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Position: Senior Analytical Scientist
Department: APAC Self Care R&D
Line Manager Position: AP Analytical Manager
The position will be the analytical technical expert for OTC drug development projects. According company and R&D’s policy, develop and validate analytical methods for OTC durg development to meet the requirement for AP OTC market growth demands. Support stability study, analytical testing for formulation. The position will be reporting to AP R&D regional analytical mange.
• 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 provide 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 instrumenta-tion to support new formulation and product development.
• Actively& timely communicate and collaborate with project team members and cross-functions. Strictly follow the cGMP and EHS regulations and requirements.
• Time needed for method development &validation for new drug product development
• Percentage of compliance to cGMP, EHS and J&J regulations
• Effectiveness of teamwork
• Percentage of Deficiencies from new drug registrations and regulatory audits
• Percentage of Non-technical issue from analytical perspective for developed and mar-keted products
• Master’s degree or above, Pharmaceutical or Analytical Chemistry related.
• At least 3 years (PhD) or 5 years (Master) of experience with analytical development experience. Multinational pharmaceutical company R&D work experience is preferred.
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• Extensive experience in pharmaceutical industry, including R&D, Analytical develop-ment, QC/QA; familiar with GMP, GLP etc.
• Solid background and proficiency in impurity, dissolution method development for drug products.
• Knowledge of requirement on NMPA Regulations, ICH, GMP, GLP, etc. would be a plus.
• Good team player. Experience in project coordination and project leader would be a plus.