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.
?Summer is not just about scorching sun rays and the season ignites excitement in people. At the height of heat wave, GenFleeters just finished its first summer sports games and let's take a look at these memorable moments!
Children's Day is not only for adults to recall good old days, but also a great chance to usher in new hopes~
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. Complete the routine sample testing of API and preparation
2. Complete the development, validation and transfer of analytical methods under the guidance of the superior
3. Participate in the maintenance of analytical instruments, assist in troubleshooting, control and manage analytical instruments through regular maintenance and preventive maintenance
4. Standardize the research according to the requirements, make the relevant original records, sort out and file the data, and write the research report
5. Carry out other work arranged by superiors
1. Specializes in pharmacy, chemistry and pharmaceutical engineering, bachelor degree or above
2. One year or more working experience, have good chemical analysis experiment operation ability, and can skillfully use common analytical instruments and equipment, such as HPLC, LCMS, etc., familiar with GC, MS and other common drug analysis technology
3. Careful, cautious, strong sense of responsibility, good team spirit, good communication skills and work execution
1. Participate in the preparation of Sino US ind / BLA / NDA pharmaceutical application materials, pharmaceutical annual report, pharmaceutical change and reply to defect letter or supplement
2. Assist the project leader to track the progress of project R & D and application, coordinate the collection and audit of relevant documents related to product registration and application
3. Responsible for the retrieval and translation of drug registration related literature
4. Finish other related work arranged by superiors
1. Bachelor degree or above in pharmacy, chemistry, biopharmaceutical, etc
2. One year or more experience in pharmaceutical research and development is preferred
3. Be familiar with drug registration management methods and corresponding laws and regulations
4. Good execution ability
5. Strong interpersonal communication ability and organization and coordination ability
1. Independently complete the literature review and atlas analysis, and complete the preliminary design of compound synthesis route according to the literature
2. Skillfully complete the chemical reaction, make a more comprehensive analysis of the results, and complete the research projects with certain difficulty under the assistance
3. Complete the experiment record and report clearly and completely
4. Proficient in literature and patent retrieval
5. Carry out other work arranged by superior
1. Master degree or above, major in organic chemistry, pharmaceutical chemistry or related
2. At least 3 years working experience in chemical synthesis, familiar with organic synthesis operation, with strong ability of analysis and problem solving
1. Independently complete the literature review and atlas analysis, complete the preliminary evaluation of compound synthesis routes according to the literature, identify potential problems, and provide constructive solutions
2. Complete the route synthesis work related to the project in time, and make a more comprehensive analysis of the results, and can complete the research projects with certain difficulty independently or with assistance
3. Complete the process R & D work related to the project, be responsible for the internal and external transfer and amplification of the process in the later stage, follow up the progress of the project, summarize the problems in the amplification in time and give feasible solutions, so as to ensure the smooth progress of amplification production
4. Proficient in the application of organic synthesis separation and purification, identification and analysis technology to support process development and route optimization
5. Technical assistance to guide subordinate members to complete assigned project work
6. Complete the project related experiment record timely and accurately, prepare technical report, update or archive regularly
7. Finish technical documents timely and with high quality to meet internal or external quality requirements
8. Carry out other work assigned by superiors
1. Master degree or above 1. Master degree or above, major in organic chemistry, pharmaceutical chemistry or related
2. At least 3 years working experience in chemical synthesis, process R & D, optimization and transfer amplification, familiar with organic synthesis operation
3. Good at finding problems, with strong ability to analyze and solve problems independently
4. Good communication and feedback skills, have the courage to speak up, have a sense of responsibility and teamwork spirit, education background, organic chemistry, pharmaceutical chemistry and related majors
1. DMPK and Clinical Pharmacology representative on clinical and study teams and works in close collaboration with multidisciplinary team to progress drug candidates from research-to-development transition through preclinical and clinical development to successful approval.
2. Responsible for the design, planning, oversight as well as the analysis, interpretation and reporting of results of DMPK studies.
3. Responsible for the design, planning, oversight as well as the analysis, interpretation and reporting of results of Clinical Pharmacology studies.
4. Interfaces with discovery research colleagues during pre-clinical stages of development to plan and ensure sufficient PK/PD knowledge exists for translation to clinic.
5. Applies scientific knowledge and experience to cover a breadth of areas including the design, execution, and interpretation of ADME, CYP inhibition/induction, transporter, PK/PD and clinical pharmacology studies.
6. Applies quantitative skills to support model-based drug development and address complex issues via modeling and simulation.
7. Responsible for DMPK and clinical pharmacology contributions to regulatory documents and responses.
8. Understands and effectively applies appropriate regulatory guidelines to drug development.
1. Ph.D. degree, Pharm D or equivalent in clinical pharmacology, pharmacokinetics, pharmacometrics, or a related field with more than 4 years of relevant industrial experience.
2. Demonstrates a sound knowledge of DMPK, clinical pharmacology and PK/PD principles, and possess modeling and simulation skills.
3. Experienced in PK modeling software/platforms including but not limited to NONMEM and population PK/PD modeling.
4. Ability to innovate and think creatively to support development activities and drug development process.
5. Effective communication and interpersonal skills.
1. Provides clinical data management oversight of outsourced clinical trials for phase I-III studies including: project management, vendor management, coordination of internal reviews, and approval of deliverables.
2.Act as liaison with CROs, third party data vendors, and EDC vendors.
3.Collaborates with internal clinical study team to ensure all stakeholders’ needs are addressed.
4.Assist as author/reviewer for CRFs/eCRFs, CCGs/eCCGs, and Data Management Plans, as well as mentoring junior staff in these activities.
5.Oversees database design and production, ensuring that CROs, vendors and internal staff meet the highest quality standards.
6.Oversees report specification development including patient profiles and other reports, listings and metrics supporting clinical development decisions, periodic regulatory filings and study oversight.
7.Accountable for external data vendor documentation, management, and reconciliation.
8.Oversight, management and mentoring responsibilities for both permanent and contracted staff in clinical data management.
9.Contributes to the strategic oversite of clinical programs and individual Genfleet sponsored trials.
10.Contributes to departmental process improvement, standards and integration of technology.
1.Bachelor’s Degree or above required,Experience with drug development in oncology required.
2.8-10+ years of clinical data management experience in the pharmaceutical industry, with increasing responsibility.
3.Demonstrated proficiency managing the lifecycle of clinical data projects.
4.Knowledge of and experience with EDC databases (especially Medidata RAVE), CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes.
5.Familiarity with GCP, ICH, CDE and FDA requirements as applicable for Clinical Data Management.