【職位介紹】 歡迎加入我們的前臨床團隊，開發針對HPV及其他適應症的DNA疫苗。您將有機會參與內部專案，並與製藥和生技合作夥伴合作。 工作包括開發檢測方法、進行生物分析和評估疫苗候選品。也需要與團隊內部及其他部門協作，準確報告您的工作並參與專案會議。 我們尋找對藥物開發充滿熱情的人員。您將有機會評估、提出、執行和管理新藥專案，專注於DNA、RNA和蛋白質基礎藥物，進行動物研究和免疫學分析。 【主要職責】 - 協助評估、提出、執行和管理新藥開發專案。 - 進行DNA、RNA和蛋白質基礎藥物的品質分析。 - 執行動物療效研究和免疫學分析。 - 撰寫實驗計劃和結果報告。 - 收集和整理科學文獻及產業資訊，並準備相關報告。 - 協助實驗室相關事務和其他交辦工作。 【資格和經驗】 - 超過一年在生技、製藥或學術環境中的新藥開發經驗者優先。 - 生物學、化學、藥理學、毒理學或相關領域的學士或碩士學位。 - 具有體內腫瘤模型的實操經驗，包括腫瘤測量、治療藥物給予（IV、SC、IP）和血液採集。 - 具備生物製劑功能分析經驗。 - 良好的多任務處理、組織和時間管理技能。 - 具備分析思維和實驗設計理解能力。 - 良好的溝通和人際交往能力。 - 英語熟練者優先。

Cosmetic Research Chemist - Personal Care Formulation Key Responsibilities: •Project Management: Independently manage projects and assignments from inception to completion. Utilize excellent time management and prioritization skills to handle multiple projects and meet deadlines efficiently. •Analytical Procedure Development: Lead and support the design and execution of analytical methods for evaluating active ingredients and formulation excipients across personal care products. •Method Development & Validation: Develop, validate, and optimize analytical methods to collect, interpret, and report essential data that drives product development and ensures compliance with global regulatory standards. •Process Improvement: Compile and analyze test results to recommend and implement improvements in formulation development, from lab to production. Adjust batches and validate specifications as necessary. •Data Analysis & Reporting: Accurately collect, process, and interpret data, drawing scientifically sound conclusions. Prepare comprehensive reports and submissions based on weekly schedules to convey findings to both technical and non-technical stakeholders. •Product Stability & Troubleshooting: Ensure product stability throughout the development process, troubleshoot issues as they arise, and oversee the formulation's transition from lab scale to production, including supervising pilot and initial production batches. •Documentation & Compliance: Maintain accurate real-time entries in lab notebooks, issue ingredient listings and product specifications, and create/update SOPs as they relate to Research and Development. Adhere strictly to GMP and SOP standards, ensuring high quality, compliance, and safety. •Innovation & Technology Utilization: Integrate existing and new analytical technologies into development programs to foster innovation within the analytical chemistry community. •Training & Mentoring: Assist in training and mentoring junior chemists to promote professional growth and advancement within the team. •Cross-Functional Collaboration: Work closely with sales, marketing, regulatory, operations, and manufacturing teams to understand business objectives and provide technical support throughout the product lifecycle, including pre- and post-market phases. •Instrumentation & Housekeeping: Perform general troubleshooting and maintenance of lab equipment, calibrate R&D lab equipment as needed, and maintain a clean and organized lab environment. •Industry Awareness & Professional Development: Stay informed of consumer trends, advancements in analytical chemistry, and participate in cosmetic seminars and meetings to enhance product development efforts. •Flexibility & Additional Duties: Be flexible and willing to perform additional duties as needed, such as filling lab batches into components, preparing evaluation sheets and labels, assisting in company audits, and other tasks as instructed by R&D Management. •Regulatory Communication: Effectively communicate project statuses through technical reports, presentations, and regulatory submissions.

我們正在尋找一位專業且富有熱忱的科學家，負責抗體藥物的臨床前開發，並參與專利撰寫、學術發表及國內外研討會報告。理想的候選人需具備良好的抗體藥物開發與分析能力，能夠整理研發結果，並與跨部門團隊合作推動抗體藥物從研究階段向臨床開發邁進。 如果您對抗體藥物的創新開發充滿熱情，並希望參與推動突破性的生物製藥研究，歡迎加入我們的團隊！ 主要工作內容： ‧領導並分析抗體藥物的臨床前開發策略，推動專案進展。 ‧整理與解析研發數據，為藥物開發提供決策依據。 ‧撰寫專利申請，保護技術創新。 ‧發表研究成果，撰寫學術論文，並於國內外研討會進行報告。 ‧與跨部門團隊合作，確保專案從早期研究順利推進至臨床階段。

【工作內容】 ・QSD文件管理與申請 ・医療機器許可登録/変更/展延申請 ・產品法規審核 ・成分配方之進口法規審核 ・產品中標依照商品標示法相關審核 ・化粧品成分登録作業/產品PIF文件管理 【必須條件】 ・英文／初級商用程度 (TOEIC 700分以上、讀寫為主) ・3年以上具醫療器材查驗登記相關經驗 【歓迎條件】 ・具藥廠或、或化學相關產業經驗佳 ・熟悉醫療器材品質標準ISO13485佳 ・具化妝品安全資料簽署人員SA證照加分

1. 藥品研發專案執行。 2. 藥品劑型設計研發。 3. 藥品製程研發及優化。 4. 原物料及藥品分析樣品配製。 5. 執行產品試製生產。 6. 研發資料撰寫及整理。 7.法規規格確認。 這個職位在醫藥行業中扮演著至關重要的角色， 將有機會參與到各種藥品研發項目， 目前本公司主要項目為： ※細胞培養及藥效試驗平台操作、外泌體純化製程開發。 若您對醫藥研發充滿熱情， 並擁有相關的專業經驗和技能， 歡迎加入我們團隊！

工作內容： 1.協助進行生物樣本的前處理，以供後續分析實驗使用。 2.執行檢體的文書處理以及檢體資訊的登錄與管理。 3.執行實驗室行政業務和文件管理，支援分析試驗並協助儀器設備的基本維護。 4.維護實驗室的日常運作，包含環境清潔與設備管理，並執行主管交辦之其他事項。