Job Description

• Assist the company in the management of the project in the hospital, ensure smooth communication and good relationship with researchers, institutional personnel, and ethics personnel in various centers. Maintain a good cooperative relationship with internal and external departments.
• Assist in the collection, processing, preservation and transportation of specimens.
• Assist in gathering, sorting and filing management of the project data from the hospital; track and report adverse events and serious adverse events during the experimental research process to protect test subjects’ rights and interests.
• Manage the experimental materials in the hospital, check and report the progress and quality of the test, fill in the medical records, recovery of the experimental drugs, respond to adverse drug reactions, etc., find problems, analyze problems, propose solutions and implement them.
• Responsible for the execution and supervision of the center's clinical trials, ensure that the project is carried out in accordance with the national GCP requirements, the test plan and the company's standard operating procedures, and quality control the entire process.

• Bachelor degree or above, 1-5 years of work experience; Medicine and pharmacy related majors
• Familiar with the clinical monitoring process, able to carry out various monitoring and related work independently
• Proficient in using WORD, EXCEL, PPT and other office software
• Good written and oral communication skills, coordination and plan execution skills; service awareness and customer-centric potential
• Ability to communicate effectively; strong affinity; assimilation skills; ability to establish and maintain good working relationships with various types of people

Job Description

• Preparation of CAR-T cells (medium preparation, cell isolation, transduction, expansion, cryopreservation, etc.), including process development, IIT and IND production experiments.
• Complete the filling of the experimental record and daily record form.
• Assist the technical supervisor to complete the preparation of SOP documents and record forms.
• Assist the technical supervisor to complete the data collation of process development and production.
• Assist the technical supervisor in the training of new personnel.

Requirements:

• Bachelor degree or above in cell biology, immunology and other biological related majors
• More than 2 years of GMP work experience, experience in CAR-T cells, immune cells, stem cells, mammalian cells, etc. is preferred
• Proficient in animal cell culture aseptic manipulation techniques (Ficoll separation, cell expansion, transfection, sampling and counting, microscope observation, etc.)
• Proficient in the operation of cell culture and analysis related equipment (biosafety cabinet, CO2 incubator, microscope, centrifuge, flow cytometer, etc.)

• Responsible for the inspection of purified water for pharmaceutical use; including but not limited to the testing of samples for intermediate control, release samples and stability studies.
• Strictly implement the inspection operation rules and management rules, fill in the original records according to the specifications, and be responsible for the original data.
• Responsible for the mutual review and re-inspection between the inspectors of the post.
• Responsible for the verification and documentation of physical and chemical inspection methods.
• Participate in the implementation of other physical and chemical analysis projects，in process validation and equipment cleaning validation.
• Post will involve HPLC method validation and development (using HPLC to detect cells, viruses, plasmids, etc.).

• Junior college degree or above, Medicine and pharmacy related majors
• Have more than 2 years of QC inspection work experience in GMP pharmaceutical production enterprises
• Proficiency in the use of conventional laboratory instruments such as UV, pH meter, conductivity meter, TOC meter, etc.
• Good communication skills and teamwork spirit
• Good execution ability and complete the relevant work arranged by the leadership in a timely and high-quality manner

• Responsible for summarizing and interpreting the requirements of drug registration regulations and technical guidelines, and providing compliance guidance and risk management for company R&D.
• In accordance with the company's project establishment and R&D plans, formulate the company's product registration annual plan, and oversee its implementation;
• Establish a drug registration work system and procedures to ensure that the project is completed in a timely manner within the specified time.
• Responsible for drug registration application, follow-up coordination and registration document management.
• Responsible for coordinating FDA, CFDA experts and pharmaceutical experts to solve regulatory and registration issues during the drug development and registration process.
• Responsible for tracking and collecting the policies and regulations of domestic and foreign drug administrations, and timely summarizing, classifying, sorting and archiving various pharmaceutical regulations, documents and technical data issued by the regulatory authorities.
• Responsible for the review of registration documents, propose solutions for key issues in registration applications, and coordinate the relevant departments to solve problems.
• Responsible for the daily contact and communication with external regulatory authorities and review agencies at all levels.

• Master degree or above in pharmacy or related majors
• More than 5 years of relevant work experience in drug registration, and with successfully biopharmaceutical drug application experience, are preferred
• Familiar with the relevant laws and regulations of drug registration and application process, and have the ability to coordinate and solve various problems related to registration in R&D
• Familiar with the writing of application materials, and have the ability to coordinate and review drug registration application materials
• Be able to consult relevant literature from both domestic and abroad , and have good writing skills in both Chinese and English

Job Description

• Introduce advanced cell diagnosis and treatment products and technologies.
• Cooperation with other companies and organizations.
• Business negotiations and business contracts.

Requirements

• Bachelor degree or above in pharmaceutical research related major, master degree and doctor degree are preferred
• More than five years of experience in pharmaceutical R&D related industries, with both foreign and domestic industry experience, successful project establishment experience is preferred; successful deal experience is preferred
• Possess leadership, good communication skills and team coordination skills, and can actively mobilize internal and external resources to promote the project process
• Have business acumen and market insight, an ability to gather, integrate and process information, and the ability to adapt to ever-changing circumstances in the business environment