Senior scientist of Analytical Development (CAR-T)
南京传奇生物科技有限公司
- 公司规模:1000-5000人
- 公司性质:上市公司
- 公司行业:制药/生物工程
职位信息
- 发布日期:2020-11-02
- 工作地点:南京-江宁区
- 招聘人数:若干人
- 工作经验:1年经验
- 学历要求:博士
- 职位类别:医药技术研发管理人员 生物工程/生物制药
职位描述
Responsibilities include, but are not limited to:
1. Work with a cross-functional team to develop, adapt, remediate, execute, and document analytical methods to study and characterize processes supporting Legend CAR-T programs.
2. Design and execute method development and qualification in support of lead candidate selection, process development, product release and stability, product characterization, investigation, and process performance qualification.
3. Participate or take a lead role in a cross-functional team to transfer technology to cGMP manufacturing partners or US CMC team.
4. Support tech transfer of methods for external QC testing for manufacturing.
5. Contribute to development of novel technologies for CAR-T.
6. Successfully execute and document laboratory procedures and experiments with great attention to detail.
7. Assist in the development of standard operating procedures, analytical test methods, analytical sampling plans involving immunoassays, and molecular biology techniques.
8. Write, review, and edit accurate technical documents for regulatory filings (IB, IND, etc.)
9. Maintain, calibrate, and operate analytical equipment and instruments.
10. Work with a cross-functional team to advance the development of Legend programs.
11. Other duties as assigned.
Position Requirements & Experience:
1. Ph.D. Degree in immunology, molecular and cellular biology or a related discipline, and at least 2 years of industry experience in multi-scale characterization studies is required.
2. Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, analytical method development, technology transfer, method qualification/validation, and process development.
3. Analytical method development and qualification experience in molecular biological techniques such as quantitative PCR (qPCR), immunoassay, and flow cytometry.
4. Experience with cell therapy products, including T cells, is a plus.
5. Demonstrate a strong skill set and knowledge in analytical assay development and assay optimization.
6. Ability to follow laboratory procedures with attention to detail and successfully execute experiments at the bench.
7. Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
8. Ability to work in a fast-paced, start-up environment.
9. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
10. Ability to work independently and as part of a team.
公司介绍
联系方式
- 公司地址:建国路91号院
- 电话:18845096218