1. 採購相關作業協助(設備、工程及維護保養之採購詢、比、議價) 2. 請款相關作業(收貨單、發票核對與收貨時程跟催) 3. 協助處理採購事務(供應商建檔、交期跟催) 4. 採購單及合約掃描、歸檔 5.ERP系統使用
1. 人才培育發展專案推動 2. 年度訓練預算編列及部門培訓計畫 3. 內/外部教育訓練規劃與執行 4. 政府補助案申請、執行及核銷作業(大人提補助計畫或其他) 5. TTQS申請評核作業 6. 公司內部⼈⼒資源文件紀錄、維護與管理 7. ⼈才招募、甄選、任⽤、報到、離退作業 8. 員工相關面談(招募、離職、績效..等) 9. 不定期協助招募及員工活絡化活動協辦 10. 各項人資專案執行 11. 其他主管交辦事宜
1. 洗瓶, 組裝與滅菌 2. 實驗耗材準備 3. 物品歸位 4. 實驗室與辦公室清掃 5. 其他主管交辦事宜
1. 內部稽活動安排、稽核議程相關資料準備、及稽核報告與缺失回覆進度追蹤。 2. GMP 年度教育訓練安排，包含事前與外部單位聯繁，訓練資料準備及場地安排。 3. 彙整品質保證合約的審閱者意見，跟催審閱進度，以及品質保證合約登錄與歸檔。 4. 發送品質會議通知、議題收集與會議紀錄。 5. 追蹤供應商稽核報告與缺失回覆進度。
1. 管理協調CDMO專案，確保從規劃到報告之任務交付。 2. 與專案團隊成員(包含但不限於委外包商)合作已達成專案目標。 3. 追蹤專案進度與任務狀態。 4. 管控專案資源、預算、時程、範圍及品質。 5. 進行風險管理以降低專案風險。
1.微生物上游及動物細胞上游生產製程參數技轉（Technology transfer）、製程放大及原物料用量規劃、協作建立 GMP 生產物料表（BOM）及製程中管制（IPC）設計 2.原物料規格書及供應商評核建立 3.GMP 生產相關支援，如審閱生產批次紀錄母檔、異常調查、變更管制、矯正及預防（CAPA），以及技轉計畫、取樣計畫及試驗計畫/報告等文件撰寫與執行 4.分析並統整跨專案之製程效能和產品品質數據 5.協作新產品導入風險評估（NPI） 6.協作執行製程特性確認前製程參數風險評估（pre-PC PPRA）
1. Analytical method development for cell assay (e.g., Anti-proliferation, ADCC,ADCP CDC, Apoptosis, etc.) 2. RD sample analysis and report. 3. Coordinate CDMO or internal projects. 4. Compile related protocols and reports.
1. 執行建廠環安衛例行性工作，如自動檢查表查核、作業環境監測事項等。 2. 現場及建廠環境安全衛生稽核、管理及協助。 3. 執行維護職業安全衛生系統(ISO 45001)、環境管理系統(ISO 14001)及能源管理系統(ISO50001)。 4. 執行安全衛生教育訓練與宣導。 5. 執行職安相關業務及其他主管交辦事項。
1.Execute the tasks including documentation for eQMS system build, validation and deployment. 2.Coordinate the eQMS implementation activities within Xizhi and Zhubei sites of EirGenix. 3.Be an internal trainer who delivers periodic training courses regarding the use of eQMS to new users after system deployment. 4.Maintain eQMS in the validated state during its lifecycle. 5.Overseeing the qualification of computerized systems to ensure it meets regulatory requirements and is suitable for its intended use. This involves coordinating activities such as Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). 6.Participating in change control processes to assess the impact of proposed changes to computerized systems, ensuring that changes are properly evaluated, documented, and implemented in compliance with regulatory requirements.
1. 執行內外部專案的技術轉移（Technology transfer），製程放大設計和規劃 2. 新產品導入風險評估 3. GMP 生產相關支援，如異常調查、變更管制、矯正及預防（CAPA）、試驗計畫/報告等文件撰寫與執行 4. 協作執行製程確效（PPQ）和持績製程確認（CPV） 5. 分析並統整跨專案之製程效能和產品品質數據 6. 製造廠之製造技術開發專案的主導與執行
1.動物細胞培養製程開發、製程放大及技術轉移(technology transfer) 2.撰寫研究計畫、製程開發報告及技轉相關資料。 3.參與專案相關會議。 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. Physicochemisty related analyses,including mthod development and routine GMP sample analyses(e.g.,HPLC/UPLC, CE, PAGE, analyses for Raw Materials). 2. Analytical method validation. 3. GMP documents preparation (e.g., SOP, equipment qualifications, AMV protocol /report, deviation,OOS/OOE). 4. Equipment maintenance and related document preparation. 5. Support international audit/inspection. 6. Support project coordination as a project coordinator.
1.動物細胞培養上游製程開發 2.產品回收製程開發 3.上游製程技術放大及轉移 4.撰寫研究計畫及製程開發報告 5.實驗數據統計分析及實驗室環境、設備及耗材管理維護 6.其他主管交辦事項
1. Perform microbial-related analysis, including method development, in-procss, drug substance, study plan samples. (e.g. Microbial enumeration test, Sterility, Bioburden, Growth promotion test, Microbial characterization). 2. Prepare GMP documents (e.g. SOP, qualification report, AMV protocol /report) and able to participate in quality incident investigation (e.g. deviation, OOS/OOE, CAPA). 3. Purchase and maintenance of equipment, reagent and consumable. 4. Support internal and external audits and improve responses to non-compliant. 5. Support project coordination as a project coordinator.
1.負責生產設備的日常維護和定期驗證 2.cGMP廠區例行性維護，確保製造過程符合GMP等相關法規和行業標準 3.生產流程障礙排除 4.cGMP生產製造相關文件撰寫與審閱(如偏差調查報告、CAPA 、change control、risk 5.assessment、PBR、SOP、IOQ & Study report)。 6.生產製程設備操作(蛋白質純化/分析、過濾、層析系統、病毒清除) 7.跨部門協作製程技轉
Mammalian cell line engineering group is seeking for a highly motivated, independent and enthusiastic scientist/research associate. The ideal candidate shall possess good communication skills, be actively involved in the group activities, and willing to engage in disciplinary and interdisciplinary collaboration across departments. The candidate should be passionate and highly skillful about mammalian cell metabolic engineering and genomic editing. Responsibilities for this job are: 1. Responsible for cell line engineering. 2. Aid in tech transfer of CDMO projects and bioprocesses to internal departments. 3. Data analysis and report writing.
1. Perform physicochemisty-related analysis, including method development, in-procss, drug substance, study plan samples. (e.g. HPLC, PAGE, A280, BCA, Bradford assay). 2. Prepare GMP documents (e.g. SOP, qualification report, AMV protocol /report) and able to participate in quality incident investigation (e.g. deviation, OOS/OOE, CAPA). 3. Purchase and maintenance of equipment, reagent and consumable. 4. Support internal and external audits and improve responses to non-compliant. 5. Support project coordination as a project coordinator.
An enthusiastic and self-motivated senior technical manager is sought after by our mammalian cell engineering group. The ideal candidate will demonstrate excellent communication skills, actively engage in group activities, and embrace collaborative opportunities across disciplines. We are looking for someone passionate and proficient in mammalian cell metabolic engineering and genomic editing. Responsibilities for this role include: 1.Conducting cell line engineering and platform optimization. 2.Overseeing cell culture medium development.
1. 下游製程操作 2. 下游製程設備維護與校驗 3. 協助資料彙整 4. 其他交辦之廠務工作
1. CDMO Client Development and Management ◼ Engage in direct and indirect (phone/web/email) overseas client sales and business development 2. CDMO Marketing, Advertising, and Branding ◼ Develop and initiate digital promotions/advertising/outreach ◼ Coordinate domestic and international exhibitions and conferences (live and online) Develop and manage company’s online/social media presence 3. CDMO Business Development 4. Market research and analysis / Proposal preparation / COG analysis 5. Manage the BD team and response for revenue & profit. 6. Coaching and training