Job responsibilities:
- Technology transfer:
As the recipient of production technology transfer, conduct a gap analysis with the process technology transferor or customer and complete the technology transfer work. Timely coordinate and communicate with the CMC team regarding the status of project technology transfer, including but not limited to technology transfer status, technical challenges, material preparation status, and product quality standards for central control and release.
Prepare and promptly update project-related documents, including but not limited to changes, process flows, plans, master production records, sampling plans, bills of materials, and regulatory submission documents.
Update the clients and CMC team on the latest progress of the project in a timely manner, and communicate and coordinate with clients on process and technical topics.
Coordinate with the coupling, formulation, QA, QC, and R&D departments regarding the execution of process transfer, confirmation, and production.
- Production material management
Calculate the materials required for production based on the technology transfer documents, and submit the procurement request.
Track the procurement progress of materials and confirm the sources of new materials. Ensure that all materials required for the project are ready before production.
Support the production department in implementing the purchasing and receiving processes.
- Project implementation
Lead the implementation of the project and ensure that the requirements proposed by the client during the process transfer are clearly communicated to the production team.
Initiate and follow up on production, QC testing, and sample transfer updates. Ensure that customers, PMs, and CMC leaders receive timely updates on project progress.
Solve problems that arise during the production process, take charge of investigating deviations related to the production process, and enhance the efficiency of production execution.
Responsible for PIP during customer visits and production.
Draft or review production batch records.
Participate in optimizing production processes to ensure that production plans are executed as scheduled.
Write production reports or related technical reports.
Job requirements:
Master's degree or above, with knowledge and experience in the pharmaceutical industry, and at least 2 years of work experience in upstream or downstream production, process development, or technology transfer;
Familiar with relevant regulations and cGMP in biopharmaceuticals
Good communication, teamwork, and logical thinking skills, able to write Chinese/English proposals, reports, and other documents
Possess excellent English reading, writing, and oral communication skills