• Lead, develop, optimize, scale-down and scale-up cell culture and bioreactor processes in a robust and economically viable way, including evaluating different cell culture media, feed formulations, and feeding strategies to improve product yield, quality and purity.

• Generate, manage, interpret, and maintain critical data in a highly organized manner; write and present technical reports to management.

• Perform and analyze Design of Experiment (DOE) studies to fully characterize processes. Support process validation studies and activities.

• Participate in the technology transfer of bioprocesses internally and externally. The work will involve working with commercial and clinical production facilities to ensure accurate technology transfer and successful large-scale production.

• Review process related documents to support internal biopharmaceutical filing. Collaborate and coordinate with colleagues from R&D, CMC, and quality teams.

• Lead/participate in instrument purchasing and equipment maintenance for process development labs.

• Provide input on the evaluations of CMO/CROs.

• Demonstrate effectiveness in collaborative projects in a matrix organization.

Qualifications

• PhD with 0-2+ years related experience, MS with 4+ years related experience or BS with 6+ years of related experience.
• Solid scientific background in cell culture, molecular biology, and cell biology.
• Must have strong analytical skills and upstream experience of cell culture and bioreactor processes development for biologics production.
• Extensive knowledge in process optimization, scale-down, scale-up, and technology transfer to the cGMP manufacturing facilities.
• Hands-on experience with viral vector, vaccine, cell and gene therapy products is preferred.
• Experience in process development and optimization using statistical tools is (DOE and data analysis) is desirable.
• Knowledge of process characterization and process validation of biological products is a plus.
• Excellent communication and project management skills to work in a multidisciplinary team and manage CMO to meet aggressive timelines.
• Fluent in English and Chinese.
• This position is based in Shanghai and may require up to 10% domestic or international travel.

Primary Location
China-Shanghai-Shanghai-
Organization
J&J (China) Investments Ltd (7046)
Job Function
R&D
Requisition ID
1905763200W