Johnson & Johnson Careers
Senior Analytical Scientist
Shanghai, China; Shanghai, China
Requisition ID: 1805675818W
• Responsible for analytical method development, validation and transfer for OTC NPD projects；technical writing includes method validation protocol, report and test method;
• Conduct stability testing per stability study protocol, involve in OOS/OOT investigation;
• Responsible for establishing specifications for API, excipients and finished product, and participate qualifying the vendors and products if necessary;
• Responsible for the analytical research data/section of regulatory filing dossier and pro-vide necessary support for on-site inspection;
• Provide necessary supports for technical transfers from R&D to manufacturing sites, troubleshoot for analytical issues to support new product and marketed product fully meet the requirement of quality and compliance;
• Join the technical discussion with business partners, cooperate closely with AP Tech-nical Centre, US R&D centers and contract labs;
• Help with evaluation and introduction of new analytical technology and instrumentation to support new formulation and product development.
• Master degree or above, Pharmaceutical or Analytical Chemistry related.
• At least 3 years (PhD) or 5 years (MS) of experience with analytical development experi-ence, multinational pharmaceutical company work experience preferred.
• Rich Product Development Knowledge and Experience
• Knowledge of CFDA Regulations and ICH requirement.
• Familiar with GMP, GLP, etc.
• Fluent English and Chinese
Shanghai Johnson & Johnson Pharmaceuticals, Ltd. (7048)