Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms

Responsibilities

  • Lead tech transfer and manufacturing coordination for the designated production projects at MFG1.  Serve as CMC leader or single point of contact (SPOC) in the overall CMC team and when interacting with external clients for manufacturing related discussions
    • Lead the tech transfer activities including gap analysis, manufacturing process discussion, manufacturing document preparation.
    • Clearly understand and be responsible to track status of tech transfer, production progress and technical challenges/achievement of production projects, and make appropriate presentation to clients and management
    • Ensure client requirements are clearly communicated to production team and management
    • Write technical and production reports per requirement of the projects assigned
    •  Lead/support for preparation and hosting of regulatory inspection and client/QP audit of MFG1 for projects assigned
    • Participate in the review/translation of production batch records, deviation, change control, CAPA and regulatory observation response of projects assigned
  • Host client visit and present overview of MFG1 facility and capability
  • Address regulatory observations/audit findings and CAPA of projects assigned
  • Participate in PD/MFG1/MFG2 technology communication and MFG1 manufacturing summary, more specifically continuous improvement of
  • PD/MFG1/MFG2 platform technology alignment
  • Optimization of production execution processes
  • Reduction of deviations/investigations from technology aspect
  • Work with various MFG1 teams (and lead as appropriate) on initiatives including, but not limited to, business process improvements, SOP/MBR template updates, production scheduling optimization etc.

 

Basic Qualifications:

  • Master/Ph.D. degree holder in Biotechnology/Chemical Engineering/Biology or related fields. B.S. degree holders with more than 5 years of biopharmaceutical industry background can also be considered.
  • Pharmaceutical/biotechnology industry background , including areas but not limited of process development/CMC program management/coordination, QC, manufactory
  • Strong communication and social skills in English and Chinese, be fluent in speaking, writing and reading in both languages.
  • be proficient with Microsoft Office software (excel, project, PowerPoint, word)

 

Primary Location: China – Wuxi

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

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