「藥品製劑處-藥品製劑組-資深專案經理」的相似工作

1. Responsibilities and Job Requirements: *Responsible for reviewing Finished NDA and ANDA CMC documents to ensure compliance with international and regional regulatory standards. *Coordinate with internal teams to ensure product compliance and registration progress. *Provide technical and regulatory expertise, assisting in resolving product development and regulatory issues. *Familiar with regulatory requirements in various countries to ensure submitted documents adhere to local regulations. *Participate in cross-functional collaboration during the review process to ensure effective project execution. *Manage the team, provide guidance and professional training, ensuring optimal team performance. 2. Qualifications and Skills Required: *Bachelor's degree or above in Pharmacy, Chemistry, or a related field. *Minimum of 5 years of experience in drug review. *Familiarity with international drug regulatory requirements, including ICH, FDA, EMA, etc. *Excellent communication and leadership skills, with the ability to effectively manage teams and coordinate cooperation. *Strong problem-solving and decision-making abilities, capable of addressing complex regulatory challenges. *Fluent spoken and written English communication skills. 1. 職責與職位要求： *負責審查NDA/ ANDA製劑相關文件，確保其符合國際和地區監管標準 *與內部團隊協調，確保產品的合規性和註冊進度 *提供技術和法規方面的專業建議，協助解決產品開發和監管問題 *熟悉各國監管要求，確保提交的文件遵守各地的法規 *參與審查過程中的跨部門協作，確保項目的有效執行 *管理團隊，提供指導和專業培訓，確保成員發揮最佳水平 2. 資格與技能要求： *擁有藥學、化學或相關領域的學士或以上學位 *至少有5年以上的藥品審查經驗 *熟悉國際藥品監管要求，包括ICH、FDA、EMA等 *優秀的溝通和領導能力，能夠有效管理團隊和協調合作 *強大的問題解決和決策能力，能夠應對複雜的監管挑戰 *流利的英語口語和書面表達能力

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.爭取/執行政府計畫 2.管理藥品製劑研發處內部專案,行政事務. 3.協助研發技術專業推廣 4.與國內外藥廠爭取合作.

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

◖為什麼你該加入台美檢驗Superlab◗ 我們是全國唯一橫跨醫學、化學及生物相關領域的檢驗科技公司。 擁有最齊全的設備、最先進儀器、最頂尖創新檢驗技術的全方位實驗室，服務項目包含一般食品、藥品、中藥、健康食品、化妝品、環境水質、化學品、紡織品、奈米產品、飲用水、醫療器材、生醫材料等。 邀請你和我們一起為消費大眾的衛生安全把關，並確保每一階段都能達到法律規範和個人期望的高標準。 ◖你將在團隊參與◗ 1. 健康食品/醫療器材/藥品臨床前試驗研究主持人 2. 臨床前試驗規劃開發、試驗流程優化、數據合理性分析 3. 實驗室GLP品質系統維運與優化 ◖我們期待優秀的☞研究主持人☜具備這樣的能力◗ 1. 具三年以上以上細胞或病毒實驗經驗 2. 具執行多年期計畫或專案經驗 ◖如果你有這樣的條件，那就太好了◗ 1. 有ISO/IEC 17025 測試實驗室管理經驗尤佳 2. 有細胞治療或再生醫療相關產業經驗尤佳

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.滿足日常藥物研發需求-取得和提取動物組織，使用放射性標記配體執行受體結合實驗* （*我們實驗室採用高於法規規定的防護策略和徹底的輻射防護訓練） 2.科學創新和重塑** - 根據觀察和研究證據分析和完善工作流程 3.發現新的可能性** - 設計、測試和驗證新的檢測方法和平台 4.建立關係和溝通網絡 - 建立良好的人際溝通能力並與團隊成員合作 5.其他分配的任務 - 設備和實驗室環境的日常維護 ** 碩士學位候選人必須具備 1. Fulfil daily drug discovery demand - acquire and extract animal tissue, execute receptor binding assays with radio-labeled ligands* (*A higher-than-regulation protecting strategy and a thorough radiation protection training are applied in our laboratory) 2. Scientific innovation and reinvention** - analyze and refine the workflow based on observations and research evidences 3. Discover new possibilities** – design, test, and validate new assays and platforms 4. Building relationships and communication network- establish good interpersonal skills and collaborate with team members 5. Other assigned tasks – routine maintenance of equipment and laboratory environment ** Obligatory for Master’s degree candidates

協助醫學專業人士或藥廠優化研究設計，並以英文撰寫與修改學術文件及研究計畫，確保內容的專業性與準確性。 與醫療機構及研究單位建立長期穩健的合作關係，依照客戶情況提供專業建議，解讀臨床數據，搜尋學術文獻找出臨床研究的價值，協助解決研究過程中的挑戰，以提升研究品質與學術產出價值。

1.藥品查驗登記申辦輔導，含檢核申請文件、臨床試驗法規遵循、應對查驗、缺件補件及後續查詢事宜。 2.執行政府專案法規研究(國內外)，及負責專案計畫管考。 3.追蹤並分析國內外藥品法規最新動態，並提供相關法規諮詢。

此職務是連結研發與 GMP 生產的重要橋樑。您將不僅負責製程優化與放大，還需執行毒理批次 (Tox material) 生產，並承擔技術轉移 (Tech Transfer) 至 GMP 的任務。此角色同時涵蓋 MSAT (Manufacturing Science and Technology) 的核心功能，確保製程具備穩健性、可重現性與 GMP 導入準備。 1) Process Operations and Scale-Up - Manage and execute process operations ranging from 5 to 200 liters. - Ensure consistency, scalability, and reproducibility of upstream processes. 2) Tox Material Production - Lead the production of non-GMP toxicology batches to support preclinical studies. - Ensure materials meet quality standards and development timelines. 3) Process Optimization and DOE - Design and conduct experiments (DOE) to optimize upstream workflows. - Continuously improve existing processes for better yield, efficiency, and robustness. 4) Tech Transfer to CDMO - Prepare documentation and transfer processes to external CDMO partners. - Provide MSAT support to ensure smooth transition into GMP environments. 5) Cross-Functional Collaboration - Work closely with downstream, analytical, and quality teams to support integrated project needs. - Effectively communicate results and process improvements through reports and presentations. 6) Laboratory and Project Support - Assist in laboratory material management to ensure smooth operations. - Support other functional teams as needed to meet project goals.

主要職務: 1. New project evaluation, perform literature study 2. Pharmacology and PK/PD data interpretation 3. Assist nonclinical & clinical CRO management 4. Project management for new drug development 詳細職務內容: 1. In-depth study on marketed drugs and their target indications, consider MOA, PK/PD profile, formulation design, brainstorming for new project ideas. 2. Various literature search and information gathering per supervisor’s request 3. Assist in nonclinical study design. 4. Assist in CRO contracting and follow up study execution. 5. Data processing & provide scientific interpretation. 6. Serve as PM role in various projects, taking meeting minutes, tracking development progress

Pythia Biotech is a Taiwan-based startup dedicated to accelerating cancer drug development, immunotherapy, and precision medicine through Organ-on-a-Chip (OoC) technologies. We are expanding our team and seeking a Head of R&D to lead research, drive innovation, and advance translational applications. This is a rare opportunity to join a fast-growing startup, work alongside a world-class advisory team, and take on a pivotal leadership role as the company scales. Job Responsibilities •Develop and execute R&D strategies to support oncology and immunotherapy research. •Lead the development and validation of the TME-Chip platform. •Manage project timelines and resources to ensure successful delivery. •Support and communicate with partners to integrate resources and promote R&D progress. •Ensure that R&D complies with relevant laws, regulations and standards. •Prepare investment presentations, represent the company at academic and industry conferences to raise visibility. Qualifications •Ph.D. in Oncology, Immunology, Biomedical Engineering, Pharmacology, or a related field. •Minimum 2 years of experience in biotech or pharmaceutical R&D; prior leadership experience is a plus. •Familiarity with tumor biology, immuno-oncology, organoids, or Organ-on-a-Chip-related technologies. •Experience in cross-functional collaboration and project delivery in dynamic or startup environments. • Strong communication skills in both Mandarin and English; able to represent the company externally.

1. A M.S. or Ph.D. degree in Chemistry or Pharmacy with no less than two years of industry R&D experiences. 2. Strong background in analytical/medicinal/or organic chemistry. 3. Well-experienced in analytical method development and validation. 4. Hands-on experience in the development and characterization of intermediate of active pharmaceutical ingredient , formulation development and/or PK study analysis. 5. Excellent communication skills and good team spirit. 6.Looking for who is willing to take the challenge to be a pioneer combination chemist for novel drug discovery of CNS disorder.

(合作廠商: 生華生物科技股份有限公司) 公司以臨床開發為主、基礎研究為輔，致力於小分子抗癌新藥的研發，專注在「市場首見(first in class)」抗癌新藥開發，在資金、營運、智財、藥物合成、藥物製劑、動物試驗及臨床試驗等等管理之經驗豐富，隨著臨床試驗由一期進入第二期及三期，以及開發新的適應症應用，整合完備的資源，能提供合宜的培訓需求。 JD職缺說明: 職稱: 臨床前研究實習 • 具有規劃、管理及執行臨床前試驗/或是臨床試驗之能力。 • 具備基本分子生物實驗技術。 • 了解如何設計良好及合適的動物試驗，以充分了解試驗藥物的潛在風險和益處。

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。

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

1. 藥品分析方法開發。 2. 專案計畫規劃與執行。 3. 廠商委託試驗規劃與執行。 4. 文獻、法規及研發資料查詢。 5. 主管交辦事項。

1. 提供技術支援服務(含客戶端技術說明、試劑或儀器展示) 2. 售後服務處理與追蹤(含教育訓練、產品抱怨處理) 3. 相關法規蒐集與整理 4. 支援產品行銷活動策畫與執行 5. 協助公司業務推廣 6. 主管交辦事項

• 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. Review and provide the technical recommendations for CMC documentation and Common Technical Document(CTD) dossier from a regulatory perspective. 2. Interpretation and Handling the regulatory technical query’s responses that were asked by Client and Authority during the due diligence or submission deficiency phase and provide the action plan or solution and scientific justification. 3. Responsible for evaluating the registration feasibility and mapping the global registration strategy for assigned new R&D products. 4. Cooperate and teamwork with R&D, technical, and RA PM on new R&D project technical challenges and complete the dossier till product approval. 5. Responsible for regulatory registration for export products and make sure all the documents are meet the authority's requirements. 6. Responsible for deficiency response preparation to ensure our response meets the authority’s requirements. 7. Accurately follow the update of the registration regulation, and provide the regulation update to the team and training.