• Lead/ assist analytical team to develop physiochemical and functional assays to support process and product development as well as product release.

• Manage /perform analytical experimental design, execution and writing testing methods and qualification protocols/reports.

• Work closely with other CMC colleagues to ensure timely analytical support for cell line, process and formulation development.

• Oversee /contribute comparability strategies and CQA assessments

• Provide supervision for assay transfer and oversee CMO activities.

• Review and approve qualification reports and QC SOPs; address testing related issues at CMO's in collaboration with Quality.

• Manage/contribute reference standards and oversee critical reagent strategy.

• Manage/coordinate Analytical Development resources and strategic planning to support early and late stage projects.

• Drive innovation through deep understanding of new technologies and methods in analytical development

• Coordinate and collaborate with Discovery and other CMC functions and develop strategies to meet project as well as corporate timelines

• Contribute to the IND filings

Requirements:

• 
  BS/BA or MS or PhD in Chemistry, Analytical Chemistry, Chemical Engineering, Biotechnology, Biochemistry or related field. Number of years of industry experience commensurate with job titles

• Hands on experience on analytical technologies such as HPLC, CE, peptide map, mass spectrometry, ELISA, MS, and cell-based bioassay

• Significant experience with protein characterization and comparability assessment is essential

• Direct experiences on transfer of analytical methods to CMO's and in authoring analytical sections for regulatory submissions preferred

• Experiences with method validation, process validation and BLA submission is preferred

• Leadership experience with proven capability as a successful leader in a strategic multifunctional environment is plus

• Knowledge of cGMP's, regulatory guidelines, validation practices, and other relevant regulatory requirements.

• Extensive knowledge and experience in IND filing

• Must be scientifically knowledgeable, team-orientated, and passionate about biopharmaceutical development

• Excellent interpersonal communication and presentation skills. Ability to work independently and multitask in a fast-paced environment

• Responsible, organized and disciplined record keeping

• Self-motivated, collaborative, and effective communication skill

上班地址：上海张江哈雷路866号