Senior Formulation Development Scientist

Job Responsibilities:  

• Develop and execute strategic formulation development plans aligned with organizational objectives. Direct formulation activities to ensure the creation of high-quality pharmaceutical formulations. Draw up working plans, schedules, and execute for pharmaceutical product development.
• Design and conduct experiments, interpret and report results and conclusions, troubleshoot, and mitigate product and process issues.
• Leading efforts to optimize pharmaceutical formulations for enhanced efficacy, stability, and manufacturability. Ensure formulations meet regulatory requirements and industry standards.
• Support new APIs/excipients sourcing and collaborate with cross-functional teams, including research, quality assurance, and regulatory affairs. Facilitate seamless coordination to integrate formulation development efforts into product development processes.
• Implement and maintain stringent quality control measures in formulation development processes. Ensure adherence to quality standards and regulatory guidelines.
• Stay informed about emerging technologies and trends in formulation development. 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 formulation research and collaborate with QC, QA, and regulatory affairs teams for compliance.
• Maintain accurate documentation of formulation development activities. Generate comprehensive reports to track progress and communicate findings to relevant stakeholders, including preparing and reviewing CTD submission documents.
  • Master's MPhil, or PhD in Pharmaceutical Science, Industrial Pharmaceutics, Chemistry, or related fields.

Job Requirements:

• At least five years of experience in formula and process development of pharmaceutical products.
• Hands-on experience in NMPA project development for pharmaceutical products.
• Experience in preparing CTD format documents for NMPA product registration.
• Experience in various dosage forms, with expertise in oral solid formulations being essential and other forms considered advantageous.
• Familiarity with pharmaceutical manufacturing equipment for oral solid products, and other dosage forms is a plus.
• Familiar with relevant pharmaceutical guidelines and regulations for NMPA CDE and ICH.
• Ability to develop research plans and schedules effectively, break down and arrange work according to the research plan, and implement concretely.
• Overall experience in the development of pharmaceutical products and related project management skills, able to manage multiple projects simultaneously.
• Strong abilities in data interpretation, troubleshooting, and problem-solving.
• 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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