Recruitment Department:Production Technology Department - Process Development Department - Preparation

Recruitment position:Pharmaceutical development supervisor

Job responsibilities:

1. Formulation Process Characterization: Responsible for the characterization of formulation processes for clinical Phase III and future commercial products. Gather the research and production history of the product to draft assessment reports and process characterization plans for formulation parameters.Draft or review study protocols and reports for process characterization.Collaborate with the production department to develop sampling plans and oversee their execution.

2. Formulation Process Technology Transfer: Manage the technology transfer of clinical products, organize the development and tracking of transfer strategies and timelines. Coordinate the progress and handover between process development and production.  Review whether the transferred process parameters match the production line of the receiving party. Review gap analysis, transfer plans, transfer reports, process specifications, BOM tables, and other relevant documents.

3. Formulation Production Process Management and Technical Support: Participate in the review of production process-related documents.  Continuously monitor and collect production and R&D data and information for analysis.  Provide direct technical support for production process-related deviations and changes, conduct root cause analysis, and provide solutions.  Develop preventive and improvement plans.

4. Regulatory Submission Documentation: Draft regulatory submission documents for the formulation process development sections. Review regulatory submission documents for the formulation production sections.

5. Assist in Platform Development: Assist senior management in enhancing the development of formulation processes and platforms.

6. Other Duties: Perform other tasks as assigned by superiors.

Job Requirements:

1. Educational Background: Bachelor's degree or higher in Pharmacy, Pharmaceutical Science, Biology, or a related field. At least 3 years of relevant experience for candidates with a Master’s degree, or at least 5 years of relevant experience for candidates with a Bachelor’s degree in the biopharmaceutical industry.

2. Experience: Experience in aseptic filling, process transfer, and production support systems. Familiarity with the production processes and key control points of aseptic formulations, principles and validation of production equipment, risk assessment of process parameters, and research on process parameter ranges. Experience in process validation and a basic understanding of aseptic formulation development and CMC regulatory documents for biologics in China, Europe, and the United States.

3. Problem-Solving Skills: Strong problem-solving skills and the ability to ensure the timely and effective completion of project development.

4. Research and Collaboration:  Strong research capabilities, a good team spirit, and excellent communication skills. Ability to handle work pressure, high initiative, strong execution ability, and a strong sense of responsibility.

5. Language Skills: Good spoken and written English skills, capable of drafting the English portions of documents and materials.

6. Technical Proficiency:  Proficient in using office software such as Microsoft Office, Excel, PowerPoint, and Project.

7. Accuracy and Integrity: Must ensure the accuracy, truthfulness, and completeness of drafted/reviewed documents or data.

Please send your resume to email:hr@acroimmune.cn.