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ADC coupling production engineer
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.

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Cell Fermentation Engineer
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.

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Registration Specialist
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.

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Pharmacovigilance specialist
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.

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Pharmacokinetics researcher
Pharmacokinetics   researcher1. 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.

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CTA1. 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.

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    369 Qiaoxin Road, Qiantang District, Hangzhou 310018 Zhejiang, China
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