Recruitment Department:Production Technology Department - Process Development Department - Drug Product
Recruitment Position:Drug Product Development (DPD) Supervisor
Job Responsibilities:
1. DP Process Characterization: Responsible for the characterization of DP processes for clinical Phase III and future commercial products. This includes obtaining the research and production history of the product to draft evaluation reports and characterization plans for DP processes. Draft or review study protocols and reports for process characterization, collaborate with the production department to develop and supervise the execution of sampling plans.
2. DP Process Technology Transfer: Responsible for managing technology transfer for clinical products. Organize the development and tracking of technology transfer strategies and timelines, coordinate the progress and handover between process development and production, and review whether transferred process parameters match the receiving party's production line. Review gap analysis, transfer protocols, transfer reports, master formulas, BOMS, and other documents.
3. DP 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 Dossier Drafting and Review: Responsible for drafting regulatory submission sections related to DP process development and reviewing documents related to DP production.
5. Assist in the Improvement of DP Processes and Platforms: Assist senior management in enhancing the development of DP processes and platforms.
6. Perform other duties as assigned by superiors.
Job Requirements:
1. 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 or related fields.
2. Experience in aseptic filling, process transfer, and production support systems. Familiarity with the production processes and key control points of sterile products, principles and validation of production equipment, risk assessment of process parameters, study of process parameter ranges, and process validation. Knowledge of aseptic formulation development and CMC regulatory requirements in China, Europe, and the United States is preferred.
3. Extensive problem-solving skills and the ability to ensure the timely and effective completion of project development.
4. Strong research and development capabilities, excellent team collaboration, and communication skills. Ability to handle work pressure, high initiative, strong execution ability, and a strong sense of responsibility.
5. Good oral and written English skills, able to complete the writing of English documents and dossiers.
6. Proficient in using office software such as Microsoft Office, Excel, PowerPoint, and Project.
7. Must ensure the accuracy, truthfulness, and completeness of drafted/reviewed documents or data.
Please send your resume to email:hr@acroimmune.cn.
