Job Description:

• Develop and direct strategic analytical research plans aligned with organizational goals, ensuring robust data analysis and interpretation.
• Oversee the development and validation of analytical methods for research and product development, ensuring compliance with regulatory standards.
• Prepare and meticulously review CTD submission documents, chromatograms, raw data records, and other essential materials.
• Create necessary documents like protocols and reports for analytical research projects.
• Maintain rigorous quality control measures for data integrity and accuracy in analytical processes.
• Perform instrument calibration and maintenance with precision.
• Handle routine laboratory tasks daily with precision and care.
• Demonstrate strong project management skills to meet project timelines effectively.
• Show a comprehensive understanding of regulatory requirements in analytical research and collaborate with QC, QA and regulatory affairs teams for compliance.

Job Requirements:

• Hold a Master's, MPhil, or PhD in Pharmaceutical Science, Analytical Chemistry, or related fields 
• Possess a minimum of five years of experience in developing analytical methods and conducting quality research on pharmaceutical products 
• Proficient in operating analytical instruments such as HPLC, GC, and others 
• Demonstrate laboratory management expertise and a firm grasp of R&D quality system compliance 
• Knowledgeable about relevant pharmaceutical guidelines and regulations for NMPA CDE and ICH. Skilled in developing effective research plans and schedules, organizing work according to these plans, and implementing them efficiently 
• Have extensive experience in the development of oral solid pharmaceutical products and related project management, capable of handling multiple projects concurrently 
• Possess strong abilities in data interpretation, troubleshooting, and problem-solving 
• Exhibit excellent communication skills to engage effectively with internal and external stakeholders, conveying complex analytical concepts clearly and facilitating collaboration, knowledge sharing, and decision-making processes within the R&D team and across departments 
• Strong commitment to achieving objectives and exceptional problem-solving skills to address complex challenges effectively. 
• Adept interpersonal skills for building relationships and fostering a productive work environment.

Work location: Yuen Long
Shuttle bus pick up point: Chai Wan/ Quarry Bay, Lam Tin, Kowloon Tong, University Station, Long Ping Station

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