Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms

Responsibilities

  • A. Tech Transfer Lead & Functional Leader
    1. Lead and complete the new production introduction assessment.
    2. Partner with Process Development to ensure successful process transfer.
    3. Monitor the manufacturing process, when the situation is needed need to be observe or provide recommendation on-site.
    4. Serve as a reviewer of tech transfer protocol, MBR, PFD, manufacturing related documentation, etc.
    5. Attend project meetings.
  • B. Upstream, Downstream, and Formulation, Fill and Finishing Process Science
    1. Perform the satellite run activates including upstream and downstream.
    2. Lead cross functional technology transfer teams for upstream and downstream operations.
    3. Serve as the science and technical expert during the tech transfer, gap analysis, troubleshooting of manufacturing processes
    4. Perform satellite run upstream and downstream activates and analysis
    5. Design and perform deviation related experiments to determine and understand the possible cause factors that related to the event.
    6. New manufacturing equipment evaluation design and planning.
    7. Lead cross functional technology transfer teams for aseptic formulation and sterile filling and finishing operations.
  • C. Process Performance Qualification
    1. Lead PPQ/PV (process performance qualification or process validation) preparations & execution;
    2. Participate/contribute to PC (process characterization).
  1. D. Deviation Investigation
    1. Lead or participate in key investigations of deviations.
    2. Communicate with the client regarding the deviation investigation results.
    3. Investigate, identify root cause, and identify CAPA for manufacturing deviations.

Basic Qualifications:

  • Education and working experience.

– Category1: B.S. in Biology, Biochemistry, Chemistry, Biochemical engineering, Chemical Engineering, and Life Science related majors, with 2-5 years pharmaceutical, manufacturing, QC, QA, Process Development, Food science related experience.

– Category2: M.S. in Biology, Biochemistry, Chemistry, Chemical Engineering, and Life Science related majors, with 2-5 years pharmaceutical, manufacturing, QC, QA, Process Development, Food science, related experience.

– Category 3: M.S. or Ph.D. in Biology, Biochemistry, Chemistry, Chemical Engineering, and Life Science related majors, with 5< years pharmaceutical, manufacturing, QC, QA, Process Development, Food science, related experience.

  • Strong written, reading, and oral English communication skills.
  • Must be able to work within multifunctional teams.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to effectively present information to top management, public groups, and/or boards of directors.
  • Familiar with cGMP and CMC.
  • Author technical reports and protocols in support of cGMP activities.
  • Management and manufacturing experience is preferred someone with over 8 years’ experience.

 

Primary Location: China – Wuxi

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

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