【USP招聘】Director, Biologics

Location 工作地点:

Waigaoqiao Free Trade Zone, Shanghai

Title 职位:

Director, Biologics

‍Director, Biolo

Roles and Responsibilities 工作职责:

• Responsible to ensure that CBL adheres to USP’s mission, goals and objectives.

• Ensure CBL meets and complies with the USP guidelines and other requirements.

• Perform technical supervision and training of CBL staff to build capabilities for core compendial work.

• Implement USP Quality Management Systems in CBL.

• Review data, edits and release reports from CBL.

• Responsible for review and implementation of SOPs, protocols, etc.

• Direct and implement collaborative testing project and verification project works in physicochemical analysis, bioassay and microbial testing relevant to public standards.

• Assist in the USP-NF activities for General Chapters, Monographs and Reference Standard development in the area of proteins, peptides, carbohydrates, or other biologics.

• Perform supervisory duties such as performance reviews, objective setting, staff development and career counseling.

• Propose annual budgets, projects resources, capital and personnel needs for the CBL.

• Work with management team to develop and implement strategies and plans to advocate USP biologics standards in China.

• Build capabilities to conduct classroom and laboratory based Pharmacopeial Education programs for biologics in China.

• Participate in USP cross-functional and global teams as appropriate.

• Support VP & Global head in the integration of global Biologics Labs.

• Assist in the development and implementation of safety protocols impacting CBL personnel.

• Demonstrate a strong desire to continue learning and grow personal capability.

• Perform other duties as assigned.

Minimum Requirements 要求:

Ph.D.in biology or related fields with laboratory and industry experience, no less than 15 years in the areas of biological product research and development.Excellent communication in English is a must. The candidate should have comprehensive experience on analytical methods for the various biological products such as peptides, proteins, carbohydrates, and other macro molecules in addition to knowledge on quality management system and basic regulatory filing requirements. Management experience with a group of scientists and good communication skills with multiple disciplines are essential.

Knowledge,Skills & Abilities 专长，技术和能力:

A comprehensive understanding of the science involved in the development of biopharmaceutical standards and reference materials is required. A basic understanding of the processes of the USP is desired. Demonstrate deep knowledge and strong skills in the areas of physicochemical analysis, bioassay for the biological medicines and microbiology. Laboratory experience must include chromatography-based techniques,electrophoresis, colorimetric assays, mass spectrometry, immunological methods,method development and validation. Experience in the organization and facilitation of collaborative studies is desirable. Excellent technical writing and verbal communication skills in English are required. Good interpersonal skills and proven ability to function in a team-oriented environment are necessary. A proven leadership and staff management skill is a must.

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Contact us 联系我们:

‍Interested candidates please e-mail your latest resume (in English & Chinese) with subject line “Apply Director, Biologics” to Vivi Zhou at vxz@usp.org

了解完整信息，请点击微博正文链接。

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