杭州招聘

工作职责:

Key accountabilities:

？ Technical Leadership in the stability study design of ADQC stability projects, from batch selection, stability indicating assay confirmation to time points design.

？ Responsible of stability plan establishment and maintenance.

？ On time delivery of the protocols and/or reports of ADQC stability studies and ensure the effectiveness of the protocol training.

？ Creation of the effective and clear tracking chart and update template of stability study status, on-time tracking of stability study status and regular update of the study status proactively.

？ Stability data analysis using statistical software together with the ALs to provide scientific rationales on the shelf-life definition and further internal release limit setting.

？ Lead stability deviation investigation and support stability OOS investigation as the stability SME.

？ Work with the team for continuous improvements.

任职资格:

PERSONAL QUALIFICATION

1.20 Education Background: Bachelor or above degree in Biochemistry, Biology, or related major.

1.21 Professional training: optimal cGMP training, familiar with the stability study requirements in Pharmacopeia, ICH, and Health Authorities.

1.22 Work Experience: 2 to 5 years of Biopharmaceutical Industry experience in stability study, familiar with Biologics production process and analytical assays, optimal cGMP experience.

1.23 Skills: statistical data analysis (e.g., excel or minitab, or other statistical software), cross-functional cooperation, communication skills and on-time-oriented project management. Fluent Spoken and Written English.

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