北京招聘

Role : Scientist

Role Band : R1
Reporting To : Clinical Lead, China
Work Location : Beijing

Job Responsibilities:

Bioanalytical CRO selection/Qualification

• Bioanalytical CRO identification for conduct of BE studies in China
• Performing Due diligence of Bioanalytical CROs
• Understanding of Bioanalytical Regulatory requirements as per CFDA and USFDA, to enable shortlisting of Bioanalytical CROs
• Exposure to bioanalytical systems and processes, SOPs, Audit trails, CFDA audit history, CFDA Bioanalytical guidelines, FDA/ICH Bioanalytical guidelines
• Basic understanding of quantitation of drugs by LC_MS/MS instrument for BE Studies.
• Project management of biostudies focusing on Bioanalytical part of the study and also provide additional project management support in providing documents like protocol, EC submissions, OHGRA approval, Import license etc.

II. Operational Management of outsourced bioanalytical studies at different CROs

• Monitoring of bioanalytical studies at CROs
• Ensure availability of all pre-requisites before initiation of Bioanalysis of clinical/BE study samples
• Perform on-site audit to review validation data and bioanalysis data generated during study
• Direct interaction with CRO's while conducting bioanalytical studies
• Follow-up with CROs on the bioanalytical timelines
• Ensure Bioanalytical CRO has all the requirements like availability of working standards to initiate Bioanalytical Method Development and validation
• Verify the data as per source documents

• Coordinate with Bioanalytical CROs, Hospital sites and India team to facilitate the protocol finalization process

• Collaborate with Bioanalytical CROs and Hospital sites for sample shipment before initiating bioanalysis of subject samples

1. I. Exposure to development of Bioanalytical methods for generics
2. Exposure to development and validation of Bioanalytical methods for generics using LC-MS/MS as per different regulatory requirements such as US FDA, CFDA and ICH
3. Hands-on experience of working on bench for development and validation of Bioanalytical methods using LC-MS/MS
4. Review of bioanalytical method development/validation protocols, bioanalytical study plans & bioanalytical/validation data/reports
5. Exposure to LC-MS/MS instrument handling and aware of IQ/OQ/PQ and calibration of LC-MS/MS and also aware of access rights privileges and LIMS on these systems
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Job Requirements

• M.Sc./M. Pharm with an experience of 5 – 8 years in the area of GLP bioanalysis for generic BA/BE studies and basic understanding of non-clinical bio analysis
• Should have basic knowledge of pharmacokinetics, Biopharamceutics, and GLP concepts.

Dr. Reddy’s, founded in 1984 and headquartered in Hyderabad, India. The company owns 21,000+ employees and is the second largest Indian pharmaceutical company in the world and one of the ***0 global generics companies. Dr. Reddy’s business spans Pharmaceutical Services & Active Ingredients (PSAI), Global Generics, Proprietary Products and Biosimilars, in 80 countries across the world.
Dr. Reddy’s has been developing business in China for over 20 years and is known as the *** multinational imported generics pharmaceutical company in the country. In 2000, we set up Kunshan Rotam Reddy Pharmaceutical Co Ltd as a joint venture involved in manufacturing, sales and marketing. In 2010, we established Dr. Reddy’s Laboratories Ltd (Beijing) Representative Office in China to manage regulatory affairs and import drug filing. In 2020, we set up WOFE Dr. Reddy’s (Beijing) Pharmaceutical Co. Limited. and Dr. Reddy’s (Beijing) Pharmaceutical Co. Limited Shanghai Branch to enable commercial related activities in China, as part of our expansion plan.

In Dr. Reddy’s China, all Reddy’s people pull together, trust and respect each other and work hand in hand. As a global enterprise, we provides our employees with a professional working environment with high-standard and strict requirements which makes our work more professional and reliable. We keep growing, and creating more opportunities for the future development, we provides a plentiful external training opportunities, upgrading employees’ skills, let each employee grow together with us.
As a family care about global health, we are here to share our knowledge and product to bring good health to China and the world.
瑞迪博士(Dr. Reddy’s)成立于1984年，总部位于印度海德拉巴，拥有21,000多名员工，是全球第二大印度制药公司、全球仿制药公司***0之一。瑞迪博士的制药服务和原料药，全球仿制药，专利药和生物仿制药业务遍及全球80个国家。
瑞迪博士在中国已经发展20多年，是中国***大跨国进口仿制药制药公司。2000年，我们成立了集生产、销售和市场于一体的合资企业昆山龙灯瑞迪制药有限公司，2010年，我们在中国设立瑞迪博士实验室（北京）代表处，进行进口药品注册申报事务，2020年，我们成立外商独资企业瑞迪博士（北京）药业有限公司和瑞迪博士（北京）药业有限公司上海分公司，在中国开展产品商业相关活动，这是我们业务扩张计划的一部分。
在中国，瑞迪人依旧齐心协力，彼此信任，尊重彼此携手前行。作为一家全球化的企业，为员工提供高标准严要求的专业工作环境，让工作更为专业可靠。瑞迪公司通过不断壮大，给未来发展创造了更多机遇，我们也为员工提供丰富的外部培训机会，提升员工技能，让每位员工和我们一同成长。
加入瑞迪，我们一起聚梦瑞迪，共塑健康世界！