1. Responsible for managing and supporting the daily operation of the laboratory, such as the management of samples, laboratory consumables and reagents, and the management of purchasing, receiving, numbering, warehousing and warehousing;

2. Manage reagents that are easy to produce drugs and explosives, and the management shall comply with relevant laws and regulations; To be responsible for the management of hazardous chemicals in the chemical laboratory and the docking with the regulatory authorities, as well as the management and removal of hazardous wastes;

3. Assisted the company in construction projects, and conducted deployment and process supervision for the overall project; Ensure progress, quality, cost control and completion of project tasks;

4. Make good contact with the external project, balance the relationship and maintain a good construction environment; Responsible for dealing with the major problems on site.

5. Responsible for equipment management, including equipment selection, purchase, installation, commissioning, verification and other equipment life cycle management

6. Responsible for drafting, revising and implementing SMP and SOP documents of facilities and equipment, formulating and implementing annual maintenance and renovation plans of new projects;

7. Responsible for safety management and training of laboratory EHS to ensure safety and compliance of research and development work;

8. Assisted various departments of the company in overall coordination and coordination of internal and external relations;

9. Responsible for completing other affairs arranged by the leader (including emergencies).

Salary: S$3,500.00 - S$7,000.00 per month

Job Description

• Responsible for the R&D of CAR-T cell therapy in the treatment of hematological tumors and solid tumors during the preclinical stage.
• Responsible for implementing molecular biology, cell biology and immunology related experiments, including molecular cloning, gene knockout and knock-in, lentiviral packaging, isolation of immune cells, CAR-T cell preparation, ELISA, and FACS and other techniques for functional evaluation and analysis.
• Analyze experimental results and report research findings and issues.

Requirements

• Master's degree or above in biology-related majors, with experience in cell biology, molecular biology, immunology and CAR-T is preferred
• Familiar with conventional molecular and cell biology experimental skills are preferred, including molecular cloning, gene editing, cell culture, lentiviral packaging, FACS, ELISA and other techniques
• Practiced and rigorous research and development attitude; strong scientific abilities, strong curiosity; capability to analyze and solve problems independently
• Strong sense of responsibility, proactive during work, good at communication, be able to cooperate with others

Job Description

• Development of molecular detection methods in R&D and production of CAR-T cells; Develop project management plans for clinical trials and take full responsibility for managing clinical trial progress, budget, and risk throughout clinical trials; implement project resource strategies to ensure project success and deliver project goals.
• Responsible for evaluating, selecting and establishing partnerships with clinical trial sites and centers. Signing cooperation agreements; ensuring that clinical trials are carried out smoothly within the planned time frame.
• Responsible for supervising the implementation process of clinical programs, actively managing the activities and outputs of multiple clinical trial partners, and ensuring efficient and timely delivery of high-quality data in clinical trials.
• Effectively manage and lead suppliers of outsourcing projects to ensure that they can deliver on time and meet key milestones.
• Identification of problems that occur within clinical operations and active coordination of their resolution.
• Responsible for ensuring that the operation of the clinical project complies with the requirements of relevant laws, ICH-GCP and SOP, ensuring that the project can respond to the audit at any time during the operation, and the requirements put forward during the verification process.

Requirements

• Bachelor degree or above in pharmacy, clinical medicine, nursing and other related majors
• 3+ years of relevant experience
• Have multiple full project management experience or multiple clinical trial projects
• Familiar with GCP, National Food and Drug Administration (NMPA) and other relevant regulations
• Experienced in cell therapy, tumor therapy, immunotherapy, etc.
• PMP certificate is preferred

Job Description

• Assist in the management of clinical research centers, conduct research center screening, start-up, monitoring and closing visits, etc., ensure that the trial meets GCP requirements, trial protocols and departmental SOP.
• Promote the process of project establishment, academic review, ethical review, HGRAC, research filing and contract signing of clinical trials in each research center.
• Regularly commun4icate with the research center, organize relevant meetings, conduct program and research-related training for the research center, implement project requirements and solve problems of the research center.
• Formulate the project monitoring plan of our center, complete the monitoring according to the project monitoring plan and department SOP, submit the monitoring report in time, communicate the problems found, ensure the quality and progress of the clinical trial.
• Follow up the research center subject enrollment, CRF completion and data management, manage the research center's work progress; evaluate the research center's work quality, and determine whether the research center conducts research in accordance with the program and applicable regulations.
• Create and maintain the relevant documents of the research center, complete the visit report and other research documents on time.
• Cooperate with the GCP audit and rectify the existing problems in time.
• Report the standing of the research center to PM and/or direct manager, and communicate and collaborate with other departments.
• Establish and maintain a good relationship with the clinical trial research center and the research team.
• Monitor CRC's work progress and quality.
• Assist in the management of CRO, SMO, central laboratories, insurance brokerage companies and other suppliers.
• Assist the supervisor to control the trial budget.

Requirements

• Junior college or above, major in medicine, nursing, pharmacy or biology
• Familiar with ICH-GCP and related regulations; more than 1-2 years of formal clinical trial management experience in pharmaceutical companies or CRO companies experienced in oncology drugs or cell therapy projects
• Proficient in using Word, Excel, Powerpoint and other software to complete tasks
• SCRA requires 3 years or more of work experience; CRA requires 1 year or more of work experience

Job Description

• Assist others researchers in the research center to complete various tasks according to the applicable SOP, work authorization and experimental plan.
• Assist in the completion of ethical data submission, institutional filing and contract signing, etc., and aid the start up of the research center.
• Assist the researcher to complete the collection, arrangement and filing of documents of the research center in each stage of the trial.
• Assist in the training of other researchers and clinical trial participants, such as nurses and laboratory technicians.
• Assist the researcher to complete the processing, preservation and transportation of the test samples.
• Assist the researcher to complete the management and counting of clinical research drugs and related materials, including the receipt, preservation, distribution, recovery and return of drugs and related materials, and complete relevant records.
• Under the authorization of the researcher, assist the researcher to fill in the case report form and resolve any differences (other than those requiring medical judgment). assist in the timely completion of relevant safety reports such as SAE and SUSAR.
• Coordinate the monitoring and auditing work of the research center, and prepare various documents in advance to cooperate with the monitoring and auditing.
• Conduct comprehensive communication (email, oral, fax, meetings) with the center personnel and the sponsor according to the trial plan and record relevant information.
• Assist in the closure of research centers, in the recovery of experimental drugs and research materials, and in the filing of research materials. and submit them to an ethics committee or other institution.

Requirements

• Junior college degree or above, clinical medicine, nursing and other medical related majors
• Have clinical medical or nursing work experience, more than 1 year of CRC work experience, familiar with clinical trial related processes experience in oncology drug or cell therapy projects
• Proficient in using Word, Excel, Powerpoint and other software to complete tasks