Scientist/SeniorScientist,Bioanalysis（生物分析科学家/高级科学家）

面议

上海市

刷新时间：2022-01-14

职位描述

Key Responsibilities：

1.Developing bioanalytical strategies for various biologics development programs following internal SOPs and Health Authority guidance.

2. Responsible to ensure development of high-quality ligand binding assays used to support PK/PD/Immunogenicity assessments and subsequent validation and suppot of sample analysis.

3.Oversee reagent development to suppot the bioanalytical strategy. 4.Evaluate new technologies for analysis of large molecules and implement as needed.

5. Compile and interpret bioanalytical data,author and/or review of protocols and reports.

6.Assisting in preparation of regulatory documents including INDs, NDAs,and BLAs submission documents and being responsible for responding to Health Authority queries related to bioanalysis.

7.Acting as the bioanalytical liaison with clinical, and non-clinical internal cross-functional project teams and external collaborators.

8. Managing technology transfers of immunogenicity and PK methods and related bioanalytical activities(e.g.,development data,validation and study reports)to contract research laboratories and ensuring the scientific quality of data in order to meet US and OUS regulatory expectations.

9.Performing technical audits of existing contract research laboratories supporting bioanalytical work.

10.Reporting study sample results to stakeholders following the departmental policies and procedures and participate in tech transfers of assays to business partners and troubleshooting assays when problems arise.

11.Contributing to the preparation of technical reports and departmental SOPs and the preparation and presentation of scientific material at internal and external meetings and will be encouraged to publish as part of project publication plans.

12.Ensuring compliance and maintain required training in departmental SOPs, safety guidelines and other applicable regulations.

Qualifications and Experience：

1.PhD in biological sciences or related discipline with 8 years of relevant

experience or Masters in relevant scientific discipline with 10 years of relevant experience.

2.Excellent interpersonal, written and oral communication skills.

3.Experience managing the bioanalytical portion of non-clinical and clinical studies for biologics conducted at CROs.

4. Experience preparing regulatory documents related to the bioanalysis.

5. Proven technical expertise in developing and validating ligand binding assays in technologies such as ELISA, ECL (MSD) or Gyrolab; including PK/ADANab assay problem solving and analytical skills.

6. Understanding of the drug development process for biologics,especially as it

applies to bioanalysis.

7.Experience with sample management systems and Watson LIMS is a plus. 8. Strong understanding of the scientific/regulatory standards for bioanalysis of biologics,including knowledge of GLPs,21 CFR Part 11,FDA,EMA and other relevant Bioanalytical Guidances is important.

9. Proven track-record of performing large molecule bioanalytical sample analysis and knowledge and interpretation of PK data and potential impact of ADA on PK is a most.

10.Prior experience in representing functional area in cross-functional product teams.

11.Proven record of peer-reviewed publications in the relevant technical areas.

其他要求

招聘人数：1人
所属部门：药理学
职能类别：研发科学家/领军人才

公司介绍

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