| ADC coupling production engineer | 1. Responsible for the production and validation of GMP pilot sample of antibody conjugated drugs; 2. According to the requirements of new drug application, prepare the research report on the coupling and purification process of antibody drug conjugation, process procedures, batch production template, process-related application materials and other documents; 3. Familiar with GMP, NMPA, FDA, EMA, ICH and other guidance regulations; 4. Assist daily management and manage new employee training. | 1. Full-time bachelor degree or above, major in organic chemistry, chemical engineering, biochemistry, pharmaceutical engineering or related; 2. Experience in antibody drug coupling and purification. Familiar with GMP regulations. |
| Cell Fermentation Engineer | 1. Responsible for the process development and pilot scale up of SHAKING flask and reactor culture of CHO cells; 2. Record the culture experiment records in detail and write the summary report of culture process development; 3. Write the application materials related to the process according to the requirements of new drug application; 4. Write standard operating procedures related to CHO cell culture; 5. Maintain CHO cell culture bioreactor. | 1. Full-time bachelor degree or above, major in pharmacy, bioengineering, biochemistry, pharmaceutical engineering, fermentation engineering or related; 2, have CHO cell culture and other related professional knowledge and skills; 3. Familiar with mammalian cell large-scale culture process; 4.Familiar with bioreactor process development and scale-up; 5. Good English level and literature retrieval ability; 6, hard-working, proactive, strong learning ability, team spirit, high sense of responsibility, excellent writing and good communication skills, obey the work arrangement. |
| Registration Specialist | 1. Familiar with domestic, European and American drug registration laws and regulations, as well as GMP production and management regulations; 2. New drug registration application for developed drugs in accordance with relevant national laws and regulations; Responsible for the registration of the company's related drugs, according to the application requirements to write the relevant application technical documents; 3. Prepare DMF in eCTD format according to domestic and foreign drug registration regulations. 4. Responsible for domestic and foreign application of drug documents, data supplement, change, annual report submission, etc.; 5. Maintain good communication with production department and inspection department to promote the smooth progress of project work; 6. Report work progress regularly and assist leaders to carry out other work. | 1. Bachelor degree or above, major in biology, chemistry, pharmacy or related; 2.Biologic drug development or registration experience is preferred; 3. Familiar with drug Administration Law, Drug Registration Administration Measures, ICH related guidelines, the whole process of drug research and development, and the workflow of drug registration. |
| Pharmacovigilance specialist | 1. Input, code and preliminary evaluation of individual case reports according to laws and regulations such as NMPA/FDA/ICH/GVP, guidelines and SOP of the company, such as medical code, severity, anticipation and case description; 2. Conducte consistency check and quality control for individual case reports; follow-up; 3. Investigation of death cases and group safety incidents; Participate in the evaluation of adverse reactions and the correlation between drugs and suspected adverse reactions; 4. Supporte the start of clinical projects, assisted in the formulation of key drug monitoring programs, implemented, managed, wrote and reviewed pharmacovigilance agreements or contracts, and trained relevant personnel; 5. Consult literature regularly, be skilled in using database, assist in signal evaluation and monitoring, master product field or product knowledge, especially safety information, and provide basis for relevant decisions; 6.Familiar with the latest regulatory guidelines of China, US, EU and international organizations such as ICH, CIOMS, write and update the company's pharmacovigilance SOP, participate in supporting the company's internal, external and regulatory inspection. | 1. Bachelor degree or above in medicine, pharmacy, epidemiology or related field; 2.More than 1 year of pharmacovigilance related working experience is preferred; 3. Self-motivated, responsible, good team spirit, strong pressure resistance; 4. Good communication, strain ability and problem solving ability; 5. Good English listening, reading and writing skills. |
| Pharmacokinetics researcher | 1. The quantitative pharmacology software was used to analyze PK and PD data, and the PKPD model and population PK study were established; 2. Apply software to analyze non-atrioventricular model and atrioventricular model; 3. Prepare regulatory submissions for clinical pharmacology components; 4. Clinical pharmacologically related program design, data analysis and results analysis, and optimization of PK blood collection and dose administration; 5. Write abstracts and manuscripts for external presentation and publication. | 1. Master's degree in pharmacy, biological sciences, Statistics, Mathematics, Physics, chemical Engineering, medical engineering or other related sciences; 2.Familiar with R language and NONMEM WinNonlin or other modeling and simulation software is preferred; 3. Experience in drug development is preferred, and knowledge of GLP specification is preferred; 4. Training in pharmacokinetic data analysis is required; 5. Strong analytical and technical writing skills, good written and oral communication skills and organizational skills. |
| CTA | 1. Assist PM to manage trial related documents, such as collection, scanning, copying, archiving and maintenance of clinical trial research data; 2. Cooperated with PM to collect information of various research institutions and update the project management Tracker; 3. Assisted in the management of test materials, and completed the release, recovery and destruction of project materials after the approval of the project manager; 4. Cooperate with PM in contract management of the project, and assist in payment and other processes; 5. Participate in the coordination of clinical trial related meetings and training, such as the arrangement and minutes of research meetings; 6. Other tasks assigned by superior leaders. | 1. Bachelor degree or above, major in medicine or related; Experience in CRC and CTA is preferred; 2. Careful, serious, strong sense of responsibility; Proficient in computer and office software; 4. Strong communication, coordination and language expression skills. |
