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