BeOne Medicines_臺灣百濟神州有限公司

About The Role BeiGene is growing, and we are seeking new team members who are willing to take new challenges and exciting opportunities. The Functional Assessment of Cell Therapy at BeiGene is seeking a highly motivated scientist who believes in the potential of engineered cells to treat cancer and wants to engage with drug development, performing preclinical research and developing novel immune cell therapy. As the Scientist, you will report to the Research Investigator to design and execute proof-of-concept experiments in rodent models and build in vivo functional assessment platforms that can best predict clinical outcomes for various cell-based therapeutic modalities. The Functional Assessment Group at BeiGene spans research from in vitro to in vivo studies and assesses key aspects of drug potency, pharmacology, biomarkers, histology, toxicology and other research that explains how our therapies are safe and effective. What You Will Do • Independently and rapidly establish cutting-edge in vivo functional assessment strategies to achieve project goals and support the preclinical development of cell therapy products against hematological malignancies or solid tumors. • Design and conduct oncology mouse models to evaluate the antitumor activity of novel cell therapy candidates across a range of cell lines and patient-derived xenografts. Establish dose/efficacy relationships. • Design and execute cellular, immunological, and histological experiments based on functional assessment strategies, project timelines, and well-defined goals. • Write and revise standard operating procedures relating to in vivo functional assessment assays. • Analyze data, monitor assay quality, troubleshoot, and present data to project team groups. • Ability to schedule and execute tasks and protocols independently and accurately document all work in a laboratory notebook. What We Are Looking For • Master’s degree with 6+ years of industrial experience • In depth experience in building in vivo PK/PD relationships. • Experience working with rodent models (administration of therapeutics, IV and IP dosing, as well as tissue and blood collection) • Experience working with in vitro cell based assay utilizing multicolor flow cytometry (including Ab titration and compensation), luc assay, incucyte or other analytical techniques to characterize the immune parameters and potency of cell therapy products. • Experience in maintaining primary human immune cells is preferred. • Ability to write detailed in vivo protocols and reports. • Good written and oral communication skills in English • Strong ability to multi-task and work productively in a fast-paced, highly collaborative team environment. What Will Separate You From The Crowd • Detail-oriented, with good multitasking, organizational, prioritization, and time management proficiencies. • Great familiarity with animal study (including handling, necropsy, and IACUC guidelines), flow cytometry, tissue culture and data generation and analysis. • Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures. Must be focused and able to meet tight timetables. What You Should Know • Occasional nights, weekend and holiday work could be required during periods of time to meet deadlines

About The Role BeiGene is growing, and we are seeking new team members who are willing to take new challenges and exciting opportunities. The Functional Assessment of Cell Therapy at BeiGene is seeking a highly motivated scientist who believes in the potential of engineered cells to treat cancer and wants to engage with drug development, performing preclinical research and developing novel immune cell therapy. As the Scientist, you will report to the Research Investigator to design and execute proof-of-concept experiments in rodent models and build in vivo functional assessment platforms that can best predict clinical outcomes for various cell-based therapeutic modalities. The Functional Assessment Group at BeiGene spans research from in vitro to in vivo studies and assesses key aspects of drug potency, pharmacology, biomarkers, histology, toxicology and other research that explains how our therapies are safe and effective. What You Will Do • Independently and rapidly establish cutting-edge in vivo functional assessment strategies to achieve project goals and support the preclinical development of cell therapy products against hematological malignancies or solid tumors. • Design and conduct oncology mouse models to evaluate the antitumor activity of novel cell therapy candidates across a range of cell lines and patient-derived xenografts. Establish dose/efficacy relationships. • Design and execute cellular, immunological, and histological experiments based on functional assessment strategies, project timelines, and well-defined goals. • Write and revise standard operating procedures relating to in vivo functional assessment assays. • Analyze data, monitor assay quality, troubleshoot, and present data to project team groups. • Ability to schedule and execute tasks and protocols independently and accurately document all work in a laboratory notebook. What We Are Looking For • Master's degree with 4+ years related experience in immunology and immuno-oncology. • Experience working with rodent models (administration of therapeutics, IV and IP dosing, as well as tissue and blood collection) and in vitro-based assay (cell culture and multicolor flow cytometry assay, including Ab titration and compensation) is an essential requirement. • Experience in establishing humanized models, autoimmune disease models, and purifying primary PBMC is preferred. • Ability to write detailed in vivo protocols and reports. • Good written and oral communication skills in English • Strong ability to multi-task and work productively in a fast-paced, highly collaborative team environment. What Will Separate You From The Crowd • Detail-oriented, with good multitasking, organizational, prioritization, and time management proficiencies. • Great familiarity with animal study (including handling, necropsy, and IACUC guidelines), flow cytometry, tissue culture and data generation and analysis. • Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures. Must be focused and able to meet tight timetables. What You Should Know • Occasional nights, weekend and holiday work could be required during periods of time to meet deadlines

About The Role BeiGene is growing, and we are seeking new team members who are willing to take new challenges and exciting opportunities. The Functional Assessment of Cell Therapy at BeiGene is seeking a highly motivated Research Investigator who believes in the potential of engineered cells to treat cancer and wants to engage with drug development, performing preclinical research and developing novel immune cell therapy. As the Research Investigator, you will guide the Scientists to design and execute proof-of-concept experiments in rodent models and build in vivo functional assessment platforms that can best predict clinical outcomes for various cell-based therapeutic modalities. The Functional Assessment Group at BeiGene spans research from in vitro to in vivo studies and assesses key aspects of drug potency, pharmacology, biomarkers, histology, toxicology and other research that explains how our therapies are safe and effective. What You Will Do • Develop toxicology strategies and provide expert support to research and development projects in conjunction with program teams. And manage the preparation and presentation of nonclinical safety data for project teams. • Independently and rapidly establish cutting-edge in vivo functional assessment strategies to achieve project goals and support the preclinical development of cell therapy products against hematological malignancies or solid tumors. • Design and conduct oncology mouse models to evaluate the antitumor activity of novel cell therapy candidates across a range of cell lines and patient-derived xenografts. Establish dose/efficacy relationships. • Write and revise standard operating procedures relating to in vivo functional assessment assays. • Analyze data, monitor assay quality, troubleshoot, and present data to project team groups. • Ability to schedule and execute tasks and protocols independently and accurately document all work in a laboratory notebook. What We Are Looking For • A Ph.D., postdoctoral training and at least 4 years industry experience in a field related to in vivo toxicology in a scientific discipline that encompasses the basic biologic sciences, including immune-oncology, stem cell biology, histology, or pathology. • Experience in designing and performing the non-clinical safety studies and in vivo models for monitoring the functionality and safety of cell therapy product candidates. • Solid understanding of cell therapy, immune cell biology, and cellular immunotherapy. • Hand-on experience with in vivo tumor models and proficiency in various techniques, including tumor implantation (PDX, cell lines, etc.) and measurement, administration of therapeutics (IV, SC, IP dosing), blood collection, tissue section, tumor dissection, processing, and preservation. • Experience in conducting ex vivo and in vitro studies, including, but not limited to, animal tissue preparation for histology studies (IHC and ISH), cell-based assays, and flow-cytometry. • Good written and oral communication skills in English • Strong ability to multi-task and work productively in a fast-paced, highly collaborative team environment What Will Separate You From The Crowd • Detail-oriented, with good multitasking, organizational, prioritization, and time management proficiencies. • Great familiarity with animal study (including handling, necropsy, and IACUC guidelines), flow cytometry, immunohistochemistry, tissue culture and data generation and analysis. • Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures. Must be focused and able to meet tight timetables. What You Should Know • Occasional nights, weekend and holiday work could be required during periods of time to meet deadlines

Lab Equipment Maintenance and Calibration Services 1. To update the equipment list for tracking (calibration records, preventive maintenance, warranty expiry) 2. To monitor the utilization of the selected equipment and communicate to the CapEx Review Committee (CARC) 3. To communicate with the area/room manager for collecting requests and feedback 4. To select and train the appropriate vendor for supporting the equipment maintenance 5. To communicate with the suppliers and manage for the lab equipment maintenance and calibration 6. To select and train the appropriate vendor for supporting the equipment maintenance 7. To communicate with the suppliers and manage for the lab equipment maintenance and calibration 8. To keep the equipment calibration and maintenance records according to the status in the equipment checklist Cleanroom Material Management 1. Goods reception and releasing for clean room (SP&O is mainly responsible for the room-temperature materials) 2. Cleanroom material related document processing and archiving External Collaborations 1. Cleanroom warehouse management, including for the external warehouse 2. Cleanroom material inventory tracking and management 3. To communicate and plan for the procedures of material shipment to the external rental manufacturing site 4. To manage and ensure the appropriate material qualification and the import/shipment to the external manufacturing facility Lab Operation Service 1. Consumable ordering and re-supply 2. Gas and liquid nitrogen supply 3. Lab gowning material management Essential Functions of the job 1. Laboratory services of the Cell Therapy site 2. Material and laboratory supply management 3. Laboratory equipment maintenance and calibration 4. Cell Therapy document archival 5. Extending the above service to the external manufacturing site, as designated

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. The Cell Therapy Team of BeiGene is seeking highly motivated individuals to join and lead analytical assay development of cell products. A successful candidate for this position will be expected to have a solid background and hands-on experience in developing various bioassays to support release and characterization of cell therapy products. Also, a depth technical knowledge and experience in method qualification, validation, and transfer to internal or external partners is required. ROLE OVERVIEW The role will develop, transfer, and implement analytical methods, to understand and identify the general function, activity, characteristics, purity, stability, and safety of cell products. The role will work with process development and functional assessment team, and also participate in the decision of key quality attributes of cell products and identify the analytics in release certificate and product characteristics package in IND package. The role will develop, qualify and execute analytical methods for product release performed in QC laboratory. Also, he/she will utilize their technical expertise to ensure data is accurate and high quality under the GMP guiding principle. This position will work directly with key stakeholders to gather requirements, provide ongoing reports, and build relationships. RESPONSIBILITYIES 1. Develop accurate, precise and robust functional (e.g. flow cytometry, ELISA, Western) and molecular (e.g. ddPCR, RT-qPCR) analytical methods for in process control and final product release. 2. Design, test, and implement fit-for-purpose analytical assays to support the product quality and impurity characterization in cell therapy product development. 3. Perform and coordinate testing to support research development, process development, product stability, and method troubleshooting across functional groups. 4. Execute analytical method qualification and technology transfer to QC and partners. 5. Providing technical support to QC laboratories by performing QC testing as required and assisting in investigations. 6. Deliver development/technical reports, SOPs and test procedures. 7. Review and discuss analytical results and conclusions both orally and in writing. 8. Work in a team-based structure and interface with research and process development departments. 9. Maintain the analytical equipment master schedule for qualification/ requalification/ calibration and monitor the progress within AD and QC laboratories. 10. Maintain and ensure safe laboratory environment and work practices. 11. Ensure timely completion of testing and tasks as assigned. QUALIFICATIONS AND REQUIREMENTS 1. PhD with 3+ or 5+ yrs. experience in industry with a focus on bio-assay development, qualification cell and gene therapy products. 2. Extensive hands-on cell-based assay development experience. 3. Hands-on operation and data analysis experience with immune cell-based assay and flow cytometry (FACS) is required. 4. High level of proficiency in molecular biology (e.g. PCR, qPCR, ddPCR, RT-qPCR) is preferred. 5. Understanding of GMP concepts, ICH guidelines, method qualification and validation preferred. 6. IND experience, especially in cell therapy products, is preferred. 7. Strong desire to learn and troubleshoot technical challenges. 8. Collaborative mindset with strong communication skills, and the ability to effectively present data, write reports and document test procedures. 9. Excellent presentation skills, written and verbal. 10. Demonstrated ability to work in a highly collaborative team environment, coordinate tasks across multiple projects to meet deadlines. 11. Occasional weekend work may be required.

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. A successful candidate will be expected to have a solid background in cell biology, immunology, immune cell differentiation and expansion processes, scale-up, experience working in or supporting a cGMP-regulated environment, as well as sound technical knowledge of manufacturing processes for engineered immune cell therapies. ROLE OVERVIEW You will have high internal visibility focusing on developing robust and scalable manufacturing platforms for allogeneic cell expansion and directed differentiation. You will have the opportunity to establish manufacturing platforms and guide product development through all stages of development to ensure project advancement. This role will work with analytical development and R&D team to understand and identify the general function, activity, characteristics, purity, stability, and safety of cell products. The role will identify the manufacturing flow and key process parameters and execute clinical manufacturing activities to provide the required information in IND package. He/She will utilize their technical expertise to ensure data is accurate and high quality under the GMP guiding principle. RESPONSIBILITYIES 1. Design and execute phase-appropriate process development studies identifying process parameters and appropriate ranges to be assessed for optimal experimental design of the study 2. Design and execute DP process-enabling studies including formulation, fill/finish, cryopreservation, thawing, and in-use compatibility study of candidate cell therapy product. 3. Testing new manufacturing technologies and platforms in partnership with R&D. 4. Develop robust, scalable, directed-differentiation processes platform. 5. Be responsible for preparation of protocols, reports, test methods, and SOPs. 6. Review and discuss analytical results and conclusions both orally and in writing. 7. Work in a team-based structure and interface with research and process development departments. 8. Maintain and ensure safe laboratory environment and work practices. 9. Ensure timely completion of testing and tasks as assigned. QUALIFICATIONS AND REQUIREMENTS 1. Master with 3+ yrs. or 6+ yrs. of relevant experience in industry with a focus on in immune l culture, differentiation, expansion, formulation process. 2. Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes is required. 3. Hands-on experience with common cell therapy laboratory equipment and technology platforms (i.e. primary NK cells, iPSC-derived cell types, etc.) 4. Experience with cell culture bioreactor operations and process scale up with application to cell therapy is required. 5. Familiarity with flow cytometry assays and other cell-based characterization assays (i.e. cytokine release and cytolytic assays) is a plus. 6. Deep understanding of biologics industry process development strategies and best practices as applied from early development. 7. Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic. 8. Excellent presentation skills, written and verbal. 9. Occasional weekend work may be required. 10. Understanding of GMP regulations is preferred. BEIGENE GLOBAL COMPETENCIES When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. The Cell Therapy Team of BeiGene is seeking highly motivated individuals to join and lead analytical assay development of cell products. A successful candidate for this position will be expected to have a solid background and hands-on experience in developing various bioassays to support release and characterization of cell therapy products. Also, a depth technical knowledge and experience in method qualification, validation, and transfer to internal or external partners is required. ROLE OVERVIEW The role will develop, transfer, and implement analytical methods, to understand and identify the general function, activity, characteristics, purity, stability, and safety of cell products. The role will work with process development and functional assessment team, and also participate in the decision of key quality attributes of cell products and identify the analytics in release certificate and product characteristics package in IND package. The role will develop, qualify and execute analytical methods for product release performed in QC laboratory. Also, he/she will utilize their technical expertise to ensure data is accurate and high quality under the GMP guiding principle. This position will work directly with key stakeholders to gather requirements, provide ongoing reports, and build relationships. RESPONSIBILITYIES 1. Develop accurate, precise and robust functional (flow cytometry, ELISA, Western) and molecular (ddPCR, RT-qPCR) analytical methods for in process control and final product release. 2. Design, test, and implement fit-for-purpose analytical assays to support the product quality and impurity characterization in cell therapy product development. 3. Perform and coordinate testing to support research development, process development, and method troubleshooting across functional groups. 4. Execute analytical method qualification and technology transfer to QC and partners. 5. Providing technical support to QC laboratories, and assisting in investigations 6. Write development/technical reports, SOPs and test procedures. 7. Review and discuss analytical results and conclusions both orally and in writing. 8. Work in a team-based structure and interface with research and process development departments. 9. Maintain and ensure safe laboratory environment and work practices. 10. Ensure timely completion of testing and tasks as assigned. QUALIFICATIONS AND REQUIREMENTS 1. Master with 3+ or 6+ yrs. experience in industry or academia with a focus on cell and gene therapy products. 2. Extensive hands-on cell-based assay development experience. 3. Hands-on operation and data analysis experience with immune cell-based assay and flow cytometry (FACS) is required. 4. High level of proficiency in molecular biology (e.g. PCR, qPCR, ddPCR, RT-qPCR) is preferred. 5. Understanding of ICH guidelines, method qualification and validation preferred. 6. Strong desire to learn and troubleshoot technical challenges. 7. Collaborative mindset with strong communication skills, and the ability to effectively present data, write reports and document test procedures. 8. Excellent presentation skills, written and verbal. 9. Demonstrated ability to work in a highly collaborative team environment, coordinate tasks across multiple projects to meet deadlines. 10. Occasional weekend work may be required. BEIGENE GLOBAL COMPETENCIES When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. A successful candidate will be expected to have a solid background in cell biology, immunology, immune cell differentiation and expansion processes, scale-up, experience working in or supporting a cGMP-regulated environment, as well as sound technical knowledge of manufacturing processes for engineered immune cell therapies. ROLE OVERVIEW You will have high internal visibility focusing on developing robust and scalable manufacturing platforms for allogeneic cell expansion and directed differentiation. You will have the opportunity to establish manufacturing platforms and guide product development through all stages of development to ensure project advancement. This role will work with analytical development and R&D team to understand and identify the general function, activity, characteristics, purity, stability, and safety of cell products. The role will identify the manufacturing flow and key process parameters and execute clinical manufacturing activities to provide the required information in IND package. He/She will utilize their technical expertise to ensure data is accurate and high quality under the GMP guiding principle. This position will work directly with key stakeholders to gather requirements, provide ongoing reports, and build relationships. RESPONSIBILITYIES 1. Independently design and execute phase-appropriate process development studies identifying process parameters and appropriate ranges to be assessed for optimal experimental design of the study. 2. Independently design and execute DP process-enabling studies including formulation, fill/finish, cryopreservation, thawing, and in-use compatibility study of candidate cell therapy product. 3. Apply characterization methods for process development, establish process parameters, and contribute to CMC sections of regulatory filings. 4. Testing new manufacturing technologies and platforms in partnership with R&D. 5. Develop robust, scalable, directed-differentiation processes platform. 6. Be responsible for preparation of protocols, reports, test methods, and SOPs. 7. Review and discuss process and analytical results and conclusions both orally and in writing. 8. Work in a team-based structure and interface with research and analytical development departments. 9. Maintain and ensure safe laboratory environment and work practices. 10. Ensure timely completion of testing and tasks as assigned. QUALIFICATIONS AND REQUIREMENTS 1. PhD with 3+ or 5+ yrs. relevant experience in industry with a focus on in immune cell culture, differentiation, expansion, formulation process. 2. Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes is required. 3. Hands-on experience with common cell therapy laboratory equipment and technology platforms (i.e. primary NK cells, iPSC-derived cell types, etc.) 4. Experience with cell culture bioreactor operations and process scale up with application to cell therapy is required. 5. Deep understanding of biologics industry process development strategies and best practices as applied from early development. 6. Familiarity with flow cytometry assays and other cell-based characterization assays (i.e. cytokine release and cytolytic assays) is a plus. 7. Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic. 8. Excellent presentation skills, written and verbal. 9. Occasional weekend work may be required. 10. Understanding of GMP regulations is preferred.

The incumbent is responsible for set up and maintenance quality management systems to support BeiGene Cell Therapy, and ensuring adherence to supplemental local regulatory requirements. Essential Functions of the job: - Harmonize with BeiGene Global Quality Standard and changing regulations to achieve continual improvement to support BeiGene TW Cell Therapy. - Setting up and maintenance the quality management system for TaiWan Cell Therapy in compliance with BeiGene Global Quality Standard and US cGMP, PIC/S GMP and cGTP to support product development. - Manage governance and procedure document in QMSs and responsible the workflow of controlled document implementation. - Vendor management including handing vendor qualification process, vendor information maintenance, periodic review and follow up. - Responsible for controlled document archiving, issuing and maintenance such as controlled document/batch record issuing, label issuing, GXP document/record archiving, etc. - Assisting raw material qualification and release process such as checking record review, COA review, testing result review, and label issuing. - Assuring quality events such as change control, deviation, CAPA, risk assessment, compliant and recall are executed in time and compliant with SOP and regulatory requirement. - Assisting review and oversight on facility, equipment, instrument qualification and commission. - Assisting set up of quality control system such as instrument qualification, raw material specification, OOS, sample retention, etc. - Support quality internal audit to comply with BeiGene quality standard and ensure the GMP/GTP/GDP requirements are met during HA inspection. - Support and coordinate with Global Compliance for third Party WH and distributor qualification (typically for Cold-Chain products), ensure compliance of GDP activities. - Conduct GMP, GTP related training, to ensure operations of business functions are fully compliant with quality standard and regulations. - Review the quality event trend and KPIs, support the senior leadership to proceed quality oversight through Quality Management Review. Core Competencies, Knowledge and Skill Requirements: - In-depth knowledge of GMPs and GTP - Experience with regulatory compliance inspections - In-depth knowledge of quality principles, concepts, industry practices and standards on aseptic product - Knowledge of quality control on cell and gene therapy is a plus - Excellent verbal, written and interpersonal communication skills. - Ability to analyze and resolve issues calmly under tight timeline and uncertainty - Ability to work independently with departmental and interdepartmental subteams. Communication & Interpersonal Skills : - Good interpersonal skills, including listening, writing, negotiations, facilitation of discussions, possesses great attention to detail Experience: - 3+ year pharmaceutical or biotechnology industry GMP experience - Demonstrated experience in driving cross-functional project - Agility in change - Experience on tight timeline and uncertainty project of developing product is a plus - Experience of cell therapy is a plus - Experience on operation of quality control is a plus - Fluent English in spoken and written

Main roles/responsibilities 1. Design, execute, and analyze experiments related to iPSC editing, differentiation, and characterization. 2. Identify, optimize, and implement novel strategies for differentiating iPSCs. 3. Write and revise standard operating procedures for iPSC differentiation processes. 4. Prepare and conduct experiments for the generation and analysis of iPSC-derived cells, including the preparation of reports and test methods 5. Ensure timely completion of experiments, data analysis, and tasks as assigned. 6. Analyze data, monitor assay quality, troubleshoot, and present findings to project teams and research organizations. 7. Demonstrate accountability and flexibility in adjusting project objectives based on evolving project needs. 8. Collaborate with cross-functional teams to align iPSC cell therapy strategies with the company’s goals and project objectives. 9. Contribute to the development and execution of strategic plans for iPSC-based therapeutic applications, ensuring alignment with evolving project requirements. 10. Adapt research plans and priorities based on data insights, project milestones, and the company’s changing strategy. 11. Provide scientific guidance and adjust protocols as needed to meet dynamic project timelines and goals. Job Requirements 1. Ph.D. in Stem Cell Biology, Molecular Biology, Development, Immunology, Biochemistry, or related fields, with at least 2 years of industry experience. 2. Extensive laboratory experience in designing and conducting experiments, demonstrating strong problem-solving skills. 3. In-depth understanding of cell biology, molecular biology, cell therapy, and principles of cellular immunotherapy. 4. Proficient in molecular biology and cell biology techniques, including mammalian cell culture, flow cytometry, immunolabeling, ddPCR, and genomic analysis. 5. Willingness to work on weekends for iPSC cell culture and participate in rotating duty schedules. 6. Self-motivated, detail-oriented, and able to multitask effectively in a fast-paced, collaborative environment. 7. Strong independent thinking, troubleshooting skills, and excellent communication and teamwork abilities. 8. Strategic mindset with the ability to adapt research priorities to align with evolving project and company needs. 9. Demonstrated flexibility and problem-solving capabilities in responding to changes in project direction, timelines, and requirements. Technical/Skills Required 1. Commitment to continuous learning and acquiring new knowledge to meet job requirements. 2. Strong professionalism, ethical standards, and a sense of responsibility. 3. Ability to work under pressure and manage multiple tasks efficiently. 4. Self-motivated, hands-on, disciplined, detail-oriented, and proactive, with a strong team spirit. 5. Strategic thinking with the ability to adapt to shifting project demands and therapeutic goals. 6. Ability to balance scientific rigor with business objectives, aligning research strategies with company goals. 7. Flexibility in adopting new approaches and optimizing processes based on evolving scientific insights and market needs.

General Description: The Senior Manager/ Manager, GCP Inspection Management is responsible for implementing and maintaining a balanced, proactive, and phase appropriate approach to GCP Quality Assurance. This position will be primarily responsible for ensuring research and development activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards and practices. Also responsible for the organization, planning, process and logistics of all health authority inspections. Essential Functions of the job: Manage and oversee the GCP Quality Assurance activities: • Conduct and/or oversee the quality assurance (QA) inspection readiness activities related to FDA and ROW regulations across therapeutic areas and provide GCP guidance for all phases of drug development • Support and manage the inspection readiness activities and participate in managing regulatory health authority inspections. • Develop/improve and manage quality systems and processes to include: o Creation/revision of appropriate SOPs o Implementation and maintaining key QA systems, such as; investigations, Significant Quality Events (SQEs), Deviations, CAPAs, Audits, developing and managing integrated Quality Management Risk plans. o Supporting the activities related to the vendor management process training, SOPs, etc. o Supporting/managing pre-inspection visits at both investigator sites and vendors. o Conducting/managing review of key documents such as study protocols, informed consent documents, Investigator brochures, Clinical study reports, submission modules, etc. o Defining metrics and measures for GCP Quality Assurance to drive assessment and continuous improvement o Management and review of trends and report significant investigation/deviation issues and system deficiencies to senior management, as appropriate o Support and manage GCP Quality investigations o Coordinate and/or administer GCP training, as needed • Facilitate and manage inspection readiness meetings and represent Clinical Quality in meetings and discussions as needed • Develop a Managing Regulatory Inspections training program for the company and provide training on a periodic and as-needed basis • Participate in the review of study related metrics (i.e; protocol deviation, etc.) as part of Quality Management Risk approach to identify gaps, trends and the need for process improvements. • Promote continuous improvement • Expert knowledge of GCPs particularly FDA and ICH requirements • Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors • Ensure follow-up on all inspection commitments, responses, post-inspection activities, corrective and preventative actions, and resolve all issues for timely closure • Participate in vendor audits in accordance with BeiGene standard operation procedures, quality policies and/or plans • Create a central repository of all global/local regulatory inspection requirements and practices • Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment. • Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance • Proven ability in setting strategy for and driving quality process improvement initiatives • Strong leadership experience and mentoring skills • Strong global knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operations • Ensure all logistics are arranged for any Health Authority inspection (remote or on-site). • Other duties as assigned

About Us BeiGene is growing, and we are seeking new team members who are willing to take new challenges and exciting opportunities. The Foundation Cell Therapy Biology is at the forefront of advancing immune cell therapies to transform patient outcomes. We are seeking a highly motivated Scientist/Research Investigator to lead groundbreaking research focused on enhancing immune cell properties and developing novel cell therapy approaches. In this role, you will work collaboratively with genetic editing, iPSC differentiation, and immunology teams to pioneer new strategies that enhance effector cell function for next-generation immune cell therapies. The successful candidate will be responsible for designing and executing proof-of-concept immunological and biological experiments to validate these innovations, driving impactful scientific discoveries with direct translational potential for patients. This is an opportunity to contribute to cutting-edge scientific innovation in a dynamic, inclusive, and collaborative research environment. Key Responsibilities • Design, execute, and analyze immunological and biological experiments to enhance immune cell function, focusing on abT, gdT and NK cells. • Develop and optimize novel strategies to improve immune cell properties for clinical applications in cell therapy. • Collaborate closely with genetic editing and iPSC differentiation teams to integrate cutting-edge technologies into immune cell therapy development. • Establish and refine functional assays, including cytotoxicity, proliferation, cytokine release, and immune cell activation studies. • Apply advanced flow cytometry, cell sorting, and molecular biology techniques to optimize cell therapies. • Analyze experimental data, troubleshoot technical challenges, and refine research strategies to advance cell therapy programs. • Contribute to scientific publications, patents, and presentations at internal and external scientific meetings. • Work in a cross-functional and collaborative environment, fostering productive research interactions with internal and external teams. • Exhibit accountability and adaptability by adjusting project objectives in response to evolving research and development needs. Qualifications & Experience • Master’s degree in Immunology, Cancer Biology, Cell Biology, or a related field, with at least 2 years of industry experience. (Candidates with a Ph.D. will also be considered.) • In-depth understanding of cell biology, molecular biology, cell therapy, and cellular immunotherapy principles. • Strong expertise in immune cell biology, particularly abT, gdT and NK cells, iPSCs, or gene editing, is highly desirable. • Hands-on experience with flow cytometry, cell sorting, cytotoxicity assays, and functional immune assays. • Proven ability to work effectively in multi-disciplinary research teams, fostering productive collaborations. • Ability to work independently while demonstrating strong problem-solving, troubleshooting, and critical-thinking skills. • Excellent communication and presentation skills, with the ability to convey complex scientific concepts to diverse audiences. • Highly self-motivated, hands-on, and proactive, with a strong team-oriented mindset and commitment to scientific excellence. • Strong ability to multi-task and thrive in a fast-paced, collaborative environment. • Strategic thinker with the ability to adapt research priorities in response to evolving project and company needs. Why Join Us? • Work on cutting-edge research with direct clinical impact in the field of immune cell therapy. • Collaborate with world-class scientists and industry experts in a highly innovative and dynamic environment. • Enjoy a culture of inclusivity, teamwork, and scientific rigor with opportunities for professional growth and development. • Career development opportunities in a rapidly growing cell therapy sector. • Contribute to the next generation of cell-based immunotherapies.

General Description: The incumbent is responsible for Quality Control activities to provide support for the early-stage development and clinical production of Beigene’s Cell Therapy products, and ensuring adherence to supplemental local regulatory requirements. Essential Functions of the job: • Continuously build a highly efficient quality control laboratory. • Create, maintain and archive all QC documents, including specification, test methods, standard operating procedures (SOPs), quality agreements, and test reports, etc. • Establish and manage the raw material management system that encompasses setting raw material specifications, conducting release tests, and performing batch release. • Handle QC related quality events, such as OOS, OOT, change control, trend reports, etc. • Manage the test sample, reference standard and reagents. • Perform in - process control testing, final product release and Stability testing. • Oversee analytical equipment qualification and life cycle. • Set up and perform microbiological testing procedures for raw materials, in-process products and final products to ensure product safety and compliance with specification. • Work with contract testing lab and manage the out-sourced testing. • Review the specification document and testing report for material/cell bank/product release. • Plan and execute analytic method transfer, verification and validation. • Develop and implement a comprehensive environmental monitoring program. • Participate in department budget’s estimate and planning. Core Competencies, Knowledge and Skill Requirements • In-depth knowledge of PIC/S GMP, FDA, EMA, USP and EP guidance. • Experience with regulatory compliance inspections. • Knowledge of quality control on CGT is a plus. • Familiar with flow cytometry, cytotoxicity, ELISA, qPCR/dPCR, etc. • Knowledge of environmental monitoring and microbiological testing. • Excellent verbal, written and interpersonal communication skills. • Ability to analyze and resolve issues calmly under tight timeline and uncertainty • Ability to work independently with departmental and interdepartmental subteams. Communication & Interpersonal Skills • Good interpersonal skills, including listening, writing, negotiations, facilitation of discussions, possesses great attention to detail Experience • 3+year pharmaceutical or biotechnology industry GMP experience • experience in quality control in CGT is preferred • Experience in verification/validation of bioassay is plus • Experience in microbial control of CGT • Demonstrated experience in driving cross-functional project • Agility in change • Experience on tight timeline and uncertainty project of developing product is a plus • Fluent English in spoken and written

General Description: The incumbent is responsible for set up and maintenance of phase-appropriate quality management systems to support BeiGene CGT product development and ensuring adherence to global regulatory requirements. Essential Functions of the job: • Harmonize with BeiGene Global Quality Standard and changing regulations to achieve continual improvement to support BeiGene TW Cell Therapy. • Continually set up and maintain the phase-appropriate quality management system for TaiWan Cell Therapy in compliance with BeiGene Global Quality Standard and US cGMP, PIC/S GMP and cGTP to support product development. • Manage governance and procedure document in QMSs and responsible the workflow of controlled document implementation. • In collaboration with External supply quality team for vendor management. • Responsible for controlled document archiving, issuing and maintenance such as controlled document/batch record issuing, label issuing, GXP document/record archiving, etc. • Responsible for raw material qualification and release process such as checking record review, COA review, testing result review, and label issuing. • Handle quality events such as change control, deviation, CAPA, risk assessment, compliant and recall are executed in time and compliant with SOP and regulatory requirement. • Manage and review on facility, equipment, instrument qualification and commission. • Review batch record, test reports, EM record, ongoing stability data and so on to release/reject cell bank/final product. • Review the protocol and report of analytic method verification/validation. • Review the protocol and report of aseptic process/process validation • Monitor and negotiate with contract facility to ensure GMP compliance of their service. • Support quality internal audit to comply with BeiGene quality standard and ensure the GMP/GTP/GDP requirements are met during HA inspection. • Support and coordinate with Global Compliance for third Party WH and distributor qualification (typically for Cold-Chain products), ensure compliance of GDP activities. • Conduct GMP, GTP related training, to ensure operations of business functions are fully compliant with quality standard and regulations. • Review the quality event trend and KPIs, support the senior leadership to proceed quality oversight through Quality Management Review. • Participate in department budget’s estimate and planning. Core Competencies, Knowledge and Skill Requirements • In-depth knowledge of GMPs, GTP, FDA, EMA, USP and EP guidance. • Experience with regulatory compliance inspections • In-depth knowledge of quality principles, concepts, industry practices and standards on aseptic product • Knowledge of quality management on CGT • Excellent verbal, written and interpersonal communication skills. • Ability to analyze and resolve issues calmly under tight timeline and uncertainty • Ability to work independently with departmental and interdepartmental subteams. Communication & Interpersonal Skills • Good interpersonal skills, including listening, writing, negotiations, facilitation of discussions, possesses great attention to detail Experience • 5+ year pharmaceutical or biotechnology industry GMP experience • 2+ years’ experience in quality management of CGT • Demonstrated experience in driving cross-functional project • Agility in change • Experience on tight timeline and uncertainty project of developing product is a plus • Fluent English in spoken and written

工作概要： 實驗室清潔技術員負責維持一般研究區域及細胞培養室的清潔。 該職位需確保所有區域依據實驗室標準程序和感染控制措施進行消毒，處理日常清潔任務，並遵循特殊操作區之生物安全管制規範（BSL-2）。 主要職責： • 執行日常清潔和消毒，包括實驗台、地板、垃圾處理區域和設備等的一般實驗室區域。 • 按照BSL-2等級生物安全規範清潔和消毒病毒室。 • 維護清潔紀錄，確保依時完成清潔排程。 • 處理生物危害廢棄物，確保按照安全規定正確處置。 • 按照正確的稀釋比例和使用方式操作清潔化學藥品，並遵守安全預防措施。 • 日常檢查並補充洗手消毒液、醇類消毒液、純水、玻璃與塑膠耗材、手套及其他個人防護裝備。 • 支援日常維護工作，並向實驗室經理報告設施或設備問題。 • 遵循所有針對BSL-2區域的安全和感染控制指引。 資格要求： • 高中畢業或同等學歷。 • 至少1年清潔或維護工作經驗，實驗室或醫療環境經驗者優先。 • 熟悉生物危害廢物處理及基本感染控制程序。 • 能夠遵循詳細指示，並保持高標準清潔。 • 具備基本的化學品使用和安全數據表（SDS）知識。 • 注重細節，具獨立工作能力。 • 能夠執行體力要求較高的清潔任務（如搬運、彎腰、長時間站立）。

工作概要： 專業清潔技術員負責對高安全性區域（包括動物設施及GMP級潔淨室）進行關鍵的清潔、消毒及無菌維護。 該職位需具備對嚴格的穿戴程序、無菌技術及使用專業清潔劑的知識，以確保無菌和無污染的環境。 主要職責： • 按照嚴格的無菌程序執行GMP潔淨室的日常清潔和消毒。 • 清潔動物設施，確保遵循高等級污染控制措施，徹底消毒表面。 • 在動物及GMP區域遵循穿戴程序，包括全身防護服、口罩、手套和靴套。 • 使用符合GMP標準的清潔材料和無菌溶液清潔牆面、地板、設備及空氣過濾系統。 • 執行潔淨室及動物設施的環境監測，評估微生物負荷、顆粒水平及潔淨度。 • 日常檢查並補充洗手消毒液、醇類消毒液、純水、玻璃與塑膠耗材、手套及其他個人防護裝備。 • 維護詳細的清潔活動紀錄，並確保符合GMP規範。 • 處理動物廢物並消毒與動物測試相關的設備。 • 定期檢查並記錄設備的清潔狀況和功能性。 • 與實驗室經理及質量保證（QA）人員合作，確保遵循法規清潔標準。 資格要求： • 高中畢業或同等學歷（技術或科學相關領域的副學士及學士學位者優先）。 • 至少1年清潔或維護工作經驗 • 具有實驗室或醫療環境的清潔消毒經驗者優先。 • 具有潔淨室或動物設施的清潔消毒經驗者優先。 • 具GMP或類似受監管環境經驗者優先。 • 能遵守GMP規範、無菌技術及潔淨室相關的法規標準。 • 能夠遵循嚴格的穿戴程序及無菌操作規範。 • 具備處理和應用專業消毒劑及滅菌技術的經驗。 • 熟悉環境監測程序及污染控制措施。 • 注重細節，具備解決問題的能力，並能在高污染控制區工作。 • 能夠在穿戴全套個人防護裝備的情況下長時間工作並執行體力任務。

About the Role BeOne Medicines is seeking an enthusiastic and highly motivated Senior Research Investigator / Senior Scientist with expertise in gene engineering and genome analysis to join our Cell Therapy team. The successful candidate will play a key role in developing innovative genome engineering platforms to advance next-generation cell therapies. This role is responsible for leveraging the company’s proprietary technologies to design and deliver cutting-edge engineered cell products for clinical applications. Key Responsibilities • Design, execute, and optimize gene engineering strategies (e.g., targeted knock-in/knock-out, transgene integration, advanced editing technologies) in mammalian cells to meet project goals. • Independently derive, screen, and characterize engineered clones with strong hands-on execution, integrating molecular biology and genome analysis, while supporting routine lab maintenance to ensure efficient workflows. • Support NGS-based analyses (Illumina etc.) to evaluate desired modifications and genome stability. • Collaborate with bioinformatics, discovery, and development teams to deliver high-quality engineered cell therapy products. • Present scientific data and engage colleagues in technical discussions at internal project meetings. • Maintain a strong laboratory presence and contribute to an innovative, collaborative team environment. Qualifications Required: • PhD in Molecular Biology, Gene/Genome Engineering, Immunology, bioinformatics or related biological sciences with ≥3 years of relevant experience. (academic experience post-graduate also considered) • MS in Molecular Biology, Gene/Genome Engineering, Immunology, bioinformatics or related biological sciences with ≥5 years of relevant experience. • Proven hands-on experience with gene engineering technologies (e.g., CRISPR, viral vector, TALEN, mRNA delivery platforms) in mammalian cells (e.g., knock-in/out, transgene insertion, targeted modifications). • Strong molecular biology skills (e.g., cloning, PCR/qPCR/dPCR, Sanger sequencing, NGS analysis). • Knowledge or experience in developing and characterizing engineered cells. • Demonstrated ability to work in a dynamic, fast-paced environment with strong teamwork and problem-solving skills. • Excellent organizational and communication skills; proven ability to manage multiple projects under tight timelines. Preferred: • Experience with engineered cell therapy or gene therapy development (iPSC, MSC, T cells, NK, stem cell). • Familiarity with bioinformatics, pathway analysis, or NGS data interpretation. • Experience with advanced molecular biology techniques and flow cytometry. • Knowledge of genome analysis approaches for engineered cell therapy products.