育世博生物科技股份有限公司

【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 【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.

【About the role】 Acepodia seeks a highly motivated and experienced GMP Facility Engineering Manager to join our team. The GMP Facility Engineering Manager plays a crucial role in overseeing the design, maintenance, and operation of our facility and its associated equipment and systems, ensuring compliance with all Good Manufacturing Practices (GMP) regulations. This position demands a strong understanding of engineering principles, GMP guidelines, and project management methodologies, along with excellent leadership and communication skills. 【Position Title】 (Sr.) Manager of GMP Facility Engineering 【Location】 Taipei, Taiwan. 【Reports to】 CTO 【Job Type】 Full-time 【Responsibilities include, but are not limited to】 Project Management & Compliance: • Develop and implement comprehensive project plans for facility modifications, equipment upgrades, and new installations, including scope, timelines, resources, and budgets. • Manage the design, planning, construction, and maintenance of buildings, equipment, and other facilities to ensure compliance with GMP regulations. • Ensure that all engineering projects, initiatives, and processes conform to the organization's established policies and objectives. • Oversee the equipment, facilities, and utilities validation program, ensuring that all systems meet regulatory requirements and company standards. • Manage the department's operating budget and contribute to the development of the facility's annual and long-term strategic capital investment plan. Leadership & Collaboration: • Lead and actively participate in client interactions regarding equipment, facility, and utility lifecycle management. • Provide technical expertise and guidance to cross-functional teams, including manufacturing, quality assurance, and validation. • Manage and supervise third-party contractors and other internal service providers, ensuring that all work is completed according to procedures and health and safety standards. Maintenance & Continuous Improvement: • Identify and implement continuous improvement initiatives to optimize the performance and reliability of process equipment, utilities, and facilities. • Maintain and coordinate engineering maintenance support on off hours, as necessary. • Manage the calibration program and the Planned Preventative Maintenance program. Training & Safety: • Ensure that GMP is adhered to in all areas of work and that all employees understand and follow department objectives, company policies, and procedures. • Maintain a safe working environment and ensure compliance with all relevant safety regulations. • Oversee and ensure that all employees undergo GMP training to fully understand their roles and responsibilities in maintaining compliance. • Documentation & Reporting: • Contribute to the development and continuous improvement of Standard Operating Procedures (SOPs) and Standard Work Instructions. • Manage the process for creating SOPs and other documentation for facility equipment maintenance plans, manufacturing equipment maintenance plans, calibration SOPs, and the reliability engineering program. • Support Commissioning and Validation activities as needed. • Support Development Engineers and Equipment Vendors in delivering Equipment Turn Over Packages (ETOPs). • Work closely with all functional departments to ensure the continued maintenance of a validated environment according to cGMP and other regulatory requirements. • Deliver high-level reporting to directors and other leadership. • Operational Support: • Provide a daily presence in manufacturing and facility areas to support operations by troubleshooting and resolving complex technical issues.

【About the role】 The Manager/Associate Manager of PM and Corporate development will assist in identifying and assessing potential market opportunities for existing products, new products, and new development directions. They will also conduct competitive analysis, including monitoring competitors. Additionally, this role involves cross-functional and collaborative work within Acepodia to oversee projects that aid product development and coordination between Acepodia and partners to support industry-academia collaboration projects/alliance management. This position also needs to assist the CEO office in optimizing the management and coordination function. 【Position Title】 PM and Corporate Development manager/Associate manager 【Location】 Taipei, Taiwan. 【Reports to】 EA, Director of Business Development and Intelligence 【Job Type】 Full-time 【Education /Background】 • Bachelor degree or above in biotech/life science, pharmacy/pharmacology or related field; MBA degree or PhD degree is a plus. • More than 3~5 years of work experience in the biotech/pharma industry. • Experience in project, product or program management related activities, additional experience in industry/market intelligence or business consulting is a plus. • Familiarity with new drug development regulatory pathways, and knowledge of or experience in the drug manufacturing and formulation process, is a plus. • Fluency in Mandarin Chinese and English. • Ability to travel as needed. 【Responsibilities include, but are not limited to】 • Establish, maintain and monitor program/project timelines and keep consistency within the detailed program/project timelines to ensure cross-functional alignment to execute program/project goals and deliverables. • Collaborate and coordinate with cross-functional team members to identify and resolve bottlenecks and critical issues to keep the project on track. • Manage project documentation, including requirement documents, meeting minutes, and other relevant materials, ensuring information is complete and accurate. • Organize and conduct project meetings, fostering efficient collaboration with team members through excellent communication skills. • Support product development through coordination and management of external partners or vendors. • Set up and maintain project management tools to enhance project management efficiency and effectiveness. • Perform market/industry analysis including collecting/organizing market/industry information, analyzing data, conducting competitive analysis, and making forecast/financial model. • Track and note competitor activities including companies and products. • Collaborate and coordinate with cross-functional team members and leaderships to achieve business goals. • Support CEO office to monitor, follow up and coordinate high-level or essential action items cross departments and ensure CEO office operation efficiently. • Other tasks assigned by supervisor. 【Relevant Skills & Experience】 • Ability to read, analyze, and interpret general business periodicals, professional journals, and technical procedures. • Ability to quickly assess situations and opportunities, anticipate potential issues and suggest creative alternatives to overcome barriers. • Ability to work/communicate within a multi-functional, global team structure and to motivate team members with strong interpersonal skills. • Demonstrated the potential to build rapport with therapeutic and functional area leaders. • Strong analytical skills required for market/industry and competitive analysis. • Ability to perform data analysis through appropriate software including spreadsheet (e.g. Excel), and present it in good graphs and tables. • Strong presentation skills. • Comfortable in a results-driven, highly accountable environment where you can make a clear impact.

【About the role】 As a Regulatory Affairs Manager / Associate Manager, you will play a critical role in shaping and executing our regulatory strategy. You will be responsible for ensuring our investigational products comply with all relevant regulatory requirements. This position offers a unique opportunity to work at the forefront of drug development, interacting with health authorities and internal teams to guide products through key development milestones. Your expertise will directly influence the success of our pipeline and the speed at which life-changing therapies reach patients. 【Position Title】Regulatory Affairs Manager / Associate Manager 【Location】 Taipei, Taiwan 【Reports to】 Director of Regulatory Affairs 【Job Type】 Full-time 【Responsibilities include but are not limited to】 • Develop and execute regulatory strategies to support the development and approval of investigational products. • Support global regulatory submissions and filings. Prepare, compile, and submit regulatory documents to the regulatory agencies, ensuring compliance with applicable regulations and guidelines. • Oversee regulatory submissions including pre-IND, IND, NDA, and amendments. • Collaborate with cross-functional teams including R&D, clinical, quality, and manufacturing to ensure regulatory requirements are met throughout the product lifecycle. • Track regulatory timelines and ensure timely submissions. • Maintain up-to-date knowledge of relevant regulations, guidelines, and industry best practices in Taiwan, the US (FDA), and other key markets. • Liaise with regulatory authorities and act as the primary point of contact during inspections, audits, and other interactions. • Support the assigned Regulatory Affair activities/tasks. 【Position Requirements & Experience】 • Bachelor’s degree or above in Pharmacy, Life Sciences, Biotechnology, or a related field. • Minimum of 3 years of experience in regulatory affairs within the pharmaceutical or biotech industry. • Experience with US FDA submissions (e.g., pre-IND, IND) is highly preferred. • Familiarity with regulations related to cell therapy is a strong plus. • Familiarity with electronic Common Technical Document (eCTD) submission format is an advantage. • Experience or understanding of CMC-related regulatory requirements or preparation of CMC documentation is a strong plus. • Excellent written and verbal communication skills in both English and Mandarin. • Detail-oriented with strong organizational and project management skills.

【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

【工作內容】 • 根據 GMP 和 GDP 規則接收、儲存和運輸原材料 • 遵守財務要求完成採購流程 • 維護準確的庫存記錄 • 進行週期性盤點和實物盤點 • 依據訂單進行準備及包裝 • 操作倉庫設備，如清潔工具 • 保持倉庫環境的清潔與整潔 • 遵守所有安全程序和法規 【教育&工作經歷】 • 生物相關領域的學士學位或同等學歷 • 1-2 年在倉庫環境中工作的經驗，在製藥行業尤佳 • 對 GMP、GDP 的原則和實踐有深刻理解 • 能夠閱讀並理解安全程序，標準作業程序和法規 • 有能力實施安全要求並具有安全第一的意識 • 優秀的分析和解決問題的能力 • 優秀的溝通和人際交往能力 • 能夠獨立工作和團隊合作 • 瞭解採購流程，包括 PR/PO 和物料接收等流程 【其他條件】 • 夠獨立工作和團隊合作 • 能專注於細節和準確性 • 能夠舉起和搬動重物 • 能夠在快節奏和高要求的環境中工作 • 優秀的溝通和人際交往能力 • 有操作倉庫管理軟體和 Excel 的經驗 • 有參與品質控制作業流程的經驗 • 有遵從GMP、GDP 和法規要求的經驗 • 有參與採購作業的經驗