發酵技術員
- 高雄市路竹區
- 經歷不拘
- 高中
1、原物料包裝拆除與投料;發酵槽及乾燥設備操作。 2、填寫生產批次表單紀錄。 3、作業過程簡易故障排除。 4、作業環境清潔維護。 5、其它主管交辦事項。 6、依產線需求,需配合平日、假日加班。
1、原物料包裝拆除與投料;發酵槽及乾燥設備操作。 2、填寫生產批次表單紀錄。 3、作業過程簡易故障排除。 4、作業環境清潔維護。 5、其它主管交辦事項。 6、依產線需求,需配合平日、假日加班。
1、依照SOP 生產流程和排程來順利完生產作業。 2、操作混製設備/顆粒設備,維持設備及環境整潔。 3、執行主管交辦事務。 4、依交貨需求,需配合平日、假日加班或輪中班(輪班津貼另計)。
【About the role】 Acepodia is seeking an experienced and engaging a quality person to strengthen our Quality & Compliance function. The successful candidate will provide hands-on support for Policies, Standards, and Global Procedures (major markets, such as US and EU), and documentation for local licensure and/or permits. The position will ensure that a quality assurance (QA) system is in place and maintained and in compliance with Acepodia quality standards and with US GMP /PICS GMP/GTP and the local regulatory requirements; participate in managing eQMS system and its implementation; and facilitate continuous improvement in support of GMP manufacturing and Technical Operations. The person will support risk-based, phased-appropriate, and timely implementation of actions. This position works closely with Manufacturing, Quality Control, and other GxP supporting functions to ensure compliance. This position will be based in our Taiwan facility.. 【Position Title】 QA Senior Associate, Quality Assurance 【Location】 Taipei, Taiwan. 【Reports to】 Senior Director of Quality Assurance (QA) 【Job Type】 Full-time 【Education /Background】 • Bachelor’s degree or above in Sciences, Pharmacy, Engineering, or related field. • A minimum of 5 years of relevant experience in a regulated environment with 3 years focused on product quality preferred. A manufacturing experience in a GxP environment (biotechnology, pharmaceutical, and/or cell therapy field) will be plus. • Knowledge of biotech operations, bulk and finished product manufacturing via aseptic processing is required; cell therapeutic product experience is a plus • Fluent verbal and written communication in both English and Mandarin 【Responsibilities include, but are not limited to】 • Provide quality assistance to the quality assurance (QA) system in compliance with Acepodia quality standards and with US GMP /PICS GMP/GTP and the local regulatory requirements; • Manage Quality Management System related SOPs through eQMS system , and be responsible for their implementation • Training program on quality systems and based on GMP requirement (training program, training record). • Handling deviations (including receiving, recording, investigating and closing out) to ensure timely resolution of the issues. • Assuring quality changes are documented according to a formal Change Control process and that the appropriate actions are taken before implementing the changes. • Assuring corrective and preventive actions (CAPA) are timely defined, documented, tracked and closed in order to improve continuously the quality of the quality processes. • Assuring critical vendors are qualified (maintaining a vendor list, assuring vendor are regularly monitored / followed up). • Provide support and monitor quality issues resolution within the organization and with the external suppliers. • Handling the quality document management including issue the controlled documents and archiving and maintenance. • Develop GMP and QA knowledge and implementation to its highest standard, which is essential for the company to maintain its strong quality. • Provide a oversight for the qualification of facilities, equipment, and systems • Provide a oversight on validation deliverables, i.e. protocols, reports, specifications, system risk assessments, etc.
【About the role】 You will join Preclinical team and facilitate process development of new antibody-drug conjugates (ADC) for cancer and other indications. Projects span both the internal pipeline as well as pharma- and biotech partnered programs, allowing for external interaction. You will be responsible for development of assays to characterize potential targeting moiety for a variety of customized drug conjugates. You will generate corresponding antibody-drug conjugate leads, perform bioanalytical analyses on the resulting leads, and facilitate evaluation of the clinical applicability of candidates. You will be expected to be a good team player, work with enthusiasm to execute assignments properly in the team and cross functional teams. You will accurately report your work and contribute to internal project meetings. 【Position Title】 (Sr.) Research Scientist 【Location】 Taipei, Taiwan. 【Reports to】 Principal Scientist 【Job Type】 Full-time 【Education /Background】 • PhD or MSc (with 5+ years working experiences) in chemistry, pharmacology, toxicology or related fields • Research experiences in a laboratory setting with ADC process development and characterization along with experiences in cell culture skills (primary T cell culture is a plus) and pharmacokinetics/pharmacodynamics/toxicology studies. The experiences in ADC process development and characterization include identifying qualified binder of ADC, familiarity with strategies of conjugation of binder with linker-payload, purification of the ADC product, and developing formulation of ADC. 【Responsibilities include but are not limited to】 • Conduct process development of ADC pipelines and optimization of ADC manufacturing condition. ✔ Develop scale-up process of corresponding ADC pipelines ✔ Characterize the specification of corresponding ADC pipelines ✔ Generate SOP of each scale-up process for corresponding ADC pipelines • Support ADC assay development for characterization and PK/PD/tox studies and studies required for IP portfolio, including: ✔ Generation of required materials for subsequent ADC development ✔ Characterization of ADC product via various functional tests (i.e. RP-HPLC, SEC-HPLC, SEC-HPLC, LC-MS, FACS, ELISA, IF, reporter assays and IHC) ✔ Pharmacodynamics, pharmacokinetics, and toxicology analyses (i.e. in vitro cytotoxicity assay, in vivo potency study, and rodent and no-human primate toxicology studies) • Ensure on-time delivery of qualified products and reports. 【Position Requirements & Relevant Skills & Experience】 • PhD or MSc degree in chemistry/pharmacology/toxicology. Industry experience in process development and/or manufacturing od ADC products is required. • Experience in managing CMO or CDMO of ADC manufacturing is a plus. • Experiences in Good Manufacturing Practice of ADC manufacturing is a plus. • Experience in functional analysis of biologics is required. • Demonstrated analytical thoughts and understanding of optimal experimental design. • Perform experimental procedures, following the company's SOPs • Good communication and interpersonal skills • Familiar with patent application is a plus • Have proficiency in English is a plus.
1. 潔淨室環境監控採樣與檢測 2. 微生物樣品檢驗 3. 微生物實驗室設備定期保養及校正 4. 微生物實驗室環境之維護 5. 微生物菌株與培養基使用管理 6. 參與調查微生物分析相關偏差及不合規事件 7. 熟悉P2實驗室相關作業及SOP維護及更新 8. QC微生物實驗室相關作業經驗2年以上 9. 主管交辦事項
我們是全新科技咖啡品牌nxcoffee,我們團隊非常年輕,也希望能培養志同道合的夥伴一起加入! 【工作內容】 吧檯相關事務: 1.咖啡沖煮(義式/手沖) 2.製作鬆餅、熱壓吐司、主餐系列之餐點、輕食、飲品 3.吧檯整潔 4.點餐、收銀 5.其餘主管交辦事項 【上班時間】 中班:11:00-18:00 中班:14:00-22:00 晚班:16:00-23:00 備註1. : 歡迎無經驗、肯學習、有服務熱忱、客人至上的心! 備註2.:國定假日、年節期間須配合各門市營運需求進行排班。
1.制定集團HR策略 2.負責組職發展規劃,執行人力盤點及招募作業 3.監督集團各BUHR選、用、育、留、考核等功能執行進度及考核成果 4.制定及監督集團人才發展計劃 5.制定及修訂HR規章制度 6.維護及推動績效管理制度 7.研擬制定集團薪酬制度 8.維護良好員工關係
我們是全新科技咖啡品牌nxcoffee,我們團隊非常年輕,也希望能培養志同道合的夥伴一起加入我們團隊成為儲備主管,未來依照營運規模輪調其他單位/店面,“培養重點”如下: 1.熟悉店務及SOP:學習每日例行店務及熟悉飲品、餐點、開班、收班等等的SOP 2.教育訓練:熟悉店務及SOP後需有能力對新進夥伴進行教育訓練 3.智能熱浮風烘豆設備 : 熟練操作設備、熱浮風烘豆原理介紹、設備介紹、連鎖加盟方案介紹、清潔維護、維修通報 4.世界精品咖啡 : 世界精品咖啡介紹(生豆、熟豆、飲品、風味) 5.貨品管理 : 進貨、存貨庫存整理盤點 6.品質管理 : 依照公司規定店面SOP,執行餐點製作與咖啡飲品調製的品管,執行咖啡豆風味品管。 7.顧客關係 : 商品介紹與銷售、引導協助顧客點餐、收銀結帳、讓顧客達到愉快的消費,提高品牌滿意度 8.維護店內的環境清潔,設備維護與管理 9.行銷活動推廣,店周邊精耕,品牌行銷,創造好口碑 10.需配合門市輪早晚班及假日班,需配合營運部輪調 備註1. : 歡迎無經驗、肯學習、願挑戰高薪、期許自己成為領導者,培訓期間不需負擔管理責任 備註2.:國定假日、年節期間須配合各門市營運需求進行彈性排班。
1.辦公室內勤,協助行政事務 2.了解金融業及半導體產業尤佳 3.客戶端及產業端 聯繫窗口 4.曉通Excel/Words/PPT等文書處理 尤佳 5. 主管交辦事項
1、協助場地及課程預約 2、接待客人並介紹館內設施與環境 3、協助極限運動推廣、提倡運動正確觀念 4、維護館內整潔 5、企劃館內各項活動 6、對極限運動有熱情
1. Manage contract manufacturing organization related activities, project management, daily communication and meeting with vendors, PR/PO/Contract activities, equipment maintenance, material purchasing, and provide product information and communication between OBI and foreign & domestic CMO. 2. Assist with vendor selection perform vendor search, due diligence, facility inspection, and vendor evaluation. 3. Supply management closely with other teams to ensure the production supply suffices for development study and clinical trial requirements and is delivered promptly. 4. Manage technical transfer to contract manufacturing organizations assist R&D in transferring technical information to the CMO. 5. Budget control, including payment and invoice management, ensure the payment on time, and clarify the issue of finance. To be familiar with the ERP system. 6. Troubleshooting the issues in manufacturing activities, actively reflecting on the issue to the supervisor, and solving them promptly. 7. To complete the assignment by the supervisor.
1. 規劃與執行集團訓練發展活動(IDP個人發展計畫) 2. 執行年度晉升作業 3. 年度教育訓練需求分析、規劃、執行與成效評估 4. 優化人資制度與作業流程 5. 協助推動公司政策與制度之執行 6. 彙整人資管理報表、集團KPI每月進度追蹤 7. 管理集團E-Learning系統 8. 其他主管交辦事項
【工作內容】 • 根據 GMP/GTP規範,進行潔淨區清潔及消毒 (需著無塵服) 2. 潔淨區廢棄物處理 3. 無塵衣整理、清點以及送洗 4. 無塵衣及耗材補充 5. 廠房其他區域清潔維護 6. 其他主管交辦事項 【其他條件】 • 夠獨立工作和團隊合作 • 能專注於細節和準確性
1. Participate and contribute to the implementation of strategies and timelines to ensure a successful clinical or commercial product launch, including oversight of CMOs, manufacturing strategy, priority, and forecasting activities that impact overall drug requirements. 2. Roll out serialization for commercial manufacturing to meet requirements and product traceability. Interface with SC, CMC, AD, RD, Quality Assurance, Procurement, PMO teams, etc. to ensure timely implementation of the requirements. 3. Overview of the manufacturing activities and well-planned for all products. Manage the technical transfer to CMOs, manufacturing drugs for the demand of clinical and commercialization. 4. Having excellent troubleshooting on any issues for completion/accuracy of the product timeline. CMO management globally including common and emergency productions of DSI/DS/DP for target timeline. 5. Interact with cross-functional departments to provide the required information or move forward with the projects. 6. Project management including normal and emergency production of DSI/DS/DP. Manage the equipment maintenance and purchasing the necessary materials. 7. Budget management including payment and invoice management of all CMOs. 8. To complete the assignment by supervisor.
1.負責營業樓面之營運管理及廠商活動聯繫 2.負責商品促銷活動規劃及執行 3.負責營業樓面各項人、事、物執行管理 4.檢討各項商品銷售分析 5.市場調查與招商
1. 應收帳款及信用額度管理 2. 總帳、成本會計及管理分析報表 2. 主管機關規定之公告申報作業 3. 公司或部門指派任務 ※將依據應徵者的學、經歷核定職稱及薪資
【About the role】 We have an exciting opportunity for motivated individuals to join our CMC team working to develop cell therapies against cancer. The successful candidate will be expected to be a good team player, work with enthusiasm to execute assignments properly. 【Position Title】 (Sr.) Research Associate (CMC) 【Location】 Taipei, Taiwan 【Reports to】 Principal Scientist 【Job Type】 Full-time 【Responsibilities】 • Support IND enabling related study. • Optimize immune cell culture process. • Develop new projects generally on a yearly basis. • Manufacture cell therapy products in a GTP lab as a core team member. • Conduct QC tests to secure safety, stability, and efficacy for our valuable products. • Establish and maintain the documentation system. 【Qualification】 • Passionate about research, self-motivated, values teamwork, willing to join the international cell therapy drug development field. • Good communication and interpersonal skills. • Familiarity with flow cytometry-based experiments is a must. • Familiarity with tumor-killing assay experiments is a plus. • Familiarity with GTP Lab practice is a plus. 【Academic and/ or working experience】 • MSc (or above) in life science or related fields (pharmacology, immunology, chemistry, and biochemistry). • 2+ years of working experience with cell culture as the primary duty.
1. 一般事務性行政工作 2. 郵件、文件、貨運的收發 3. 協助整貨.理貨.發貨 4. 進貨清點並建檔 5. 維護辦公室環境與設備之整潔 6. 主管交辦的工作事項
【About the role】 We have an exciting opportunity for motivated individuals to join our clinical operations team working to bring cell therapies to the clinical stage. The successful candidate will be expected to be a good team player, work with enthusiasm to execute assignments properly. 【Position Title】 Senior Clinical Trial Manager/ Clinical Assistant Program Manager (title may be adjusted based on experience) 【Location】 Taipei, Taiwan 【Reports to】 Senior Clinical Operations Director 【Job Type】 Full-time 【Education /Background】 • Bachelor’s degree or above in healthcare and life science related field • 5+ years of Clinical Research experience that includes a minimum 3 years relevant experience as a Senior CRA or Principal CRA (in a Lead CRA role), or at least 1 years as a Project Manager, CRA Manager, Clinical Trial Manager or equivalent job role. • 2+ years of experience working at clinical sites in Taiwan or with clinical sites via trial management or monitoring role, or a combination of bothOncology experience, with cell therapy experience strongly desired. • Robust understanding of ICH/GCP and regulatory requirements • Specific Project Management training, or Clinical Research training and/or certification is a plus 【Responsibilities include, but are not limited to】 • Clinical trial planning and management in all aspects: study document development/review (study-specific plans, manual, and guidelines, etc.,), clinical trial operation, study budget planning, and study metrics. • Ensures clinical trials are conducted in compliance with the study protocol, health authority regulations, and ICH/GCP guidelines: planning quality assurance initiatives for the clinical trials, participating the audit activities and coordinates resolution of audit findings of vendors and CROs (including CAPA documentation and resolution); ensures audit-ready condition of clinical trial documentation with vendors and CROs. • Manages the study submission to health authority and IRB/ECs in coordination with project team, vendors and CROs. • Provides study-specific training and leadership to clinical research staff, including vendors, CROs, sites and/or other contract personnel if required. • Take the lead with study team to select external vendors and is responsible for the management/oversight of external vendors including: the development of vendor specifications; review vendor reports, budgets, and metrics. • Take the lead with study team to manage the study budget: Ensures the study budget execution aligns with study plan; reviews and approves study invoices against approved budget. Coordinates review of revisions and/or change orders with vendors, if necessary • Prepares and presents project debriefings to Head of Clinical Operations/CMO • Uses operational expertise to optimize study operation design and works with the study team to strategize on clinical trial conduction. • Works with the CRO to select and approve sites and manages start-up processes toward activating sites; develops relationships with investigators and site staff. • Works cross-functionally with Clinical Development, Data Management, CRO, vendors, and clinical investigators/site staff to proactively manage the conduction of the clinical trials. • May require occasional domestic and/ or international business travel. • May require occasional evening working hours for attending international teleconferences • Other duties and assignments as required by the project. (May be assigned to the project team in the joint project with other departments (e.g. quality assurance, business development, operations)
• Represent clinical pharmacology for the assigned study team to support clinical study conduct from clinical pharmacology perspectives. • Translate nonclinical data to human efficacious dose projection. • Design experimental PK or PKPD studies in animal or human to better understand the clinical pharmacology of compound in development. • Conduct Non-Compartmental Analysis (NCA) for nonclinical and clinical PK studies and writing the PK reports. • Work with vendor or perform in-house population PK and PKPD analyses. • Responsible for preparation of regulatory submissions such as IND submission, and response to health authority’s questions with respect to clinical pharmacology.
1. Assess risk in internal controls. 2. formulate the annual audit plan according to the risk assessment results and the mandatory requirements of laws and regulations. 3. Review self-inspection reports prepared by all departments and subsidiaries and submit self-assessment reports along with reports on the correction of defects and irregularities in internal control systems discovered by the internal audit departments. 4. Review audit reports submitted by each subsidiary and follow up on the correction of any defects and irregularities in internal control systems. 5. Execute the approved annual audit plan, including specific tasks or plans required by the management, the board of directors and the audit committee. 6. Follow-up audit findings and corrective actions. 7. Prepare the data and ask for Finance Department’s help to report on Market Observation Post System(公開資訊觀測站) according to mandatory requirements of laws and regulations on Jan., Feb., Mar., May, Dec. 8. Provide advice on improving operational process efficiency and consulting services on the design of internal control systems. 9. Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications and content, and participating in professional societies. 10. Report audit findings to the Chairman and the Board, providing insights on area of strength and improvement. -The job title and salary will be adjusted based on experience. 1. 評估內部控制風險。 2.根據風險評估結果和法令要求,制定年度稽核計畫。 3.審查各部門和子公司編制的內控自評報告,提交內控自評覆核報告。 4.覆核各子公司提交的稽核報告,追蹤內部控制制度缺陷及違規行為的糾正情況。 5.執行核准的年度稽核計劃,包括管理階層、董事會和審計委員會要求的具體任務或計劃。 6. 追蹤稽核結果和糾正措施。 7、依法令要求向公開資訊觀測站申報。 8、提供內部控制制度設計的諮詢。 9. 透過參加教育研討會、查閱專業出版物和內容以及參加專業協會來保持專業和技術知識。 10. 向董事長、審計委員會及董事會報告稽核結果。 工作職稱和薪資將根據經驗進行調整。
1.餐廳外場服務,安排客人入座 2.開餐前的前置作業,協助餐廳補菜 3.收拾、清潔餐盤,支援內場洗碗 4.公共區域的清潔整理 ⭕️上班時段06:00~11:00