Discovery

Development

Testing

Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Antibody Drug Conjugates

Technologies & Platforms

Responsibilities

  • Carry out biophysical and industrial forensic analysis to support the development of protein therapeutics for early and late stage programs, including biophysical characterization for IND filing, non-conformance investigations, method development, qualification/validation and troubleshooting;
  • Help acquire, prepare and analyze drug product samples and extraneous matters (including microparticles) using a variety of spectroscopic, microscopic and other analytical methods in a phase-appropriate GMP environment;
  • Perform data collection and analysis, data witness and reviewing; authoring and reviewing technical reports in a timely manner to meet project milestones or deadlines.
  • Interact and communicate with internal colleagues and/or clients from many other functional areas to convey and update analytical results to support root-cause analysis and the closure of NC studies;
  • Develop, improve, optimize and transfer analytical methods to support regulatory submissions.
  • Build and lead analytical groups; and direct scientists to carry out laboratory testing, data analysis and results reporting in compliance with regulatory requirement

Basic Qualifications:

  • M.S or Ph.D. in analytical chemistry or relevant physical sciences with 5-10 years of industrial or research lab experiences with proven scientific accomplishments.
  • Hands on experiences in CD, DSC, particle counting and sizing, LC-MS, vibrational spectroscopy (IR, Raman) and microscopy (Optical, SEM and EDS, XPS) are expected.
  • Strong skills in sample preparation, experimental design and execution, and results analysis, sharing, and reporting;
  • Good team player willing to collaborate in a cross-functional work environment; Proactive in conveying project issues or updates to management and project leaders;
  • Appreciate feedbacks and expectations from other internal colleagues or clients for better alignment with company and department goals.
  • Excellent communication skills (both verbal and written) and interpersonal skills; Fluent in Chinese and English.
  • Lab experiences in pharmaceutical or biotech industries are advantageous

Primary Location: China – Shanghai

 

 

To apply please send your application to HR_Biologics@wuxiapptec.com

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