We strive to create a friendly and vibrant workplace where employees bring their talent into full play and reach common goals. GenFleet is expected to become a real fleet of creative capacity and efficient execution, moving forward in the boom of innovative drug development that will revolutionize the prospects of the pharmaceutical industry.
Annual group tours
Granted on traditional festivals and birthdays
Annual leave and sick leave
Entry checkup, occupational body test and annual physical examination
For lunch, transportation and telecommunications
With extra insurances other than standard policies formulated by the government
1. Responsible for leading small molecular drug discovery projects in immunology and oncology；
2. Responsible for designing, executing and reporting the results of experiments to support small molecular drug discovery projects from target validation to clinical candidate selection and IND filing. In-depth understanding of project biology with strong science driven thinking；
3. Lead in vitro teams. Design, develop and validate drug screening assay and MOA studies. Be responsible for the data quality and optimize the workflow；
4. Participating in the evalsuation and studies of in-licensing opportunities or collaborative research for small molecular drug projects.
1. PhD degree in immunology, cell biology, biochemistry or a relevant discipline, with at least 6 years working experience in pharmaceutical industry;
2. Experience in leading small molecular projects; be familiar with designing enzymatic and cell-based assays for drug screening and MOA studies. Experience in IND enabling studies is preferred;
3. Excellent written and verbal communication skills in both English and Chinese are required;
4. Extraordinary flexibility and ability to think independently but work collaboratively within a big multidisciplinary matrix team of a fast-growing biotechnology organization.
1. Responsible for leading antibody/biologics drug discovery projects in immunology and oncology；
2. Responsible for designing, executing and reporting the results of experiments to support antibody/biologics drug discovery projects from target validation to clinical candidate selection and IND filing；
3. In-depth understanding of project biology with strong science driven thinking；
4. Lead biological in vitro teams. Design, develop and validate biological functional assays. Be responsible for the data quality and optimize the workflow；
5. Participating in the evalsuation and studies of in-licensing opportunities or collaborative research for antibody/biologics drug projects.
1. PhD degree in immunology, cell biology, biochemistry or a relevant discipline, with at least 6 years working experience in pharmaceutical industry;
2. Experience in leading biologics projects; be familiar with antibody designing and cell-based assays for antibody candidates selection. experience with immunooncology ex vivo or in vivo assays is a plus;
3. Excellent written and verbal communication skills in both English and Chinese are required;
4. Extraordinary flexibility and ability to think independently but work collaboratively within a big multidisciplinary matrix team of a fast-growing biotechnology organization.
1. Be responsible for developing the formula and it relative planning, completion and evalsuation, including early toxicology formulation, API crystallization and salt formation study, clinical formulation screening and design, packaging design, shipping condition and stability monitoring of the product;
2. Conduct the scale up and tech transfer to pilot batch manufacturing, clinical batch manufacturing and pre-marketing PPQ batch manufacturing activity in the future;
3. Manage the project and optimize the development flow.
1. Pharmaceutics or related degree and more than 8 years of industrial experience for master degree and 5 years of industrial experience for Ph.D;
2. Familiar with oral solid and injection dosage forms and corresponding preparation skills, with industrial experience is preferred;
3. Familiar with regulatory and technique guidance, and be able to write formulation related documents in CTD format;
4. With strong conscientiousness and can lead the team, have good communication skills and implementation capability, hard working and innovative.
1. To achieve the department and company goal, establish the analytical development plan and budget for instrument purchase, monitor and control the implement of the annual work plan, be responsible for the project completion;
2. Be responsible to set up the quality system of the analytical lab and establish or optimize the operation procedure;
3. Be responsible to trouble shooting the technique challenge and organize the team to overcome it; guide, train and encourage the team;
4. Take responsibility in method development, specification establishment, submission docment preparation; proof reading of the regulatory material, spectrum analysis and original documentation, confirm the overall accuracy, completeness, and consistency of data integrity and cooperate with the authority’s inspection;
5. Be responsible for the technique transfer, review the transfer report, manage the GMP manufacturing and CRO/CMO.
1. Ph.D of pharmaceutics, analytical major or equivalent education level;
2. More than 7 years of big pharmaceutical company experience related to analytical and quality work;
3. Be expert in newest analytical technology, able to master the analytical development trend and has unique understanding of the key techniques; expertise in API and formulation’s quality standards;
4. Master the regulatory and technique guidance for China and FDA, be familiar with the regulatory submission procedure and technique requirements;
5. Strong conscientious and collaborative spirit.
1. Responsible for the profile design of trials related to preclinical toxicology;
2. Responsible for protocol and report review, process supervision;
3. Coordinate the cooperation with CROs, manage the progress of toxicology project, and ensure that all experiments are completed as planned;
4. Assist in preparing IND application materials, cooperating with RA to complete IND application.
1. Major in pharmacy or biology;
2. At least 2 years of preclinical R & D experience or project management experience;
3. Proficient in reading relevant English professional paper;
4. Good communication skills, strong innovation and learning ability, competent for challenging work.
1. Contribute to the selection of potential investigators;
2. Initiate, monitor and close study sites in compliance with Procedural Documents, protocol, ICH/GCP Guidelines and other local regulations as applicable;
3. Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations both in the office and at site;
4. Drive performance at the sites. Proactively identify study-related issues and escalates as appropriate;
5. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented.
1. Bachelor’s degree or equivalent in a scientific or health-related field;
2. CRA I: 1 year of relevant clinical research experience and/or relevant educational experience.
3. CRA II: 2-3 years of relevant clinical research experience, able to work independently;
4. Senior CRA: about 3 years of monitoring experience. Demonstrate leadership skill, mentor and coach capability;
5. Oncology trial experience preferred. Excellent knowledge of international guidelines ICH/GCP;
6. Fluent knowledge of spoken, read and written English is preferred
Shanghai Zhangjiang / Beijing / Guangzhou / Hangzhou / Wuhan / Changsha / Chengdu / Suzhou / Nanjing
