫及執行 4.參與物理及化學分析實驗室操作人員在職訓練 5.制定並執行穩定性測試計劃，以及分析方法的驗證與確效。 6.評估穩定性趨勢與分析數據。 7.負責物理和化學分析相關設備的校準與預防性維護活動。 8.審核所有物理和化學測試的檢測結果。 9.解決原料、成品、生產過程研究及驗證中的物理與化學測試問題，進行故障排除和解決。 10.向實驗室主管或代理人報告設備故障及安排維修 11.負責實驗室試劑和消耗品的充足庫存，透過監控再訂購水平並及時通知。 12.負責準確的記錄分析數據與結果於記錄本、產品規格與品質保證報告，以及實驗室分析表單，並以趨勢監測的角度記錄結果。 13.負責調查物理與化學實驗室的超出規格（OOS）與偏差事件。 14.以持續改進的態度執行工作，以達成既定的關鍵績效指標（KPI）。 15.完成主管或公司指派的其他任務。 Secondary Responsibilities 1.協助準備分析所需的試劑，並按照標準書面方法，在規定的時間間隔內對容量分析溶液進行標定。 2.參與產品、原料、包裝材料及穩定性樣品物理與化學相關分析。 3.協助分析人員執行實驗室設備的校準與預防性維護活動。 4.參與分析方法技轉程序。 5.負責確認內部開發的分析試劑的有效期限，並確認在其容器或文件上有標註到期日。 6.根據標準安全規範處理和處置危險材料，如砷、氰化物和濃酸。 7.按照標準預定程序，記錄受管制的有毒化學品的使用與處置情況。